Loss of exclusivity · US · 2025–2037

The pharma patent cliff

Blockbuster drugs grouped by the year the first US generic or biosimilar can launch. Each block is sized by the drug's 2025 worldwide sales, the revenue its owner has to replace.

2025 sales exposed, by US loss-of-exclusivity year ($B)

Date fixed (launched, settled or guided) Estimated from patent expiry ex-US Exclusivity ends earlier outside the US
Data table and sources ( drugs)
US LOEDrugCompanyArea2025 salesDate basisNoteSources
2025 Entresto Novartis Cardiometabolic $7.7B Generics launched US generics entered in Q3 2025. Novartis Q4 2025
2025 Stelara Johnson & Johnson Immunology $6.1B Generics launched US biosimilars from Jan 2025. Sales were $10.4B in 2024, before entry. J&J FY2025
2025 Prolia Amgen Other $4.4B Generics launched Denosumab biosimilars launched in the US from mid-2025. Bone health. Amgen FY2025
2026 Farxiga AstraZeneca Cardiometabolic $8.4B Generics launched FDA approved the first US generics on 7 April 2026. AZ FY2025
FDA
2026 Pomalyst Bristol Myers Squibb Oncology $2.7B Generics launched US generics launched March 2026 under settlements. BMS FY2025
2027 Xtandi Astellas / Pfizer Oncology ≈$6.0B Patent-expiry estimate Last listed US patent expires August 2027. Sales: Astellas global, ¥960.8B (fiscal year to March 2026). Fierce Pharma
2027 Trulicity Eli Lilly Cardiometabolic $4.3B Company guidance Lilly 10-K: US compound patent and data protection end 2027. Lilly 10-K
2027 Ibrance Pfizer Oncology $4.1B Patent-expiry estimate US patent term extended to March 2027. Pfizer FY2025
Pfizer PTE
2028 Keytruda Merck Oncology $31.7B Company guidance Primary US compound patent expires December 2028. Includes subcutaneous Keytruda Qlex. EU exclusivity to 2031. Merck FY2025
Merck 10-K
2028 Eliquis Bristol Myers Squibb / Pfizer Cardiometabolic $14.4B Settlement / court date US generics barred until 1 April 2028 after patent win and settlements. EU generics earlier. Sales as reported by BMS; Pfizer separately books $8.0B of alliance and product revenue. BMS FY2025
2028 Opdivo Bristol Myers Squibb Oncology $10.1B Company guidance BMS guides to US biosimilar entry from 2028. Subcutaneous Opdivo Qvantig may extend the franchise. BMS FY2025
2028 Gardasil Merck Vaccines $5.2B Patent-expiry estimate Key patents expire around 2028. Sales fell 39% in 2025 on weaker China demand. Merck FY2025
2029 Darzalex Johnson & Johnson Oncology $14.3B Patent-expiry estimate Core US patents expire 2029. Formulation patents on subcutaneous Darzalex Faspro run longer. J&J FY2025
2029 Ocrevus Roche Neuroscience ≈$8.4B Patent-expiry estimate Main US patent protection runs to March 2029. Sales CHF 7.01B. Roche FY2025
2029 Cosentyx Novartis Immunology $6.7B Patent-expiry estimate Key exclusivities expected to end around 2029. Novartis Q4 2025
2029 Enbrel Amgen Immunology $2.2B Settlement / court date Court-upheld patents block approved biosimilars until April 2029. Amgen FY2025
GaBI
2031 Dupixent Sanofi / Regeneron Immunology $17.8B Company guidance Extended US patent runs to 28 March 2031. Sanofi plans to defend exclusivity beyond that. Regeneron FY2025
Fierce Pharma
2032 Ozempic Novo Nordisk Cardiometabolic ≈$19.3B Company guidance Novo guides to US compound patent expiry in 2032. Generics launched in India and Canada in 2026 as patents lapsed there. Sales DKK 127.1B. Novo AR 2025
2032 Tagrisso AstraZeneca Oncology $7.3B Patent-expiry estimate Some US patents expire 2032; the last listed patent runs to 2035. AZ FY2025
2032 Entyvio Takeda Immunology ≈$6.0B Company guidance Takeda pushed its assumed US biosimilar entry back to 2032 on formulation and manufacturing patents. Sales ¥958.0B (fiscal year to March 2026). Takeda FY2025
Pharma Japan
2033 Skyrizi AbbVie Immunology $17.6B Company guidance AbbVie 10-K: US composition-of-matter patents expire 2033. AbbVie 10-K
2035 Prevnar 20 Pfizer Vaccines $6.5B Company guidance Pfizer 10-K: US basic product patent expires 2035. Sales are the whole Prevnar family. Pfizer 10-K
2036 Mounjaro Eli Lilly Cardiometabolic $23.0B Company guidance Lilly 10-K: US compound patent expires 2036. Excludes Zepbound, the same molecule sold for obesity. Lilly 10-K
2036 Biktarvy Gilead Infectious disease $14.3B Settlement / court date Settlements bar US generics before 1 April 2036, later than the earlier 2033 estimate. Gilead FY2025
Fierce Pharma
2037 Trikafta Vertex Other $10.3B Patent-expiry estimate Patents run to about 2037. Cystic fibrosis. Excludes the successor Alyftrek ($0.8B). Vertex FY2025
2037 Rinvoq AbbVie Immunology $8.3B Settlement / court date September 2025 settlements bar US generics before April 2037. Consensus had assumed 2032. AbbVie 10-K
Fierce Pharma