October
Polpharma ocrelizumab biosimilar starts its first trial
Teva licensed the candidate in 2026 for the US and other markets.
When do generics and biosimilars of the biggest drugs arrive?
The dates that could change who sells blockbuster drugs in the US: entry dates set by settlements and courts, patent expiries, court and FDA decisions, and Medicare price deadlines. 8 dated events fall in the next 12 months.
Teva licensed the candidate in 2026 for the US and other markets.
Deadline for CMS to publish the negotiated prices for the drugs selected for 2028. The prices take effect on 1 January 2028.
Discounts of 40% to 71% below list price for these drugs, before the rebates drugmakers already pay.
Amgen is the furthest along of the US-focused developers.
Generic makers have filed since 2019; Pfizer settled some cases on undisclosed terms.
Alvotech's application, with Teva as US seller, was accepted in June 2026. Takeda says patents running to 2032 still have to be cleared before launch.
AstraZeneca settled with MSN in December 2025; the case against Cipla is set for trial.
Generics from Sandoz and others are FDA-approved but have not launched while Pfizer and Astellas pursue patent suits.
None of the four generic filers challenges this patent, so this is the earliest the FDA can approve them.
Company guidance. Lilly 10-K: US compound patent and data protection end 2027.
Prices are due from CMS by 30 November 2026.
A court barred Sandoz and Zydus until the key patent expires on this date; Amgen settled with other filers on confidential terms.
Settlements let most of the original 25 generic filers launch from this date; the three that lost in court must wait for a patent expiring in 2031.
The second expires in December 2028. Incyte has settled with five of nine challengers on confidential terms.
No US biosimilar filing has been announced; Samsung Bioepis has filed in Korea.
Incyte puts its minimum US market exclusivity at 2028.
Patent-expiry estimate. Key patents expire around 2028. Sales fell 39% in 2025 on weaker China demand.
Company guidance. BMS guides to US biosimilar entry from 2028. Subcutaneous Opdivo Qvantig may extend the franchise.
Patent-expiry estimate. Pfizer 10-K: US basic patent 2026, with an extension to 2028 pending. Sales are the Vyndaqel family (Vyndaqel and Vyndamax), for a rare heart disease.
Biosimilars are in development; Amgen is furthest along.
Two biosimilars are FDA-approved but cannot launch until then.
A methods-of-treatment patent runs to May 2032. No confirmed US biosimilar filing yet.
Patent-expiry estimate. Key exclusivities expected to end around 2029.
Patent-expiry estimate. Core US patents expire 2029. Formulation patents on subcutaneous Darzalex Faspro run longer.
MSN has FDA approval, but an appeals court upheld Exelixis's patents in August 2026.
Company guidance. Lilly 10-K: US compound patent 2030; US biologics data protection runs to 2028.
Under settlements with Exelixis.
Sanofi plans to defend exclusivity beyond this date. Biosimilars are in early development.
Company guidance. Gilead 10-K: US patent expiry 2031 (Europe 2027). Gilead sued Cipla in February 2026 over a patent challenge. HIV treatment and prevention.
Company guidance. AstraZeneca 20-F: US patent protection expected to 2031.
Company guidance. Novartis 20-F: US compound patent 2031 (already expired in Europe). Multiple sclerosis; sales grew 37% in 2025.
Company guidance. Novartis 20-F: US compound patent 2031. Sales grew 58% in 2025.
Company guidance. J&J 10-K: US composition patent family projected to expire in 2031. Sales grew 40% in 2025, which J&J attributes to share gains and market growth.
Company guidance. Lilly 10-K: US compound patent 2031.
After a 2021 court ruling and settlements, assuming pediatric exclusivity. Hetero already has FDA approval.
Patent-expiry estimate. AstraZeneca lists US patents expiring between 2026 and 2036; generic makers challenged them from 2024.
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).
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.
Patent-expiry estimate. Some US patents expire 2032; the last listed patent runs to 2035.
Company guidance. Same molecule as Ozempic (semaglutide), sold for obesity. Novo: US compound patent expiry 2032; semaglutide generics launched in India and Canada in 2026. Sales DKK 79.1B.
Company guidance. AbbVie 10-K: US composition-of-matter patents expire 2033.
Company guidance. Pfizer 10-K: US basic product patent expires 2035. Sales are the whole Prevnar family.
Company guidance. AstraZeneca 20-F: US patent protection expected to 2035. Rare immune and blood diseases.
Gilead settled with all three generic filers in October 2025.
Company guidance. Lilly 10-K: US compound patent expires 2036. Excludes Zepbound, the same molecule sold for obesity.
Company guidance. Same molecule as Mounjaro (tirzepatide), sold for obesity. Lilly 10-K: US compound patent 2036.
AbbVie settled with every generic filer in September 2025, assuming pediatric exclusivity.
Patent-expiry estimate. Patents run to about 2037. Cystic fibrosis. Excludes the successor Alyftrek ($0.8B).
Entry dates come from settlements, court rulings and licenses: the day copies are allowed to launch. A patent expiry is when a key patent or extension ends, but later patents or litigation can still delay copies. Rows marked "date not disclosed" are drugs whose US exclusivity is expected to end that year without a public day or month. Every row links to its source, and past dates move to what changed.