Generic and Biosimilar Entry Tracker 2026–2032
By the PharmaTradz BD Team · Updated 16 October 2026 · Next full review January 2027
When can generics or biosimilars of today's highest-value medicines be sold in the United States and the European Union? This table answers that for 45 molecules, market by market, and shows the evidence behind every date.
We keep three things apart that often get mixed up: copies that are already on the market, entry dates that are agreed or expected, and patent expiries that may or may not open the market. Each date comes from the originator's own filings, FDA or EMA records, court decisions or trade press, and is linked so you can check it.
19on the US market
14on the EU market or authorised
23market entries expected
4markets protected beyond 2032
45 of 45 medicines shown · Download the data (CSV)
| Medicine | United States | European Union |
|---|---|---|
| Sugammadex Bridion Anaesthesia · small molecule EU first launch month not documented; the originator lists EU patents expired. | On the market Jul 2026 Originator's 10-K: US patent protection to 2026 plus six-month paediatric exclusivity eligibility; first generics launched 28 July 2026. Company filing | On the market 2023 Generics authorised EU-wide June 2023; the originator reported Q4 2023 sales decline from generic competition in Europe. Company filing |
| Denosumab Prolia, Xgeva Bone · biologic Multiple biosimilars launched in both markets within months. | On the market Jun 2025 First US biosimilars (both Prolia and Xgeva references) became available on 2 June 2025 following patent settlements. GaBI Online | On the market Dec 2025 Originator patents expired 27 November 2025; first EU biosimilar launches announced at the start of December 2025. Center for Biosimilars |
| Apixaban Eliquis Cardiovascular · small molecule Originator reports at-risk generics already marketed in some EU countries during litigation; UK SPC invalidated. | Entry expected Apr 2028 Originator's 2025 10-K: settlements allow generic launch in 2028; trade press reports exclusivity to 1 April 2028 after appeal wins. Company filingFierce Pharma | Entry expected Nov 2026 (compound patent + SPC) Originator's 2025 10-K: EU composition-of-matter patents and related SPCs expire November 2026; the co-marketing partner's 2025 10-K also lists EU expiry 2026. Company filingCompany filing (2) |
| Edoxaban Savaysa, Lixiana Cardiovascular · small molecule Originator cites Lixiana patent expiry as a challenge to FY2030 without giving regional dates. | Patent expiry, entry not confirmed Apr 2027 (compound patent) FDA Orange Book lists compound patent to 18 April 2027 and formulation patent to 28 March 2028; no generic approved. FDA Orange BookDrugs.com | No confirmed date No originator or regulator statement of the EU compound patent/SPC expiry or generic entry date was found. |
| Rivaroxaban Xarelto Cardiovascular · small molecule US once-daily dosing patent litigation dismissed Dec 2025-Jan 2026 (Originator's 10-K); EU dosing patent ran to Jan 2026. | On the market Mar 2025 FDA approved first generics (2.5 mg) on 3 March 2025 and 10/15/20 mg strengths on 14 May 2025. FDADrugs.com | On the market 2024 Compound patent SPC expired in Europe in April 2024; the originator reported loss of exclusivity in most geographies during 2024. JUVE PatentFierce Pharma |
| Sacubitril + valsartan Entresto Cardiovascular · small molecule Originator may assert later-expiring patents in Europe; entry could vary by country. | On the market Jul 2025 Originator's 2025 annual report: lost US market exclusivity for Entresto in July 2025; FDA approved first generics May 2024. Company filingFDA | Entry expected Nov 2026 (regulatory data protection) Originator's 2025 annual report: regulatory data protection for Entresto in Europe expires November 2026. Company filing |
| Ticagrelor Brilinta, Brilique Cardiovascular · small molecule Originator lists later US patents to 2030-2036 and EU patent to 2037. | On the market Q2 2025 Originator's FY2025 results: Brilinta decline driven by generic entry in the US in Q2 2025; compound patent expired 2025. Company filingCompany filing (2) | On the market Q2 2025 Originator's FY2025 results: generic entry in Europe in Q2 2025; patent table lists EU compound patent expiry 2025. Company filingCompany filing (2) |
| Dapagliflozin Farxiga, Forxiga Diabetes · small molecule First US generics labelled for type 2 diabetes uses only; UK generics since Q3 2025; SPC dates vary by country. | On the market Q2 2026 FDA approved first generics on 6 April 2026; the originator reports multiple generics launched in the US in Q2 2026. Company filingFDA | Entry expected 2028 (compound patent + SPC) Originator's 2025 patent expiry table lists the new molecular entity patent in major EU markets expiring 2028. Company filingCompany filing (2) |
| Dulaglutide Trulicity Diabetes · biologic No biosimilar approval found in either market. | Entry expected 2027 Originator's 2025 10-K lists US compound patent and biologics data protection both expiring 2027. Company filing | Entry expected 2029 (compound patent) Originator's 2025 10-K lists compound patent expiry in major European countries in 2029. Company filing |
| Empagliflozin Jardiance Diabetes · small molecule Further US method-of-use patents listed to 2034; the product is marketed under a two-company alliance. | Entry expected 2029 (compound patent) Originator's 2025 10-K lists US compound patent expiry 2029; Orange Book shows August 2028 plus paediatric exclusivity to February 2029. Company filingFDA Orange Book | Entry expected 2029 (compound patent) Originator's 2025 10-K lists compound patent expiry in major European countries in 2029. Company filing |
| Linagliptin Tradjenta, Trajenta Diabetes · small molecule The originator is privately held and publishes no patent expiry table. | No confirmed date FDA-approved generics are not marketed; Orange Book lists formulation patents to 2027-2031; entry terms undisclosed. FDA Orange BookDrugs.com | No confirmed date No originator statement of EU SPC expiry or generic entry found; Trajenta EU authorisation dates from August 2011. EMA |
| Sitagliptin Januvia Diabetes · small molecule Originator noted Janumet retained exclusivity in certain European markets in late 2022. | On the market May 2026 Originator's Q2 2026 10-Q: under salt-patent settlements, Januvia and Janumet lost US exclusivity May 2026; Janumet XR July 2026. Company filingCompany filing (2) | On the market Sep 2022 Originator's Q3 2022 earnings release: lost market exclusivity for Januvia and Janumet in the EU in September 2022. Company filingCompany filing (2) |
| Liraglutide Victoza, Saxenda Diabetes, Obesity · peptide Peptide; US follow-ons are ANDA generics. First generic Saxenda approved by FDA August 2025. | On the market Jun 2024 Originator's 2025 20-F: settled makers licensed to sell generic Victoza from 22 June 2024; first ANDA generic launched December 2024. Company filingFDA | No confirmed date Originator reports the compound patent expired in Germany in 2023; first EU generic launch month not documented. Company filing |
| Semaglutide Ozempic, Wegovy, Rybelsus Diabetes, Obesity · peptide Peptide regulated as a drug, so follow-ons would be generics. Oral tablet patents run 2031-2034. | Entry expected 2032 (compound patent) Originator's 2025 20-F states US compound patent expiry 2032; Orange Book lists the compound patent to December 2031. Company filingFDA Orange Book | Patent expiry, entry not confirmed Mar 2031 (compound patent + SPC) Patent attorney analyses report SPCs on the semaglutide compound patent extend EU protection to March 2031. Abel + ImrayReddie & Grose |
| Bictegravir + emtricitabine + tenofovir alafenamide Biktarvy HIV · small molecule | Protected beyond 2032 Apr 2036 (settlements) Originator's 2025 10-K: October 2025 settlements mean no US generic entry expected before 1 April 2036, subject to acceleration clauses. Company filingFierce Pharma | Protected beyond 2032 2033 Originator's 2025 10-K lists EU patent expiry 2033 for Biktarvy. Company filing |
| Dolutegravir Tivicay, Triumeq, Juluca, Dovato HIV · small molecule Combination products carry later patents (US 2030-2038; EU up to 2034). | Patent expiry, entry not confirmed 2028 (compound patent); other patents to 2030 Originator's Annual Report 2025 lists US compound patent expiry 2028 including extensions; other patents to 2030. Company filing | Patent expiry, entry not confirmed 2029 (compound patent + SPC) Originator's Annual Report 2025 lists EU compound patent expiry 2029 including SPC; other patents for Dovato to 2034. Company filing |
| Daratumumab Darzalex, Darzalex Faspro Haematology · biologic Originator holds separate later patents on the subcutaneous formulation, now the main product. | Patent expiry, entry not confirmed 2029 Originator's 2025 10-K and licensor's report: both licensed daratumumab patent families expire in the US in 2029. Company filingCompany filing (2) | Patent expiry, entry not confirmed 2031-2032 (including SPC) Licensor's report gives European expiry 2031 with SPCs; the originator's 10-K says protection extends to 2031/2032 in select countries. Company filingCompany filing (2) |
| Ibrutinib Imbruvica Haematology · small molecule Medicare negotiated price effective 1 January 2026. | Entry expected Mar 2032 (no entry expected before 30 Mar 2032) Originator's 2025 patent table: US compound patent 2027, paediatric exclusivity to May 2028, but no generic entry expected before 30 March 2032. Company filingCompany filing (2) | No confirmed date Ex-US rights held by the originator, which publishes no EU patent or exclusivity date; no EU generic authorised as of October 2026. EMA |
| Lenalidomide Revlimid Haematology · small molecule US volume caps on settled generics lifted 31 January 2026. | On the market Mar 2022 Volume-limited generics launched March 2022 under settlements; the originator's 2025 10-K states licences no longer volume-limited from 31 January 2026. Company filingIMF | On the market Feb 2022 Multiple generics launched across Europe in late February 2022; the originator's 2025 10-K confirms generics have entered the EU market. GaBI OnlineCompany filing |
| Pomalidomide Pomalyst, Imnovid Haematology · small molecule Several EU generics authorised by EMA from February 2024. | On the market Mar 2026 Originator's 2025 10-K expected US generic entry in Q1 2026; first generics launched early March 2026 with shared 180-day exclusivity. Company filing | On the market Aug 2024-Feb 2025 (exact month not documented) Originator's 2023 10-K gave EU regulatory data protection to August 2024; the originator's 2024 10-K states generics have entered Europe. Company filingCompany filing (2) |
| Dupilumab Dupixent Immunology · biologic EU SPCs granted or pending country by country. | Patent expiry, entry not confirmed Mar 2031 Originator's 2025 10-K lists US composition-of-matter patent expiring 28 March 2031 including patent term extension. Company filing | Protected beyond 2032 Mar 2033 (SPC incl. paediatric extension) Originator's 2025 10-K lists EU patent with SPC to September 2032, extended to March 2033 by paediatric extension. Company filing |
| Golimumab Simponi, Simponi Aria Immunology · biologic US entry depends on the appeal and litigation over 17 asserted patents. | No confirmed date First biosimilars FDA-approved May 2026, but a court preliminary injunction of 30 September 2026 blocks launch; appeal pending. Goodwin | On the market Dec 2025 First EU biosimilar authorised November 2025 and launch announced 22 December 2025 (UK first, other markets subject to pricing and reimbursement). Center for Biosimilars |
| Secukinumab Cosentyx Immunology · biologic Later-expiring patents may delay entry; no biosimilar approved yet. | Patent expiry, entry not confirmed 2029 Originator's 2025 20-F lists US patent expiry 2029; the originator says listed dates are not expected biosimilar entry dates. Company filing | Patent expiry, entry not confirmed 2030 Originator's 2025 20-F lists EU expiry 2030 including SPC; listed dates are not expected biosimilar entry dates. Company filing |
| Tocilizumab Actemra, RoActemra Immunology · biologic Further EU biosimilar approved April 2026. | On the market Apr 2024 First US tocilizumab biosimilar launched in April 2024. Center for Biosimilars | Authorised, launch varies Sep 2023 (authorised) First EU tocilizumab biosimilar authorised 15 September 2023; launch month by country not documented. GaBI Online |
| Tofacitinib Xeljanz, Xeljanz XR Immunology · small molecule US extended-release tablet entry may differ under separate settlements. | On the market Jun 2026 First generics (oral solution, then tablets) launched in early June 2026, around expiry of paediatric exclusivity; the originator lists US expiry 2026. Company filing | Entry expected 2028 (regulatory exclusivity) Originator's 2025 10-K lists major EU markets protected to 2028 by regulatory exclusivity. Company filing |
| Ustekinumab Stelara Immunology · biologic | On the market Jan 2025 First US biosimilar launched 1 January 2025 under a patent settlement. Center for Biosimilars | On the market Jul 2024 First EU biosimilar launched across Europe in July 2024, timed to expiry of originator exclusivity. BioPharma Reporter |
| Vedolizumab Entyvio Immunology · biologic No biosimilar approved in either market as of October 2026; US approvals targeted for 2027. | Patent expiry, entry not confirmed 2032 (formulation, dosing patents) Originator's FY2025 20-F: substance patent expired; formulation, dosing and process patents expire 2032, entry timing uncertain; patent suit filed August 2026. Company filingGenerics Bulletin | Patent expiry, entry not confirmed 2032 (formulation, dosing patents) Originator's FY2025 20-F: EU substance patent expired; other patents to 2032; revocation actions brought in the Netherlands in 2026. Company filing |
| Ocrelizumab Ocrevus Neurology · biologic Subcutaneous Ocrevus Zunovo licensed in the US in September 2024. | No confirmed date Originator publishes no Ocrevus patent or exclusivity date; Purple Book lists no exclusivity date and no biosimilar. FDA Purple Book | No confirmed date Originator publishes no Ocrevus EU patent or exclusivity date; no EU biosimilar authorised as of October 2026. EMA |
| Abemaciclib Verzenio, Verzenios Oncology · small molecule Selected for US Medicare price negotiation, per the originator's 2025 10-K. | Entry expected 2031 (compound patent) Originator's 2025 10-K lists US compound patent expiry 2031; no generic litigation disclosed. Company filing | Protected beyond 2032 2033 (compound patent) Originator's 2025 10-K lists major-European compound patent expiry 2033; EU data protection ends 2028. Company filing |
| Apalutamide Erleada Oncology · small molecule Later US patents to 2040 may delay entry beyond compound expiry. | Patent expiry, entry not confirmed Sep 2030 (compound patent) Originator's February 2026 patent table: US compound patent expires 15 September 2030; further Orange Book patents run to 2033-2040. Company filing | No confirmed date Originator publishes no EU patent, SPC or exclusivity date; no EU generic authorised as of October 2026. EMA |
| Enzalutamide Xtandi Oncology · small molecule Originator says ex-US exclusivity expires country by country; US Medicare negotiated price from January 2027. | Entry expected Aug 2027 (compound patent) Originator's 2025 10-K lists US basic product patent 2027; FDA letter lists compound patent expiry 13 August 2027. Company filingFDA | Entry expected 2028 Originator's April 2026 earnings call states European exclusivity runs to 2028; EU generics already authorised since August 2024. Company filing |
| Nivolumab Opdivo Oncology · biologic Subcutaneous Opdivo Qvantig licensed in the US in December 2024. | Entry expected 2028 Originator's 2025 10-K gives US estimated minimum market exclusivity date of 2028. Company filing | Entry expected 2030 Originator's 2025 10-K gives EU estimated minimum market exclusivity date of 2030, based on the UK, France, Germany, Italy and Spain. Company filing |
| Olaparib Lynparza Oncology · small molecule Originator notes US date eligible for six months' paediatric exclusivity. | Patent expiry, entry not confirmed 2027 (compound patent) Originator's and partner's 2025 filings list US compound patent 2027; ANDA litigation pending; other patents run to 2041. Company filingCompany filing (2) | Entry expected 2029 (compound patent + SPC) Originator's patent supplement and partner's 2025 10-K list EU expiry 2029, including SPC. Company filingCompany filing (2) |
| Osimertinib Tagrisso Oncology · small molecule Secondary patents to 2035 could push entry beyond 2032. | Patent expiry, entry not confirmed 2032 (compound patent) Originator's February 2026 patent supplement lists US new-molecular-entity patent 2032 and other patents to 2035. Company filing | Patent expiry, entry not confirmed 2032 (compound patent + SPC) Originator's February 2026 patent supplement lists EU new-molecular-entity patent 2032 and other patents to 2035. Company filing |
| Palbociclib Ibrance Oncology · small molecule US generic tablets already FDA-approved (2023) but not launched; later patents in litigation. | Patent expiry, entry not confirmed Mar 2027 (compound patent with PTE) Originator's 2025 10-K lists US basic patent 2027; PTE to 5 March 2027; litigated formulation patents run to 2034 and 2036. Company filingFDA | Entry expected 2028 (basic patent + SPC) Originator's 2025 10-K lists major-Europe basic product patent expiry 2028; first EU generic authorised June 2026. Company filing |
| Pembrolizumab Keytruda Oncology · biologic Subcutaneous Keytruda Qlex approved September 2025; US Medicare negotiated price expected from 2029. | Patent expiry, entry not confirmed 2028 Originator's 2025 10-K lists US expiry 2028; two further compound-family patents expire 2029 and the originator expects litigation. Company filing | Entry expected 2031 (including SPC) Originator's 2025 10-K lists EU expiry 2031, including SPC, for France, Germany, Italy and Spain. Company filing |
| Pertuzumab Perjeta Oncology · biologic Interchangeable US biosimilar approved November 2025 but not launched; originator patent litigation pending. | Entry expected not before 2028 Originator's 2026 half-year report: primary patents expired Q2 2025; first US biosimilars not anticipated before 2028 (earlier guidance said 2026). Company filingFDA | Entry expected not before 2027 Originator's 2026 half-year report anticipates first European biosimilars not before 2027; first EU biosimilar authorised April 2026. Company filing |
| Trastuzumab emtansine Kadcyla Oncology · biologic No biosimilar approved in the US or EU as of October 2026. | No confirmed date Originator discloses no Kadcyla patent or biosimilar timing; no US biosimilar licensed as of September 2026 Purple Book. FDA Purple Book | No confirmed date Originator discloses no Kadcyla patent or biosimilar timing; no EU biosimilar authorised as of October 2026. EMA |
| Aflibercept Eylea Ophthalmology · biologic Originator lists an EU SPC to May 2028; launches proceed country by country. Covers 2 mg, not 8 mg. | On the market Oct 2024 First US biosimilar launched October 2024 after an appeal court refused an injunction; settlements allow further entrants from H2 2026. Big Molecule Watch | On the market Dec 2025 Biosimilars launched in major EU markets incl. Germany in mid-December 2025; the originator's 2025 10-K confirms EU launches. Company filing |
| Ranibizumab Lucentis Ophthalmology · biologic Originator states Lucentis faces biosimilar competition in the EU; exact first EU launch month unconfirmed. | On the market Jul 2022 First US biosimilar became commercially available on 1 July 2022. Center for Biosimilars | On the market 2023 (at latest) Several biosimilars EU-authorised from 2021; on sale in several EU countries by April 2023 (trade press). Earlier national launches not confirmed. GaBI Online |
| Eculizumab Soliris Rare disease · biologic | On the market Apr 2025 Settlement licensed US entry from 1 March 2025; first biosimilars launched in April 2025. pharmaphorum | Authorised, launch varies 2023 (authorised) First EU eculizumab biosimilars authorised April-May 2023; launch month by country not documented. Center for Biosimilars |
| Tafamidis Vyndaqel, Vyndamax Rare disease · small molecule US compound patent extended by interim PTE; Delaware litigation pending. EU crystal-form patent revoked February 2026. | Entry expected Jun 2031 (settlements) Originator, April 2026: three settlements set effective US patent expiry for Vyndamax at 1 June 2031, subject to other litigation. Company filingCompany filing (2) | Entry expected Feb 2030 (orphan exclusivity, ATTR-CM) Originator: compound patent SPCs expire November 2026 in most European countries; ATTR-CM orphan market exclusivity runs to February 2030. Fierce PharmaCompany filing |
| Macitentan Opsumit Respiratory · small molecule Pulmonary arterial hypertension. US formulation and use patents listed to 2029. | On the market Q2 2026 (late) Compound patent paediatric exclusivity expired 5 June 2026; the originator's Q3 2026 results attribute Opsumit decline to generics entering late Q2. Earnings reportFDA Orange Book | No confirmed date Originator gives no EU patent or SPC expiry; EU generic authorisation exists but launch timing is undocumented. |
| Nintedanib Ofev Respiratory · small molecule First US generics labelled for idiopathic pulmonary fibrosis; Orange Book orphan exclusivity runs to March 2027 with paediatric extension. | On the market Apr 2026 FDA approved first generics on 2 April 2026, after compound patent paediatric exclusivity ended 1 April 2026; one maker announced launch upon approval. FDARespiratory Therapy | No confirmed date Originator publishes no EU patent or SPC expiry; EU generic authorisations exist but launch timing is undocumented. |
| Omalizumab Xolair Respiratory · biologic EU launch month per country not documented; 300 mg strength rolled out in 2026. | On the market Oct 2026 First US biosimilar (interchangeable) FDA-approved March 2025; launch announced 5 October 2026. Allergic Living | On the market 2025 (by Nov 2025) First biosimilar launched in Germany, France, Spain and the Netherlands during 2025 after Norway in September; the originator lists EU compound patent expired. Korea Biomedical ReviewCompany filing |
How to read the status
- On the market: at least one generic or biosimilar has launched in that market. In the EU, launch dates can differ from country to country.
- Authorised, launch varies: copies hold an EU marketing authorisation, but we could not confirm the first launch month.
- Entry expected: the originator, a settlement or a regulator gives a date or a year from which copies may be sold.
- Patent expiry, entry not confirmed: we know when the main patent (or SPC) ends, but later patents, data protection or litigation may delay entry.
- Protected beyond 2032: the earliest documented date falls after 2032.
- No confirmed date: we found no reliable public date, or a court order or dispute leaves it open. We do not guess.
Method
For each molecule we checked the originator's latest annual report or patent table, FDA Orange Book and Purple Book entries, EMA authorisations, and launch reports, up to 16 October 2026. Where sources disagree we show the more conservative date and say why. EU dates refer to the main markets; national SPCs, court cases and pricing decisions can move them by months. Peptides such as semaglutide and liraglutide are approved as generics, not biosimilars. Supplementary protection certificates (SPCs) extend patents in Europe.
Spotted a date that has moved? Tell us and we will check it before the next review.
Questions
What is the difference between a patent expiry and generic entry?
A patent expiry is the date one patent ends. Generic or biosimilar entry is the date copies can actually be sold, which can come later because of other patents, regulatory data protection, settlements or court orders, or earlier when a patent is invalidated. This tracker shows both and says which one each date is.
Does a US or EU launch mean I can import the generic into my country?
Not by itself. Patents and approvals are national, so a medicine can be generic in the US and still protected where you sell, or the reverse. Your regulator decides what can be registered, and many accept dossiers built for FDA or EMA approval.
How often is the tracker updated?
We review every entry each quarter and when a major court decision, settlement or launch is announced. The next full review is due in January 2027.
Cite or reuse this tracker
The data is free to reuse under CC BY 4.0, with a link to this page.
PharmaTradz BD Team. Generic and Biosimilar Entry Tracker 2026–2032 (US and EU). PharmaTradz; updated 16 October 2026. https://pharmatradz.com/generic-entry-tracker
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Send your requirement Medicines going generic in 2026 and 2027Brand names are trademarks of their respective owners and are shown only to identify the reference medicine. This tracker is general information, not legal advice: patents and approvals are national, so check the position in each country before you plan supply.
