Major Drug Patent Expiries in 2026: Therapeutic Area Breakdown & Generic Entry Strategy

Introduction: Why 2026 Is a Landmark Patent Cliff Year

The year 2026 is going to be very significant in the current cycle of patent expiries. Blockbuster medicines comprising both small molecules and biologics would be on patent expiry. This would result in a considerable gain for:

• Generic drug companies
• API manufacturers
• Bio-similar producers
• Distributors and traders

Along with some drugs, there are also early generic entry cases based on settlements, which would enable the manufacturers to be prepared well in advance. (Read: Best CDMOs for Generic & Off-Patent Drug Manufacturing)

For B2B customers, the year 2026 will be the time for huge-volume opportunities in cases of cardiology, oncology, immunology, and metabolic disorders.

1.High-Impact Drug Patent Expiries in 2026

Here is the important molecules list for which 2026 is the main LOE year:

Eliquis (Apixaban)

Treatment: Anticoagulant
Category: Small molecule

Why 2026 is imporant:

Eliquis is the leading cardiovascular drug in terms of sales worldwide. In the US and EU, the key patent and exclusivity protections begin to be significantly weakened in 2026, with some extensions running to 2027-2029.

Possibilities:

• There will be a very high demand for first-wave generic drugs
• APIs manufacturers in India & China will get very strong chances
• Big-scale hospital and government tenders will be an advantage for the distributors
   

Januvia / Janumet (Sitagliptin)

Therapy: Diabetes
Type: Small molecule
 

Why 2026 is important:

As part of the legal settlements, it is agreed that several generic companies will be allowed to introduce their own versions of sitagliptin and sitagliptin–metformin combinations starting mid-2026 in the most important markets.

Opportunities:

• Enormous demand in India, LATAM, Africa, and Southeast Asia
• Large-scale API requirement
• Perfect fit for makers aiming at metabolic therapy portfolio
   

Xtandi (Enzalutamide)

Therapy: Oncology – prostate cancer
Type: Small molecule

Why 2026 is important:

In many regions worldwide, generic enzymes will be available by 2026–2027.

Opportunities:

• Profitable cancer treatment sector
• Purity of API with a premium focus
• Potential for CDMOs to provide formulation development support is great
   

Stelara (Ustekinumab) – US/EU Late-Stage Transition

Therapy: Immunology (Crohn’s disease, psoriasis)
Type: Biologic

Why 2026 is important: 

Full rollout of biosimilar competition with US, EU, and Asia markets starts in 2024-2026 so 2026 will be the peak year for switching.

Opportunities:

• Early biosimilars can be stocked by distributors
• Those with mAbs skill set can step into this lucrative marketThe expirations in 2026 affect four main therapeutic areas:
   

Tysabri (Natalizumab)

Therapy: Multiple sclerosis
Type: Biologic

Why 2026 is important:

The competition from biosimilar natalizumab gets stronger in Europe and expands to the US market during this period.

Opportunities:

• MS therapy markets are mainly specialty-driven
• Niche CDMOs and biologics manufacturers gain
   

Xarelto (Rivaroxaban)

Therapy: Anticoagulant
Type: Small molecule 

Why 2026 is important:

Like Eliquis, Xarelto faces major LOE milestones in the US and Europe beginning at 2026.

Opportunities:

• High API demand
• Perfect fit for companies boasting solid oral dosage capability
• Competitive but high-volume

2. Therapeutic Area Breakdown

The expirations in 2026 affect four main therapeutic areas:

1) Cardiology & Stroke Prevention

(Eliquis, Xarelto)

Market impact:

• Major switch to generics
• Prices will drop steeply (up to 80–90%)
• High tender-based procurement

Great for:

• Large-volume API suppliers
• Tablet & capsule manufacturers
• Distributors tied to hospitals

2) Diabetes

(Januvia, Janumet)

Market impact:

• Metformin combos will see rapid generic entry
• Emerging markets will absorb large volumes

Great for:

• API suppliers with DMF/CEP in place
• FDF manufacturers targeting government programs
• Wholesalers expanding diabetic-care portfolios

3) Oncology

(Xtandi)

Market impact:

• More affordable oncology access
• Strong opportunities in LATAM, Africa, and Asia

Great for:

• High-quality oncology API manufacturers
• CDMOs offering complex solid oral formulations

4) Immunology & CNS

(Stelara, Tysabri)

Market impact:

• Biosimilar adoption curve begins
• Higher-barrier but profitable segment

Great for:

• Biologics developers
• Companies with fill–finish lines for injectables
• Regional distributors with cold-chain capability
   

3. API & Generic Entry Opportunities (2026 Focus)

3.1 For API Manufacturers

• File DMF/CEP early for apixaban, rivaroxaban, sitagliptin
• Take competitive pricing and full regulatory support as a chance
• Create stability data packages for FDF partners

3.2 For Generic FDF Manufacturers

• Prioritize ANDA filings for Eliquis, Xarelto, Januvia
• Establish long-term partnerships with reputed API suppliers
• Plan for bioequivalence studies well in advance

3.3 For Biosimilar Developers

• Focus on ustekinumab & natalizumab
• Develop large comparability data packages
• Make sure CMC documentation is strong for regulated markets

3.4 For Distributors

• Create a list of molecules based on demand in different regions
• Devise tender strategies for several countries
• Create marketing material for the switch from innovators
   

4. Regional Market View

United States

• Great year for anticoagulants and diabetes generics
• Payers will encourage quick switching
• Severe competition—both quality and price will be crucial

Europe

• Biosimilars of biologics (Stelara, Tysabri) catch on
• EU normally accepts biosimilars faster than US or Asia

India

• Considerable API and FDF export potential
• The domestic market will be highly price-competitive

LATAM, Africa, SEA

• Generics often peak 2–3 years after US/EU LOE
• A great chance for distributors who target ministry tenders
   

5. How Manufacturers & Distributors Should Prepare

A. API Makers

• Lock-in supply contracts early
• Publish updated COAs & regulatory dossiers
• Keep an aggressive pricing strategy

B. Generic Manufacturers

• If entering early, then initiate BE studies now
• Optimize your cost-of-goods (COGs)
• Build launch plans for multiple markets

C. Distributors

• Watch for approval updates
• Plan for inventory levels
• Prepare educational material for doctors & clinics

6. Risks & Patent-Litigation Considerations

• Secondary and formulation patents may delay launches
• Some countries require additional exclusivity checks
• Biosimilar uptake depends on physician confidence
• Market saturation may occur quickly in diabetes and cardiology

Stay updated through Orange Book, EMA registers, and ongoing litigation. . (Also Read: Top Revenue-Loss Drugs After Patent Expiry & API Market Potential)

Frequently Asked Questions(FAQs)

1. Will all generics launch exactly in 2026?

Not always—launch timing depends on settlements, litigation, and regulatory approval.

2. Are these molecules high-volume?

Yes, especially Eliquis, Xarelto, and Januvia, which are among the highest-selling drugs globally.

3. Which markets should I target first?

Focus on: US, Europe, India, Brazil, Mexico, South Africa, Philippines, GCC markets.

4. How early should a manufacturer prepare?

Ideally 18–24 months before the LOE year.