Drug Patent Expiries: Complete Guide for Pharma Manufacturers & Distributors (2025–2030)

Introduction

Typically, drug patent expiries drive the global pharmaceutical market. When a key item begins to lose its patent, the floor is opened for newcomers, creating a number of potential suppliers including Generic Drug Manufacturers, API Manufacturers etc. The price reduces tremendously, the number of competitors in the area increases, and demand is being met rapidly.

This guide outlines potential opportunities related to the largest patent expirations between 2025 and 2030 and how pharmaceutical manufacturers can prepare for these expirations. The guide is designed specifically for API Manufacturers, Generic Drug Manufacturers, API Distributors, CDMOs and Global Buyers.

1. What Is a Drug Patent Expiry?

The expiration of a Pharmaceutical Patent allows for all competitors to manufacture and sell the Generic version following the expiration. For the term of the Patent, the Originator holds all exclusive rights to that Pharmaceutical's use, and therefore the marketplace is closed; an event occurs following the expiration, allowing multiple manufacturers to distribute their manufactured product into the marketplace.

Key points to know are:

• A bulk of Drug Patents last for about 20 years from the original date of filing
• However; there are several other forms of exclusivity available, such as Pediatric Exclusivity, Orphan Drug Exclusivity, and Hatch-Waxman Extensions), which can add additional exclusivity for Drug patents beyond the standard 20-year period.
• Upon expiration, the potential for multiple manufacturers to begin competing within the market will exist.
• In many cases due to the rapid increase of competition, most of the pricing of that Drug can decline rapidly and in some cases 70%-95% within a 12-month period.

For All pharmaceutical manufacturers and buyers, a Drug Patent Expiration can generate many opportunities and options for sourcing products.
 

2. Why Patent Expiries Matter to the Pharma Industry

Drug Patent Expiration Events shift market conditions. An understanding of these events will allow All Pharmaceutical Manufacturers to:

• Identify the "Molecules" that are ready for Generic Manufacturing and selling

• Plan on their API Manufacturing Capacity and Sourcing

• Calculate their estimations for price drop and estimated profitability

• Prepare their required Regulatory Documentation's (ANDA, Dossiers and CTDs)

• Estimate forecast of demand from Global Buyers

The Expiry of a Major Drug can change the Revenue Stream of All Manufacturers by Literally Billions of Dollars.
 

3. Major Drug Patent Expiries (2025–2030)

(Grouped by year with high-value molecules)

Below is a strategic overview of key molecules losing protection.
 

Patent Expiries in 2025

Key molecules losing exclusivity:

• Eylea (Aflibercept) – Ophthalmology
• Opdivo (Nivolumab) – some regions
• Zepbound/Mounjaro (Tirzepatide) – formulation patents begin to weaken
• Ibrance (Palbociclib) – Oncology

Opportunities: Oncology generics, biosimilars, diabetes/obesity segments.

Patent Expiries in 2026

High-impact drugs:

• Stelara (Ustekinumab) – Immunology
• Eliquis (Apixaban) – Anticoagulant
• Xtandi (Enzalutamide) – Oncology
• Tysabri (Natalizumab) – Neurology

This will be a major year for biosimilars.
 

Patent Expiries in 2027

Key losses:

• Keytruda (Pembrolizumab) – one of the largest patent cliffs ever
• Trelegy Ellipta
• Januvia/Janumet (Sitagliptin) – global regions
• Xeljanz (Tofacitinib)

Massive opportunities for both APIs and CDMO services.
 

Patent Expiries in 2028

Expected expiries:

• Ozempic (Semaglutide) – Diabetes/Weight Loss (in some regions)
• Entresto (Sacubitril/Valsartan)
• Imbruvica (Ibrutinib)
• Darzalex (Daratumumab)

Demand for metabolic drugs will surge.

Patent Expiries in 2029

High-value molecules:

• Ocrevus (Ocrelizumab) – MS
• Tagrisso (Osimertinib)
• Dupixent (Dupilumab) – strong global interest
• Repatha (Evolocumab)

Biosimilar competition will be intense.
 

Patent Expiries in 2030

Major losses:

• Cosentyx (Secukinumab)
• Skyrizi (Risankizumab)
• Trulicity (Dulaglutide)
• Farxiga (Dapagliflozin) final protections

These expiries will shift therapeutic markets worldwide.
 

4. Therapeutic Areas Impacted the Most (2025–2030)

Patent cliffs will have the largest impact in:

A. Oncology

• Keytruda
• Opdivo
• Ibrance
• Imbruvica

B. Immunology

• Stelara
• Cosentyx
• Skyrizi
• Xeljanz

C. Metabolic Diseases

• Ozempic
• Mounjaro
• Trulicity
• Farxiga

D. Cardiology

• Eliquis
• Entresto
• Repatha

E. Neurology

• Ocrevus
• Tysabri

These therapy areas will see steep price corrections and intense competition.
 

5. Market Opportunities for API Manufacturers

By utilizing the benefits associated with the patent expirations of API producers, generic drug manufacturers and associated distributors/traders alike will see positive revenue growth in the upcoming months/years and an increase in opportunities stemming from their business growing globally through the expansion of the generic and off-patent drug markets. 

Advantages to API producers that are associated with the expiration of patents are:

1) Entering the market with high demand molecules in advance

Being among the first 3–5 suppliers boosts global sales.

2) Setting up regulatory filings in advance

Establishing DMFs and/or CEPs ahead of expiration to ensure a competitive advantage.

3) Offering competitive pricing and stable supply

Providing competitive pricing and stable supplies, particularly in larger volume markets (i.e. United States, Europe, Latin America, Middle East and North Africa, South East Asia).

4) Partnering with Generic FDF Manufacturers

Forming partnerships with generic FDF (finished dosage form) manufacturers for joint development contracts, which aids in winning high volume deals.

5) Leveraging post-expiry price decline periods

Using decreasing prices of the product during the first two years of patent expirations to gain new and/or different suppliers.
 

6. Opportunities for Generic Drug Manufacturers

Generic companies benefit when:

• Filing ANDAs prior to the expiration of the patent (Para III or Para IV as applicable)
• Obtaining supply partnerships with API manufacturers
• Attaining first to file exclusivity (U.S. only)
• Developing low cost production capabilities
• Expanding into fast approval emerging markets

With the expiration of patents, manufacturers of generic drugs have the opportunity to launch new products, submit applications for tenders and/or approvals to the relevant authorities, through the expiration of the patents for these drugs.
 

7. How Drug Distributors & Global Traders Benefit

Drug distributors and global traders can:

• Lock in bulk purchase agreements prior to price decreases hitting the market
• Build new supply chains to carry off patent drugs
• Focus on bulk volume sales to the African, Latin American, and Southeast Asian markets
• Carry large volumes in inventory and stock those products expected to see an increase in market acceptance in the period following the expiration of their patents
• Expand their portfolio to include low cost, high-quality generics

Immediate price drops create new opportunities for margin optimization.
 

8. How to Get Ready for Drug Patent Expiries (Step-by-Step Guide)

The following describes how to prepare for the expiration of a patent for the purpose of benefiting from patent expirations.

1. Track Patent Expiration Dates

Research Patent Expiration dates utilizing resources such as:

• Orange Book
• European Patent Office Patent Registration
• World Intellectual Property Organization (WIPO)
• Canadian Patent Office

2. Assess API availability

Be aware of:

• The number of Drug Master Files (DMFs) filed
• The Number of Certificates of Suitability (CEPs) ssued
• Current manufacturers who produce the API
• Pricing trends related to the API

3. Analyze market size

Check:

• The Current sales
• The initial price of Originator product
• Future pricing trends

4. Begin Filing Regulatory Applications Early

For example:

• Abbreviated New Drug Application (ANDA) In The USA
• DCP, or MRPs In Europe
• WHO PQ Applications
• Regulatory Applications for Emerging Markets

5. Develop partnerships

Collaborate with:

• API suppliers
• Contract Development And Manufacturing Organizations (CDMOs)
• Packaging companies
• Regional distributors

6. Prepare for a shift in Supply Chains

Diversify procurement across:

• India
• China
• Europe
• Southeast Asia

7. Monitor competition

Monitor The Following Types Of Companies:

• The First-to-File Generic Companies
• The Biosimilar Manufacture Companies
• The Additional Regional Manufacturer Companies
   

9. Common problems associated with Patent Expiration windows

Companies face challenges like:

• Limited availability of API Suppliers in the early stages
• High Initial API Costs
• Complicated Litigation that delays the launch of an API
• Regulatory delays concerning sSpecific Geographical Locations
• Price decreases associated with generic entry
• Quality issues arising from a new supplier

Careful Planning Can Mitigate These Risks.
 

10. Practical Suggestions for Pharma Companies

For API Makers

• File DMFs 12-24 Months Prior To Patent Expiration
• Provide Stability Testing Data
• Technology Support
• Develop A Cost-Effective Advantage Early

For Generic Manufacturers

• Prepare ANDAs with robust bioequivalence data supporting your application
• Avoid relying on a Single Supplier
• Consider Co-Development Models

For Distributors

• Focus your distribution efforts on Volume-Based Markets
• Be aware that Preemptorial strategies will mitigate the risks of competition in the Market
• Track customer needs (hospitals, tenders, chains)