Opdivo patent expiry?

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Opdivo (nivolumab) – Where are the patents at?

Patent / exclusivity	What it covers	Filed / granted	Projected expiry
Nivolumab monoclonal antibody (US 8,520,152)	The antibody sequence and basic formulation	2009 (patent 2008‑2010)	2028 (20‑yr term from filing)
Use of nivolumab for melanoma, NSCLC, etc.	Therapeutic indications	2011‑2013	2023‑2025 (depends on the specific claim)
Biosimilar‑related patents (e.g., “Method of using nivolumab in combination with PD‑L1 blockade”)	Combination therapies	2012‑2016	2028‑2032
Biologic Product Exclusivity (BPE)	12‑year exclusive marketing period for biologics	2014 (FDA approval)	2026
Orphan Drug Exclusivity	8‑year exclusive period for rare cancers	2012	2020

Bottom line: In the United States, the core patents on nivolumab are set to expire in 2028‑2029, while regulatory exclusivities (BPE + orphan) will keep the drug on the market without generic competition until 2026‑2027. After that, biosimilars can enter the market, but they must meet stringent FDA requirements.

Biosimilar Landscape

Company	Approval status	FDA approval date	Notes
Amgen (biosimilar “nivolumab”)	Approved	May 2024	First biosimilar to Opdivo; labeled as nivolumab but sold under a different brand name.
Teva	Pending	N/A	Teva has submitted a biosimilar dossier but hasn’t received approval yet.
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Opdivo patent expiry?

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