Specialty APIs
By the PharmaTradz BD Team · Updated 18 October 2026
High-potency, hard-to-make and soon-to-be-generic active ingredients, biologic drug substances and plasma-derived products: the molecules where finding a qualified source takes real work.
For each molecule you can see what kind of API it is, when generic or biosimilar entry is expected in the US and EU, and how many active US Drug Master Files exist, which is a quick guide to how many qualified sources there are. Send us an enquiry and we check suppliers' GMP status and regulatory files before we introduce anyone. Buyer and supplier details stay private until both sides agree to talk.
79High-potency
65Hard to make
74Going generic
101Biosimilar substance
35Plasma-derived
314 of 314 shown · 80 have a full API page
| Molecule | Type | US generic / biosimilar entry | EU entry | US DMFs | |
|---|---|---|---|---|---|
| Talazoparib tosylate Going genericHigh-potency Oncology | PARP inhibitor | Patent expiry; entry not confirmed2029 (2032 with pending PTE) | Protected beyond 20332034 | 0 | Enquire |
| Ixazomib High-potency Haematology (myeloma) | Cytotoxic | Patent expiry; entry not confirmedAug 2027 | No confirmed date | 7 | Enquire |
| Ferric derisomaltose Hard to make Haematology (IDA) | Iron complex | Patent expiry; entry not confirmedAug 2029 (compound patent) | No confirmed date | 1 | Enquire |
| Inclisiran Hard to make Cardiology (LDL-C) | Oligonucleotide | Patent expiry; entry not confirmedDec 2029-Aug 2034 | Patent expiry; entry not confirmedDec 2030 (regulatory protection, est.) | 3 | Enquire |
| Plecanatide Hard to make Gastroenterology (CIC, IBS-C) | Peptide | Patent expiry; entry not confirmedJan 2028 (compound patent) | No confirmed date | 6 | Enquire |
| Lorlatinib High-potency Oncology (lung) | Kinase inhibitor | Patent expiry; entry not confirmed2033 | Protected beyond 20332034 | 1 | Enquire |
| Trabectedin Hard to makeHigh-potency Oncology (sarcoma, ovarian) | Complex synthesis, cytotoxic | Patent expiry; entry not confirmedJan 2028 | No confirmed dategeneric authorised Apr 2025 | 7 | Enquire |
| Lurbinectedin Hard to make Oncology (SCLC) | Complex synthesis | Patent expiry; entry not confirmedDec 2029 (compound patent) | Protected beyond 20332036 (regulatory protection, est.) | 8 | Enquire |
| Midostaurin Going generic Haematology | Kinase inhibitor | Patent expiry; entry not confirmedOct 2028 (use patent) | No confirmed date | 9 | Enquire |
| Trametinib dimethyl sulfoxide Going genericHigh-potency Oncology | Kinase inhibitor | Patent expiry; entry not confirmedNov 2027 (compound patent + paediatric) | No confirmed date | 10 | Enquire |
| Nusinersen Hard to make Neurology (SMA) | Oligonucleotide | Patent expiry; entry not confirmedDec 2030 (compound patent) | No confirmed date | 9 | Enquire |
| Patisiran Hard to make Neurology (hATTR) | Oligonucleotide | Patent expiry; entry not confirmedAug 2032 (compound patent) | No confirmed date | 0 | Enquire |
| Defibrotide sodium Hard to make Haematology (VOD) | Oligonucleotide | Patent expiry; entry not confirmedto 2032 (non-compound patents) | No confirmed date | 0 | Enquire |
| Crizotinib Going genericHigh-potency Oncology | Kinase inhibitor | Patent expiry; entry not confirmed2029 | Patent expiry; entry not confirmed2027-2028 | 4 | Enquire |
| Ponatinib High-potency Haematology (CML, Ph+ ALL) | Kinase inhibitor | Patent expiry; entry not confirmedJan 2027 | No confirmed date | 4 | Enquire |
| Sofosbuvir + velpatasvir Going generic Hepatitis C | Antiviral | Patent expiry; entry not confirmed2033 | Patent expiry; entry not confirmed2032 | 0 | Enquire |
| Siponimod Going genericHigh-potency Neurology | S1P modulator, immunomodulator | Patent expiry; entry not confirmedAug 2028 (compound patent) | No confirmed date | 6 | Enquire |
| Binimetinib Going generic Oncology | Kinase inhibitor | Patent expiry; entry not confirmedMar 2027 (Aug 2027 if PTE granted) | No confirmed date | 6 | Enquire |
| Linaclotide Hard to makeGoing generic Gastroenterology | Peptide | Entry expectedMar 2029 (settlements) | No confirmed date2027-2036 | 16 | Enquire |
| Niraparib High-potency Oncology (ovarian, prostate) | PARP inhibitor | Patent expiry; entry not confirmedApr 2029 (earliest DS patent) | No confirmed date | 8 | Enquire |
| Pasireotide Hard to make Endocrinology (Cushing's, acromegaly) | Peptide | Patent expiry; entry not confirmedDec 2026 (compound patent) | No confirmed date | 0 | Enquire |
| Ribociclib High-potency Oncology (breast) | Kinase inhibitor | Patent expiry; entry not confirmedJun 2028-Nov 2031 | No confirmed date | 9 | Enquire |
| Letermovir Going generic Infectious disease | Antiviral | Patent expiry; entry not confirmed2029 | Patent expiry; entry not confirmed2029 | 10 | Enquire |
| Carfilzomib High-potency Haematology (myeloma) | Cytotoxic | Patent expiry; entry not confirmedJan 2027 | No confirmed date | 19 | Enquire |
| Venetoclax Going genericHigh-potency Haematology | BCL-2 inhibitor | Patent expiry; entry not confirmedJun 2031 (compound patent) | No confirmed date | 8 | Enquire |
| Lenvatinib mesylate Going genericHigh-potency Oncology | Kinase inhibitor | Entry expectedJul 2030 (settlements) | Patent expiry; entry not confirmed2027 | 14 | Enquire |
| Dalbavancin hydrochloride Hard to makeGoing generic Infectious disease | Fermentation-derived, semi-synthetic | Generics/biosimilars on the marketNov 2025 | No confirmed date | 4 | Enquire |
| Riociguat Going generic Respiratory | SGC stimulator | Generics/biosimilars on the marketOct 2026 | Patent expiry; entry not confirmed2028 | 6 | Enquire |
| Encorafenib Going generic Oncology | Kinase inhibitor | Patent expiry; entry not confirmed2030 (2031 with pending PTE) | No confirmed date | 3 | Enquire |
| Etrasimod High-potency Gastroenterology (UC) | Immunomodulator | Patent expiry; entry not confirmed2030 (2035 if pending PTE granted) | Protected beyond 20332034 | 3 | Enquire |
| Abaloparatide Hard to make Osteoporosis | Peptide | No confirmed date | Patent expiry; entry not confirmedDec 2032 (regulatory protection, est.) | 3 | Enquire |
| Acalabrutinib High-potency Haematology (CLL, MCL) | Kinase inhibitor | Patent expiry; entry not confirmedNov 2026 (earliest DS patent) | No confirmed date | 7 | Enquire |
| Ozanimod hydrochloride Going genericHigh-potency Immunology, Neurology | S1P modulator, immunomodulator | Patent expiry; entry not confirmed2033 | Protected beyond 20332034 | 4 | Enquire |
| Pembrolizumab Biosimilar substance Oncology | Monoclonal antibody | Patent expiry; entry not confirmed2028 | Entry expected2031 (including SPC) | – | Enquire |
| Ivacaftor Going generic Rare disease | CFTR modulator | Patent expiry; entry not confirmed2028 | Patent expiry; entry not confirmed2027 | 15 | Enquire |
| Ferumoxytol Hard to make Haematology (IDA) | Iron complex | Generics/biosimilars on the marketJan 2021 | No confirmed date | 3 | Enquire |
| Relugolix High-potency Oncology (prostate), women's health | Hormone | Patent expiry; entry not confirmedJan 2029 | No confirmed date | 17 | Enquire |
| Etelcalcetide Hard to make Nephrology (secondary HPT) | Peptide | Patent expiry; entry not confirmedJul 2030 (compound patent) | No confirmed date | 5 | Enquire |
| Ravtansine High-potency Oncology (ADCs) | ADC payload | No confirmed date | No confirmed date | 0 | Enquire |
| Osimertinib mesylate Going genericHigh-potency Oncology | Kinase inhibitor | Patent expiry; entry not confirmed2032 (compound patent) | Patent expiry; entry not confirmed2032 (compound patent + SPC) | 6 | Enquire |
| Lumacaftor Going generic Rare disease | CFTR modulator | Patent expiry; entry not confirmed2031 | Patent expiry; entry not confirmed2030 | 1 | Enquire |
| Ixabepilone Hard to make Oncology (breast) | Complex synthesis | No confirmed date | No confirmed date | 1 | Enquire |
| Cariprazine hydrochloride Going generic Psychiatry | Antipsychotic | Patent expiry; entry not confirmedSep 2029 (Mar 2030 with paediatric) | No confirmed date | 19 | Enquire |
| Deutetrabenazine Going generic Neurology | VMAT2 inhibitor | Entry expectedApr 2033 (settlements) | No confirmed date | 7 | Enquire |
| Dabrafenib High-potency Oncology (melanoma, lung) | Kinase inhibitor | Patent expiry; entry not confirmedJan 2030 | No confirmed date | 7 | Enquire |
| Calicheamicin High-potency Oncology (ADCs) | ADC payload | No confirmed date | No confirmed date | 2 | Enquire |
| Bictegravir + emtricitabine + tenofovir alafenamide Going generic HIV | Antiviral | Protected beyond 2033Apr 2036 (settlements) | Patent expiry; entry not confirmed2033 | 8 | Enquire |
| Tucatinib Going generic Oncology | Kinase inhibitor | Patent expiry; entry not confirmed2031 (2034 with pending PTE) | Patent expiry; entry not confirmed2031 | 8 | Enquire |
| Monomethyl auristatin e High-potency Oncology (ADCs) | ADC payload | No confirmed date | No confirmed date | 3 | Enquire |
| Alectinib High-potency Oncology (lung) | Kinase inhibitor | Patent expiry; entry not confirmedMay 2031 | No confirmed date | 9 | Enquire |
| Elagolix High-potency Women's health (endometriosis) | Hormone | Patent expiry; entry not confirmedJul 2029 | No confirmed date | 21 | Enquire |
| Degarelix Hard to make Oncology (prostate) | Peptide | Patent expiry; entry not confirmedto 2032 (non-compound patents) | Generics/biosimilars on the marketauthorised Sep 2023 | 9 | Enquire |
| Fidaxomicin Hard to makeGoing generic Infectious disease | Fermentation-derived | Generics/biosimilars on the marketJul 2025 | No confirmed date | 6 | Enquire |
| Cabazitaxel Hard to makeHigh-potency Oncology (prostate) | Complex synthesis, cytotoxic | Patent expiry; entry not confirmedOct 2030 | No confirmed dategeneric authorised Aug 2020 | 18 | Enquire |
| Rilpivirine hydrochloride Going generic HIV | Antiviral | Generics/biosimilars on the marketJan 2026 | Patent expiry; entry not confirmed2027 | 13 | Enquire |
| Mertansine High-potency Oncology (ADCs) | ADC payload | No confirmed datenot documented | No confirmed datenot documented | 5 | Enquire |
| Nivolumab Biosimilar substance Oncology | Monoclonal antibody | Entry expected2028 | Entry expected2030 | – | Enquire |
| Blinatumomab Biosimilar substance Haematology / Oncology | Bispecific antibody | Patent expiry; entry not confirmedApr 2030 | Patent expiry; entry not confirmedNov 2029 | – | Enquire |
| Brentuximab vedotin Biosimilar substance Oncology (Hodgkin lymphoma, ALCL) | ADC | Patent expiry; entry not confirmed2026 | Patent expiry; entry not confirmedOct 2027 | – | Enquire |
| Emicizumab Biosimilar substance Haemophilia A | Bispecific antibody | Patent expiry; entry not confirmedNov 2029 | Patent expiry; entry not confirmedFeb 2028-2029 | – | Enquire |
| Benralizumab Biosimilar substance Respiratory (severe eosinophilic asthma, EGPA) | Monoclonal antibody | Patent expiry; entry not confirmed2028-2034 | Patent expiry; entry not confirmed2025 / 2028-2034 | – | Enquire |
| Rifaximin Hard to makeGoing generic Gastroenterology | Fermentation-derived, semi-synthetic | Entry expectedJan 2028 (settlements) | No confirmed date | 18 | Enquire |
| Romiplostim Biosimilar substance Haematology | Fusion protein (peptibody) | Patent expiry; entry not confirmedFeb 2028 | Patent expiry; entry not confirmedApr 2027 | – | Enquire |
| Pertuzumab Biosimilar substance Oncology | Monoclonal antibody | Entry expectednot before 2028 | Entry expectednot before 2027 | – | Enquire |
| Axitinib Going genericHigh-potency Oncology | Kinase inhibitor | No confirmed date | No confirmed date | 7 | Enquire |
| Bosutinib Going genericHigh-potency Haematology | Kinase inhibitor | Generics/biosimilars on the marketJun 2026 | No confirmed date | 7 | Enquire |
| Exenatide Hard to makeGoing generic Diabetes | Peptide | Generics/biosimilars on the marketApr 2025 | No confirmed date | 7 | Enquire |
| Deucravacitinib Going generic Immunology | Kinase inhibitor | Patent expiry; entry not confirmed2033 | Patent expiry; entry not confirmed2033 | 14 | Enquire |
| Tenofovir alafenamide fumarate Going generic HIV, Hepatitis B | Antiviral | Patent expiry; entry not confirmed2031 | Patent expiry; entry not confirmed2027 | 26 | Enquire |
| Ferric carboxymaltose Hard to make Haematology (IDA) | Iron complex | Generics/biosimilars on the marketJul 2026 | No confirmed date | 16 | Enquire |
| Olaparib Going genericHigh-potency Oncology | PARP inhibitor | Patent expiry; entry not confirmed2027 (compound patent) | Entry expected2029 (compound patent + SPC) | 27 | Enquire |
| Palbociclib Going genericHigh-potency Oncology | Kinase inhibitor | Patent expiry; entry not confirmedMar 2027 (compound patent with PTE) | Entry expected2028 (basic patent + SPC) | 27 | Enquire |
| Ruxolitinib phosphate Going genericHigh-potency Haematology | Kinase inhibitor | Patent expiry; entry not confirmedlate 2028 | Patent expiry; entry not confirmedmid 2028 | 27 | Enquire |
| Baricitinib Going genericHigh-potency Immunology | Immunomodulator, kinase inhibitor | Patent expiry; entry not confirmed2032 (compound patent) | Patent expiry; entry not confirmed2032 (compound patent) | 7 | Enquire |
| Anidulafungin Hard to make Infectious disease (antifungal) | Semi-synthetic | No confirmed date | No confirmed date | 2 | Enquire |
| Cabozantinib s-malate Going genericHigh-potency Oncology | Kinase inhibitor | Entry expectedJan 2031 (settlements) | No confirmed date | 16 | Enquire |
| Exatecan High-potency Oncology (ADCs) | ADC payload | No confirmed date | No confirmed date | 11 | Enquire |
| Ivabradine hydrochloride Going generic Cardiovascular | Complex synthesis | Generics/biosimilars on the marketAug 2024 | No confirmed date | 10 | Enquire |
| Darolutamide High-potency Oncology (prostate) | Hormone | Patent expiry; entry not confirmedOct 2030 (earliest DS patent) | No confirmed date | 8 | Enquire |
| Cladribine Going generic Neurology | Cytotoxic | Generics/biosimilars on the marketDec 2025 | No confirmed date | 10 | Enquire |
| Zanubrutinib High-potency Haematology (CLL, lymphoma) | Kinase inhibitor | Protected beyond 2033Apr 2034 | No confirmed date | 3 | Enquire |
| Sodium ferric gluconate complex Hard to make Nephrology (IDA) | Iron complex | Generic for yearssince 2011 | No confirmed date | 3 | Enquire |
| Eribulin mesilate Hard to makeGoing genericHigh-potency Oncology (breast, liposarcoma) | Complex synthesis, cytotoxic | Generics/biosimilars on the marketMay 2024 | Generics/biosimilars on the market2024 | 19 | Enquire |
| Glatiramer acetate Hard to make Neurology (MS) | Complex polymer | Generic for yearssince 2015 | Generic for yearssince 2016-2017 | 7 | Enquire |
| Regorafenib Going genericHigh-potency Oncology (colorectal, GIST, liver) | Kinase inhibitor | Patent expiry; entry not confirmedFeb 2031 | No confirmed date | 9 | Enquire |
| Temsirolimus Hard to make Oncology (renal cell) | Semi-synthetic | Generic for yearssince 2018 | No confirmed date | 4 | Enquire |
| Doxorubicin High-potency Oncology (broad) | Cytotoxic | Generic for yearssince 1989 | Generic for years | 11 | Enquire |
| Abemaciclib Going genericHigh-potency Oncology | Kinase inhibitor | Entry expected2031 (compound patent) | Patent expiry; entry not confirmed2033 (compound patent) | 18 | Enquire |
| Fondaparinux sodium Hard to make Haematology (anticoagulant) | Complex synthesis | Generic for yearssince 2011 | No confirmed date | 13 | Enquire |
| Dolutegravir sodium Going generic HIV | Antiviral | Patent expiry; entry not confirmed2028 (compound patent); other patents to 2030 | Patent expiry; entry not confirmed2029 (compound patent + SPC) | 22 | Enquire |
| Goserelin acetate Hard to make Oncology (prostate, breast) | Peptide | No confirmed date | Generic for yearssince 2015-2016 | 5 | Enquire |
| Iloprost Hard to make Pulmonary hypertension, Frostbite | Prostaglandin | No confirmed dateJul 2026 (approval) | No confirmed date | 5 | Enquire |
| Lanreotide acetate Hard to make Endocrinology, Oncology (NET) | Peptide | Generics/biosimilars on the marketJun 2024 (first ANDA) | No confirmed date | 12 | Enquire |
| Secukinumab Biosimilar substance Immunology | Monoclonal antibody | Patent expiry; entry not confirmed2029 | Patent expiry; entry not confirmed2030 | – | Enquire |
| Daratumumab Biosimilar substance Haematology | Monoclonal antibody | Patent expiry; entry not confirmed2029 | Patent expiry; entry not confirmed2031-2032 (including SPC) | – | Enquire |
| Etanercept Biosimilar substance Immunology | Fusion protein | Entry expected2029 | Generics/biosimilars on the market2016 | – | Enquire |
| Insulin degludec Biosimilar substance Diabetes | Insulin analogue | Patent expiry; entry not confirmed2029 | Patent expiry; entry not confirmed2028 | – | Enquire |
| Evolocumab Biosimilar substance Cardiovascular | Monoclonal antibody | Patent expiry; entry not confirmedAug 2029 | Patent expiry; entry not confirmedAug 2028 | – | Enquire |
| Tezepelumab Biosimilar substance Respiratory | Monoclonal antibody | Protected beyond 2033Feb 2034 | Patent expiry; entry not confirmedSep 2028 | – | Enquire |
| Ramucirumab Biosimilar substance Oncology | Monoclonal antibody | Patent expiry; entry not confirmed2026 | Patent expiry; entry not confirmed2028 | – | Enquire |
| Atezolizumab Biosimilar substance Oncology (PD-L1) | Monoclonal antibody | Patent expiry; entry not confirmedMay 2028 | Patent expiry; entry not confirmedSep 2027-2028 | – | Enquire |
| Avelumab Biosimilar substance Oncology (urothelial, Merkel cell) | Monoclonal antibody | Patent expiry; entry not confirmedMar 2029 | Patent expiry; entry not confirmedSep 2027-2028 | – | Enquire |
| Amphotericin b Hard to make Infectious disease (fungal) | Fermentation-derived | Generic for yearsDec 2021 (liposomal) | No confirmed date | 6 | Enquire |
| Tafluprost Hard to make Ophthalmology (glaucoma) | Prostaglandin | Generics/biosimilars on the marketAug 2019 | No confirmed date | 6 | Enquire |
| Edoxaban tosylate Going generic Cardiovascular | Anticoagulant | Patent expiry; entry not confirmedApr 2027 (compound patent) | No confirmed date | 24 | Enquire |
| Iron sucrose Hard to make Nephrology, Haematology (IDA) | Iron complex | Generics/biosimilars on the marketAug 2025 | No confirmed date | 21 | Enquire |
| Octreotide acetate Hard to makeGoing generic Endocrinology, Oncology | Peptide | Generics/biosimilars on the marketOct 2024 | Generics/biosimilars on the market | 24 | Enquire |
| Canagliflozin Going generic Diabetes | SGLT2 inhibitor | Patent expiry; entry not confirmedJan 2028 (compound patent + paediatric) | No confirmed date | 25 | Enquire |
| Afatinib dimaleate Going generic Oncology | Kinase inhibitor | No confirmed date | No confirmed date | 8 | Enquire |
| Macitentan Going generic Respiratory | Endothelin antagonist | Generics/biosimilars on the marketQ2 2026 (late) | No confirmed date | 14 | Enquire |
| Liraglutide Hard to makeGoing generic Diabetes, Obesity | Peptide | Generics/biosimilars on the marketJun 2024 | No confirmed date | 24 | Enquire |
| Luspatercept Biosimilar substance Haematology | Fusion protein | Patent expiry; entry not confirmed2031 | Patent expiry; entry not confirmed2030 | – | Enquire |
| Trastuzumab deruxtecan Biosimilar substance Oncology (HER2 breast, lung, gastric) | ADC | Patent expiry; entry not confirmed2033-2035 | Patent expiry; entry not confirmed2033-2035 | – | Enquire |
| Sacituzumab govitecan Biosimilar substance Oncology (TNBC, HR+ breast) | ADC | Patent expiry; entry not confirmed2032 | Patent expiry; entry not confirmedNov 2031 | – | Enquire |
| Faricimab Biosimilar substance Ophthalmology (nAMD, DME, RVO) | Bispecific antibody | Protected beyond 2033Jan 2034 | Patent expiry; entry not confirmedSep 2032-2033 | – | Enquire |
| Pomalidomide Going genericHigh-potency Haematology | Immunomodulator, thalidomide analogue | Generics/biosimilars on the marketMar 2026 | Generics/biosimilars on the marketAug 2024-Feb 2025 (exact month not documented) | 16 | Enquire |
| Epoprostenol Hard to make Pulmonary hypertension | Prostaglandin | Generic for yearssince 2008 | Generic for years | 4 | Enquire |
| Sirolimus Hard to make Transplantation, LAM | Fermentation-derived | Generic for yearssince 2014 | No confirmed date | 13 | Enquire |
| Afatinib High-potency Oncology (lung) | Kinase inhibitor | Generics/biosimilars on the marketJul 2026 | No confirmed date | 8 | Enquire |
| Micafungin sodium Hard to make Infectious disease (antifungal) | Semi-synthetic | Generic for yearssince 2019 | No confirmed date | 10 | Enquire |
| Ibrutinib Going genericHigh-potency Haematology | Kinase inhibitor | Entry expectedMar 2032 (no entry expected before 30 Mar 2032) | No confirmed datenot documented | 24 | Enquire |
| Cetrorelix acetate Hard to make Reproductive medicine (IVF) | Peptide | Generics/biosimilars on the marketAug 2022 | No confirmed date | 11 | Enquire |
| Ganirelix acetate Hard to make Reproductive medicine (IVF) | Peptide | Generics/biosimilars on the marketNov 2018 | Generics/biosimilars on the market2022 | 9 | Enquire |
| Ustekinumab Biosimilar substance Immunology | Monoclonal antibody | Generics/biosimilars on the marketJan 2025 | Generics/biosimilars on the marketJul 2024 | – | Enquire |
| Thalidomide High-potency Haematology (myeloma), ENL | Thalidomide analogue | No confirmed datefirst generic approved 2023 | No confirmed date | 4 | Enquire |
| Triptorelin Hard to make Oncology (prostate), Gynaecology, CPP | Peptide | No confirmed date | Generic for years | 4 | Enquire |
| Glucagon Hard to make Diabetes (hypoglycaemia) | Peptide | Generics/biosimilars on the marketDec 2020 | No confirmed date | 4 | Enquire |
| Tofacitinib citrate Going genericHigh-potency Immunology | Immunomodulator, kinase inhibitor | Generics/biosimilars on the marketJun 2026 | Entry expected2028 (regulatory exclusivity) | 30 | Enquire |
| Apalutamide Going genericHigh-potency Oncology | Hormone, hormone antagonist | Patent expiry; entry not confirmedSep 2030 (compound patent) | No confirmed datenot documented | 18 | Enquire |
| Ipilimumab Biosimilar substance Oncology | Monoclonal antibody | No confirmed date | Entry expected2026 | – | Enquire |
| Romosozumab Biosimilar substance Bone | Monoclonal antibody | Patent expiry; entry not confirmedApr 2026 | Patent expiry; entry not confirmedApr 2026 | – | Enquire |
| Mepolizumab Biosimilar substance Respiratory (severe eosinophilic asthma, CRSwNP, EGPA) | Monoclonal antibody | Entry expectedNov 2027 earliest | Entry expected2028+ | – | Enquire |
| Reslizumab Biosimilar substance Respiratory (severe eosinophilic asthma) | Monoclonal antibody | Patent expiry; entry not confirmedMar 2028 | Patent expiry; entry not confirmedAug 2026 | – | Enquire |
| Belimumab Biosimilar substance Immunology (SLE, lupus nephritis) | Monoclonal antibody | Patent expiry; entry not confirmed2029-2035 | Patent expiry; entry not confirmed2026 / 2035 | – | Enquire |
| Sarilumab Biosimilar substance Immunology (rheumatoid arthritis, PMR) | Monoclonal antibody | Patent expiry; entry not confirmedMay 2029 | Patent expiry; entry not confirmedJun 2027-2028 | – | Enquire |
| Alirocumab Biosimilar substance Cardiovascular (hypercholesterolaemia) | Monoclonal antibody | Patent expiry; entry not confirmedDec 2029 | Patent expiry; entry not confirmedDec 2029 | – | Enquire |
| Dulaglutide Biosimilar substance Diabetes (GLP-1 RA) | Fusion protein | Entry expected2027 | Entry expected2029 (compound patent) | – | Enquire |
| Enzalutamide Going genericHigh-potency Oncology | Hormone, hormone antagonist | Entry expectedAug 2027 (compound patent) | Entry expected2028 | 31 | Enquire |
| Caspofungin acetate Hard to make Infectious disease (antifungal) | Semi-synthetic | Generic for yearssince 2017 | Generic for yearssince 2016 | 9 | Enquire |
| Estradiol High-potency Women's health (HRT) | Hormone | Generic for years | Generic for years | 25 | Enquire |
| Nilotinib Going genericHigh-potency Haematology | Kinase inhibitor | Generics/biosimilars on the marketMay 2025 | Generics/biosimilars on the market2025 | 22 | Enquire |
| Vortioxetine hydrobromide Going generic Psychiatry | Antidepressant | Entry expectedDec 2031 (earliest, per patent database) | Patent expiry; entry not confirmedApr 2028 (SPC + paediatric) | 29 | Enquire |
| Enoxaparin sodium Hard to make Haematology (anticoagulant) | Heparin-type | Generic for yearssince 2010 | Generic for yearssince 2016 | 14 | Enquire |
| Apremilast Going generic Immunology | PDE4 inhibitor | Entry expectedFeb 2028 | No confirmed date | 33 | Enquire |
| Everolimus Hard to makeHigh-potency Oncology / transplant | MTOR inhibitor, semi-synthetic | Generic for yearssince 2018 | Generic for years | 19 | Enquire |
| Natalizumab Biosimilar substance Neurology | Monoclonal antibody | Generics/biosimilars on the marketNov 2025 | Generics/biosimilars on the marketJan 2024 | – | Enquire |
| Upadacitinib High-potency Immunology (RA, IBD, AD) | Immunomodulator | Protected beyond 2033Apr 2037 | No confirmed date | 17 | Enquire |
| Docetaxel High-potency Oncology (breast, prostate, lung) | Cytotoxic | Generic for yearssince 2011 | Generic for yearssince 2012 | 20 | Enquire |
| Daptomycin Hard to make Infectious disease (Gram-positive) | Fermentation-derived | Generic for yearssince 2016 | Generic for yearssince 2017 | 12 | Enquire |
| Vedolizumab Biosimilar substance Gastroenterology | Monoclonal antibody | Patent expiry; entry not confirmed2032 (formulation, dosing patents) | Patent expiry; entry not confirmed2032 (formulation, dosing patents) | – | Enquire |
| Dupilumab Biosimilar substance Immunology / Dermatology | Monoclonal antibody | Patent expiry; entry not confirmedMar 2031 | Patent expiry; entry not confirmedMar 2033 (SPC incl. paediatric extension) | – | Enquire |
| Ixekizumab Biosimilar substance Immunology | Monoclonal antibody | Patent expiry; entry not confirmed2030 | Patent expiry; entry not confirmed2031 | – | Enquire |
| Risankizumab Biosimilar substance Immunology | Monoclonal antibody | Patent expiry; entry not confirmed2033 | No confirmed date | – | Enquire |
| Guselkumab Biosimilar substance Immunology | Monoclonal antibody | Patent expiry; entry not confirmed2031 | No confirmed date | – | Enquire |
| Durvalumab Biosimilar substance Oncology (PD-L1) | Monoclonal antibody | Patent expiry; entry not confirmed2031 | Patent expiry; entry not confirmed2030 | – | Enquire |
| Ofatumumab Biosimilar substance Multiple sclerosis (formerly CLL) | Monoclonal antibody | Patent expiry; entry not confirmed2031 | No confirmed date | – | Enquire |
| Gadobutrol Hard to make Radiology (MRI) | Contrast agent | No confirmed dateNov 2022 (approval) | No confirmed date | 9 | Enquire |
| Agalsidase beta Biosimilar substance Rare disease (Fabry) | Enzyme | No confirmed date | No confirmed date | – | Enquire |
| Letrozole High-potency Oncology (breast) | Hormone | Generic for years | Generic for years | 13 | Enquire |
| Sorafenib High-potency Oncology (liver, renal, thyroid) | Kinase inhibitor | No confirmed datefirst generic approved Sep 2020 | No confirmed dategeneric authorised Nov 2022 | 17 | Enquire |
| Fulvestrant High-potency Oncology (breast) | Hormone | Generic for yearssince 2019 | Generic for yearssince 2018 | 13 | Enquire |
| Eltrombopag olamine Going generic Haematology | Thrombopoietin agonist | Generics/biosimilars on the marketMay 2025 | Generics/biosimilars on the marketQ3 2025 | 25 | Enquire |
| Icatibant acetate Hard to make Hereditary angioedema | Peptide | Generics/biosimilars on the marketJul 2019 | Generics/biosimilars on the market2021 | 16 | Enquire |
| Bivalirudin Hard to make Cardiology (anticoagulant) | Peptide | Generic for yearssince 2015 | No confirmed date | 11 | Enquire |
| Tolvaptan Going generic Nephrology | Vasopressin antagonist | Generics/biosimilars on the marketMay 2025 | No confirmed date | 18 | Enquire |
| Cisplatin High-potency Oncology (broad) | Cytotoxic | Generic for yearssince 1999 | Generic for years | 6 | Enquire |
| Tirzepatide Hard to make Diabetes, Obesity | Peptide | Protected beyond 2033May 2036 (compound patent) | Protected beyond 20332036+ (est.) | 42 | Enquire |
| Treprostinil Hard to make Pulmonary hypertension | Prostaglandin | Generic for yearssince 2017 (first ANDA approval) | No confirmed date | 20 | Enquire |
| Bendamustine High-potency Haematology (CLL, lymphoma) | Cytotoxic | No confirmed datefirst generic approved Dec 2022 | Generic for years | 19 | Enquire |
| Tocilizumab Biosimilar substance Immunology | Monoclonal antibody | Generics/biosimilars on the marketApr 2024 | No confirmed dateSep 2023 (authorised) | – | Enquire |
| Pazopanib High-potency Oncology (renal, sarcoma) | Kinase inhibitor | Generics/biosimilars on the marketOct 2023 | No confirmed date | 13 | Enquire |
| Sugammadex sodium Hard to makeGoing generic Anaesthesia | Complex synthesis | Generics/biosimilars on the marketJul 2026 | Generics/biosimilars on the market2023 | 29 | Enquire |
| Trastuzumab emtansine Biosimilar substance Oncology | Antibody-drug conjugate | No confirmed datenot documented | No confirmed datenot documented | – | Enquire |
| Abatacept Biosimilar substance Immunology | Fusion protein | No confirmed date | No confirmed date | – | Enquire |
| Cetuximab Biosimilar substance Oncology (colorectal, head and neck) | Monoclonal antibody | No confirmed date | No confirmed date | – | Enquire |
| Obinutuzumab Biosimilar substance Oncology (CLL, follicular lymphoma); lupus nephritis | Monoclonal antibody | No confirmed date | No confirmed date | – | Enquire |
| Eptacog alfa (activated) Biosimilar substance Haematology (haemophilia with inhibitors, FVII deficiency) | Coagulation factor | No confirmed date | No confirmed date | – | Enquire |
| Octocog alfa Biosimilar substance Haematology (haemophilia A) | Coagulation factor | No confirmed date | No confirmed date | – | Enquire |
| Idursulfase Biosimilar substance Rare disease (MPS II, Hunter syndrome) | Enzyme | No confirmed date | No confirmed date | – | Enquire |
| Alglucosidase alfa Biosimilar substance Rare disease (Pompe disease) | Enzyme | No confirmed date | No confirmed date | – | Enquire |
| Sevelamer carbonate Hard to make Nephrology (hyperphosphataemia) | Complex polymer | Generic for yearssince 2017 | No confirmed date | 14 | Enquire |
| Bimatoprost Hard to make Ophthalmology (glaucoma), Aesthetics | Prostaglandin | Generic for yearssince 2014-2015 | No confirmed date | 14 | Enquire |
| Travoprost Hard to make Ophthalmology (glaucoma) | Prostaglandin | Generic for yearssince 2013 | No confirmed date | 14 | Enquire |
| Dasatinib Going genericHigh-potency Haematology | Kinase inhibitor | Generics/biosimilars on the marketSep 2024 | Generics/biosimilars on the market | 30 | Enquire |
| Raltegravir potassium Going generic HIV | Antiviral | No confirmed date | No confirmed date | 6 | Enquire |
| Prucalopride succinate Going generic Gastroenterology | 5-HT4 agonist | Generics/biosimilars on the marketJan 2025 | No confirmed date | 13 | Enquire |
| Ocrelizumab Biosimilar substance Neurology | Monoclonal antibody | No confirmed datenot documented | No confirmed datenot documented | – | Enquire |
| Exemestane High-potency Oncology (breast) | Hormone | Generic for yearssince 2011 | Generic for years | 10 | Enquire |
| Tigecycline Hard to make Infectious disease | Semi-synthetic | Generic for yearssince 2015 | Generic for yearssince 2020 | 10 | Enquire |
| Teriparatide Biosimilar substanceHard to make Osteoporosis | Peptide, peptide hormone (recombinant) | Generics/biosimilars on the market2019 (505(b)(2)); Nov 2023 (ANDA) | Generics/biosimilars on the market2017 | – | Enquire |
| Aflibercept Biosimilar substance Ophthalmology | Fusion protein | Generics/biosimilars on the marketOct 2024 | Generics/biosimilars on the marketDec 2025 | – | Enquire |
| Denosumab Biosimilar substance Bone / Oncology | Monoclonal antibody | Generics/biosimilars on the marketJun 2025 | Generics/biosimilars on the marketDec 2025 | – | Enquire |
| Omalizumab Biosimilar substance Respiratory / Allergy | Monoclonal antibody | Generics/biosimilars on the marketOct 2026 | Generics/biosimilars on the market2025 (by Nov 2025) | – | Enquire |
| Golimumab Biosimilar substance Immunology | Monoclonal antibody | No confirmed date | Generics/biosimilars on the marketDec 2025 | – | Enquire |
| Eculizumab Biosimilar substance Rare disease (haematology) | Monoclonal antibody | Generics/biosimilars on the marketApr 2025 | No confirmed date2023 (authorised) | – | Enquire |
| Azacitidine High-potency Haematology (MDS, AML) | Cytotoxic | Generic for yearssince 2013 | Generic for yearssince 2020 | 19 | Enquire |
| Infliximab Biosimilar substance Immunology / Gastroenterology | Monoclonal antibody | Generics/biosimilars on the marketNov 2016 | Generics/biosimilars on the marketFeb 2015 | – | Enquire |
| Eptifibatide Hard to make Cardiology (antiplatelet) | Peptide | Generic for yearssince 2015 | Generic for yearssince 2016 | 12 | Enquire |
| Tralokinumab Biosimilar substance Dermatology (atopic dermatitis) | Monoclonal antibody | Patent expiry; entry not confirmedDec 2033 | Patent expiry; entry not confirmedJun 2031-2032 | – | Enquire |
| Erenumab Biosimilar substance Neurology (migraine prevention) | Monoclonal antibody | Patent expiry; entry not confirmedMay 2032 | Patent expiry; entry not confirmed2033 | – | Enquire |
| Fremanezumab Biosimilar substance Neurology (migraine prevention) | Monoclonal antibody | Patent expiry; entry not confirmed2031 | Patent expiry; entry not confirmed2031 | – | Enquire |
| Galcanezumab Biosimilar substance Neurology (migraine, cluster headache) | Monoclonal antibody | Patent expiry; entry not confirmed2033 | Patent expiry; entry not confirmed2033 | – | Enquire |
| Brolucizumab Biosimilar substance Ophthalmology (nAMD, DME) | Antibody fragment | Patent expiry; entry not confirmedOct 2031 | Patent expiry; entry not confirmedFeb 2030-2031 | – | Enquire |
| Asparaginase Biosimilar substance Oncology (ALL) | Enzyme | Patent expiry; entry not confirmedJun 2033 | No confirmed date | – | Enquire |
| Follitropin alfa Biosimilar substance Fertility | Glycoprotein hormone | No confirmed date | Generics/biosimilars on the marketsince 2013 | – | Enquire |
| Vasopressin Hard to make Critical care (vasodilatory shock) | Peptide | Generics/biosimilars on the marketDec 2021 | No confirmed date | 9 | Enquire |
| Nintedanib esilate Going generic Respiratory | Kinase inhibitor | Generics/biosimilars on the marketApr 2026 | No confirmed date | 25 | Enquire |
| Tacrolimus Hard to make Transplantation, Dermatology | Fermentation-derived | Generic for yearssince 2009 | Generic for yearssince 2017 (central) | 22 | Enquire |
| Lenalidomide Going genericHigh-potency Haematology | Immunomodulator, thalidomide analogue | Generics/biosimilars on the marketMar 2022 | Generics/biosimilars on the marketFeb 2022 | 24 | Enquire |
| Bortezomib High-potency Haematology (myeloma) | Cytotoxic | Generics/biosimilars on the market2022 | Generic for years | 24 | Enquire |
| Cyclophosphamide High-potency Oncology / immunology | Cytotoxic | Generic for yearssince 1982 | Generic for years | 15 | Enquire |
| Ciclosporin Hard to make Transplantation, Ophthalmology | Fermentation-derived | Generic for yearssince 1999 | Generic for years | 15 | Enquire |
| Semaglutide Hard to makeGoing generic Diabetes, Obesity | Peptide | Entry expected2032 (compound patent) | Patent expiry; entry not confirmedMar 2031 (compound patent + SPC) | 84 | Enquire |
| Insulin glargine Biosimilar substance Diabetes | Insulin analogue | Generics/biosimilars on the marketNov 2021 | Generics/biosimilars on the marketSep 2015 | – | Enquire |
| Sunitinib High-potency Oncology (renal, GIST) | Kinase inhibitor | Generics/biosimilars on the marketAug 2021 | Generics/biosimilars on the market2021 | 9 | Enquire |
| Oxaliplatin High-potency Oncology (colorectal) | Cytotoxic | Generic for yearssince 2009 | Generic for years | 16 | Enquire |
| Temozolomide High-potency Oncology (glioma) | Cytotoxic | Generic for yearssince 2010 | Generic for yearssince 2010 | 16 | Enquire |
| Leuprorelin acetate Hard to make Oncology (prostate), Gynaecology | Peptide | Generic for yearssince 1998 | Generic for years | 16 | Enquire |
| Sacubitril + valsartan Going generic Cardiovascular | Complex synthesis | Generics/biosimilars on the marketJul 2025 | Entry expectedNov 2026 (regulatory data protection) | 47 | Enquire |
| Certolizumab pegol Biosimilar substance Immunology | PEGylated antibody fragment | No confirmed date | No confirmed date | – | Enquire |
| Panitumumab Biosimilar substance Oncology (colorectal) | Monoclonal antibody | No confirmed date | No confirmed date | – | Enquire |
| Belatacept Biosimilar substance Transplantation (kidney) | Fusion protein | No confirmed date | No confirmed date | – | Enquire |
| Darbepoetin alfa Biosimilar substance Nephrology/oncology (anaemia) | Growth factor | No confirmed date | No confirmed date | – | Enquire |
| Methoxy polyethylene glycol-epoetin beta Biosimilar substance Nephrology (CKD anaemia) | Growth factor (PEGylated) | No confirmed date | No confirmed date | – | Enquire |
| Interferon beta-1a Biosimilar substance Multiple sclerosis | Cytokine | No confirmed date | No confirmed date | – | Enquire |
| Peginterferon alfa-2a Biosimilar substance Hepatology (HBV); haematology (MPN, off-label) | Cytokine (PEGylated) | No confirmed date | No confirmed date | – | Enquire |
| Alteplase Biosimilar substance Cardiovascular/stroke (thrombolysis) | Enzyme (thrombolytic) | No confirmed date | No confirmed date | – | Enquire |
| Tenecteplase Biosimilar substance Cardiovascular/stroke (thrombolysis) | Enzyme (thrombolytic) | No confirmed date | No confirmed date | – | Enquire |
| Nonacog alfa Biosimilar substance Haematology (haemophilia B) | Coagulation factor | No confirmed date | No confirmed date | – | Enquire |
| Laronidase Biosimilar substance Rare disease (MPS I) | Enzyme | No confirmed date | No confirmed date | – | Enquire |
| Imiglucerase Biosimilar substance Rare disease (Gaucher type 1) | Enzyme | No confirmed date | No confirmed date | – | Enquire |
| Pegaspargase Biosimilar substance Oncology (ALL) | Enzyme (PEGylated) | No confirmed date | No confirmed date | – | Enquire |
| Collagenase clostridium histolyticum Biosimilar substance Dupuytren's contracture, Peyronie's disease | Enzyme | Protected beyond 2033late 2030s | No confirmed date | – | Enquire |
| Bicalutamide High-potency Oncology (prostate) | Hormone | Generic for yearssince 2009 | Generic for years | 9 | Enquire |
| Decitabine High-potency Haematology (MDS, AML) | Cytotoxic | Generic for yearssince 2013 | Generic for years | 18 | Enquire |
| Latanoprost Hard to make Ophthalmology (glaucoma) | Prostaglandin | Generic for yearssince 2011 | Generic for yearssince 2012 | 18 | Enquire |
| Tafamidis meglumine Going generic Rare disease | Rare disease | Entry expectedJun 2031 (settlements) | Entry expectedFeb 2030 (orphan exclusivity, ATTR-CM) | 29 | Enquire |
| Gemcitabine High-potency Oncology (pancreas, lung, bladder) | Cytotoxic | Generic for yearssince 2010 | Generic for years | 17 | Enquire |
| Fingolimod High-potency Neurology (MS) | Immunomodulator | Generic for yearssince 2019 | Generic for yearssince 2020 | 19 | Enquire |
| Ticagrelor Going generic Cardiovascular | Antiplatelet | Generics/biosimilars on the marketQ2 2025 | Generics/biosimilars on the marketQ2 2025 | 40 | Enquire |
| Paclitaxel High-potency Oncology (breast, ovarian, lung) | Cytotoxic | Generic for yearssince 2002 | Generic for years | 28 | Enquire |
| Empagliflozin Going generic Diabetes, Cardiorenal | SGLT2 inhibitor | Entry expected2029 (compound patent) | Entry expected2029 (compound patent) | 54 | Enquire |
| Erlotinib High-potency Oncology (lung) | Kinase inhibitor | Generic for yearssince 2014-2015 | Generic for years | 18 | Enquire |
| Mupirocin Hard to make Dermatology, Infection | Fermentation-derived | Generic for yearssince 2003 | Generic for years | 20 | Enquire |
| Adalimumab Biosimilar substance Immunology | Monoclonal antibody | Generics/biosimilars on the marketJan 2023 | Generics/biosimilars on the marketOct 2018 | – | Enquire |
| Rituximab Biosimilar substance Oncology / Immunology | Monoclonal antibody | Generics/biosimilars on the marketNov 2019 | Generics/biosimilars on the market2017 | – | Enquire |
| Trastuzumab Biosimilar substance Oncology | Monoclonal antibody | Generics/biosimilars on the marketJul 2019 | Generics/biosimilars on the market2018 | – | Enquire |
| Bevacizumab Biosimilar substance Oncology / Ophthalmology | Monoclonal antibody | Generics/biosimilars on the marketJul 2019 | Generics/biosimilars on the marketJun 2020 | – | Enquire |
| Epoetin alfa Biosimilar substance Nephrology / Oncology supportive care | Growth factor | Generics/biosimilars on the marketNov 2018 | Generics/biosimilars on the marketsince 2007 | – | Enquire |
| Gefitinib High-potency Oncology (lung) | Kinase inhibitor | Generics/biosimilars on the marketSep 2022 | Generic for years | 14 | Enquire |
| Capecitabine High-potency Oncology (colorectal, breast) | Cytotoxic | Generic for yearssince 2013 | Generic for yearssince 2012 | 17 | Enquire |
| Anastrozole High-potency Oncology (breast) | Hormone | Generic for yearssince 2010 | Generic for years | 14 | Enquire |
| Cemiplimab Biosimilar substance Oncology (PD-1) | Monoclonal antibody | Protected beyond 2033Sep 2035 | Protected beyond 2033Jan 2035 | – | Enquire |
| Dostarlimab Biosimilar substance Oncology (PD-1, endometrial/dMMR) | Monoclonal antibody | Protected beyond 20332035 | Protected beyond 20332036 | – | Enquire |
| Ravulizumab Biosimilar substance Rare disease (PNH, aHUS, gMG, NMOSD) | Monoclonal antibody | Protected beyond 20332035 | Protected beyond 20332035 | – | Enquire |
| Insulin aspart Biosimilar substance Diabetes | Insulin analogue | No confirmed dateapproved Feb 2025 | No confirmed dateauthorised Jun 2020 | – | Enquire |
| Insulin lispro Biosimilar substance Diabetes | Insulin analogue | Generics/biosimilars on the market2018 | No confirmed dateauthorised Jul 2017 | – | Enquire |
| Somatropin Biosimilar substance Endocrinology | Growth hormone | Generics/biosimilars on the marketsince 2006 | Generics/biosimilars on the marketsince 2006 | – | Enquire |
| Alemtuzumab Biosimilar substance Multiple sclerosis; CLL | Monoclonal antibody | No confirmed date | No confirmed date | – | Enquire |
| Palivizumab Biosimilar substance RSV prophylaxis (infants) | Monoclonal antibody | No confirmed date | No confirmed date | – | Enquire |
| Canakinumab Biosimilar substance Immunology (periodic fever syndromes, Still's disease) | Monoclonal antibody | No confirmed date | No confirmed date | – | Enquire |
| Basiliximab Biosimilar substance Transplantation (induction) | Monoclonal antibody | No confirmed date | No confirmed date | – | Enquire |
| Insulin detemir Biosimilar substance Diabetes | Insulin analogue | No confirmed date | No confirmed date | – | Enquire |
| Insulin glulisine Biosimilar substance Diabetes | Insulin analogue | No confirmed date | No confirmed date | – | Enquire |
| Ziv-aflibercept Biosimilar substance Oncology (metastatic colorectal) | Fusion protein | No confirmed date | No confirmed date | – | Enquire |
| Rasburicase Biosimilar substance Oncology supportive care (tumour lysis) | Enzyme | No confirmed date | No confirmed date | – | Enquire |
| Apixaban Going generic Cardiovascular | Anticoagulant | Entry expectedApr 2028 | Entry expectedNov 2026 (compound patent + SPC) | 57 | Enquire |
| Mirabegron Going generic Urology | Beta-3 agonist | Generics/biosimilars on the marketApr 2024 | No confirmed date | 38 | Enquire |
| Abiraterone acetate High-potency Oncology (prostate) | Hormone | Generic for yearssince 2018 | Generic for yearssince 2021 | 27 | Enquire |
| Dapagliflozin Going generic Diabetes, Cardiorenal | SGLT2 inhibitor | Generics/biosimilars on the marketQ2 2026 | Entry expected2028 (compound patent + SPC) | 68 | Enquire |
| Ranibizumab Biosimilar substance Ophthalmology | Monoclonal antibody fragment | Generics/biosimilars on the marketJul 2022 | Generics/biosimilars on the market2023 (at latest) | – | Enquire |
| Filgrastim Biosimilar substance Oncology supportive care | Growth factor | Generics/biosimilars on the marketSep 2015 | Generics/biosimilars on the marketsince 2008 | – | Enquire |
| Pegfilgrastim Biosimilar substance Oncology supportive care | Growth factor | Generics/biosimilars on the marketJul 2018 | Generics/biosimilars on the market2018 | – | Enquire |
| Pemetrexed High-potency Oncology (lung, mesothelioma) | Cytotoxic | Generics/biosimilars on the marketMay 2022 | Generic for yearssince 2015 | 30 | Enquire |
| Linagliptin Going generic Diabetes | DPP-4 inhibitor | No confirmed date | No confirmed date | 36 | Enquire |
| Imatinib High-potency Haematology (CML, GIST) | Kinase inhibitor | Generic for yearssince 2016 | Generic for yearssince 2013 | 25 | Enquire |
| Insulin human Biosimilar substance Diabetes | Insulin (human) | No confirmed date | No confirmed date | – | Enquire |
| Sitagliptin phosphate Going generic Diabetes | DPP-4 inhibitor | Generics/biosimilars on the marketMay 2026 | Generics/biosimilars on the marketSep 2022 | 76 | Enquire |
| Rivaroxaban Going generic Cardiovascular | Anticoagulant | Generics/biosimilars on the marketMar 2025 | Generics/biosimilars on the market2024 | 64 | Enquire |
| Human albumin 4-5% Plasma-derived Volume replacement / critical care | Albumin | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human albumin 20-25% Plasma-derived Hepatology / critical care | Albumin | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human normal immunoglobulin (intravenous) Plasma-derived Immunology / neurology | Immunoglobulin | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human normal immunoglobulin (subcutaneous) Plasma-derived Primary immunodeficiency / CIDP | Immunoglobulin | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human normal immunoglobulin (intramuscular) Plasma-derived Infectious disease prophylaxis (hepatitis A, measles) | Immunoglobulin | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human anti-d (rho(d)) immunoglobulin Plasma-derived Obstetrics / haemolytic disease of the foetus and newborn | Hyperimmune | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human hepatitis b immunoglobulin Plasma-derived Hepatology / transplantation / neonatal prophylaxis | Hyperimmune | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human rabies immunoglobulin Plasma-derived Infectious disease (post-exposure prophylaxis) | Hyperimmune | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human tetanus immunoglobulin Plasma-derived Infectious disease / emergency medicine | Hyperimmune | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human cytomegalovirus immunoglobulin Plasma-derived Transplantation / infectious disease | Hyperimmune | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human varicella-zoster immunoglobulin Plasma-derived Infectious disease (post-exposure prophylaxis) | Hyperimmune | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human coagulation factor viii (plasma-derived) Plasma-derived Haemophilia A | Coagulation factor | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human von willebrand factor / coagulation factor viii complex Plasma-derived Von Willebrand disease / haemophilia A | Coagulation factor | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human coagulation factor ix (plasma-derived) Plasma-derived Haemophilia B | Coagulation factor | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human prothrombin complex concentrate (4-factor) Plasma-derived Anticoagulant reversal / haemorrhage | Coagulation factor | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human prothrombin complex concentrate (3-factor) / factor ix complex Plasma-derived Haemophilia B / anticoagulant reversal (off-label) | Coagulation factor | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human fibrinogen concentrate Plasma-derived Congenital fibrinogen deficiency / acquired bleeding | Coagulation factor | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human coagulation factor vii (plasma-derived) Plasma-derived Congenital factor VII deficiency | Coagulation factor | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human coagulation factor xiii concentrate Plasma-derived Congenital factor XIII deficiency | Coagulation factor | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human coagulation factor x Plasma-derived Congenital factor X deficiency | Coagulation factor | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human antithrombin Plasma-derived Hereditary antithrombin deficiency | Protease inhibitor | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human protein c concentrate Plasma-derived Congenital protein C deficiency / purpura fulminans | Protease inhibitor | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human c1-esterase inhibitor Plasma-derived Hereditary angioedema | Protease inhibitor | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human alpha-1 proteinase inhibitor Plasma-derived Alpha-1 antitrypsin deficiency (emphysema) | Protease inhibitor | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Fibrin sealant (human fibrinogen / human thrombin) Plasma-derived Surgery | Haemostat | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human thrombin (topical) Plasma-derived Surgery | Haemostat | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Activated prothrombin complex concentrate (anti-inhibitor coagulant complex) Plasma-derived Haemophilia A/B with inhibitors | Coagulation factor | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human plasma (pooled and treated for virus inactivation) Plasma-derived Transfusion (pooled solvent/detergent plasma) | Plasma product | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Human plasminogen Plasma-derived Congenital plasminogen deficiency (type 1) | Protease zymogen | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Source plasma (plasmapheresis plasma for fractionation) Plasma-derived Starting material for fractionation | Raw material | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Recovered plasma (from whole blood) Plasma-derived Starting material for fractionation | Raw material | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Cryoprecipitate / cryo-paste (fractionation intermediate) Plasma-derived Intermediate for FVIII, VWF and fibrinogen | Intermediate | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Cohn fraction ii+iii / igg paste (fractionation intermediate) Plasma-derived Intermediate for immunoglobulins | Intermediate | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Cohn fraction v / albumin paste (fractionation intermediate) Plasma-derived Intermediate for albumin | Intermediate | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
| Contract (toll) fractionation service Plasma-derived Manufacturing service for national plasma programmes | Service | Plasma product (no patent-driven entry) | Plasma Master File rules apply | – | Enquire |
"US DMFs" counts active Type II API Drug Master Files on the FDA list (third quarter 2026); a dash means not applicable, as with biologics and plasma products. Entry dates come from originator filings, FDA and EMA records and trade press, checked in October 2026; see our generic and biosimilar entry tracker for sources on the main molecules.
How sourcing works
- Tell us what you need: molecule, grade, quantity, the market you will file in and whether you need samples.
- We shortlist suppliers that hold the right files for your market (US DMF, CEP or EU ASMF, written confirmation where needed) and check their GMP certificates.
- You receive matched offers with documents. Contact details are shared only when both sides agree.
Questions
What counts as a specialty API?
We focus on active ingredients that are harder to make or handle than everyday generics: high-potency molecules that need containment, peptides, fermentation products, complex mixtures such as iron complexes, APIs for medicines about to lose patent protection, and biologic drug substances. Fewer companies can supply them, which is why the right introduction matters.
What does the US DMF count tell me?
It is the number of active Type II API Drug Master Files on the FDA list for that molecule. A low number usually means fewer qualified sources and firmer prices; a high number means plenty of choice. It does not prove that a particular site is GMP-compliant today, so we still check documents before we introduce a supplier.
Can I buy small quantities for development?
Yes. Many enquiries are for development or validation batches. Tell us the quantity, grade and the market you plan to file in, and we will look for suppliers who can provide samples with the right documents.
Do you make one of these APIs?
List it with us free of charge. Once we have checked your GMP certificate and regulatory files, we send you matched enquiries with the volume, grade and target market. Your company name stays private unless you choose otherwise.
List your APIBrand names are trademarks of their respective owners and are shown only to identify the reference medicine. Supply of any medicine or ingredient depends on the buyer's and supplier's licences and on the rules of the importing country; controlled substances are not handled through this page.
