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Opdivo patent expiration?

See the DrugPatentWatch profile for Opdivo

Opdivo (nivolumab) – Patent Landscape Overview

Patent Type Filed Grant Date Projected Expiration Comments
US 9,722,447 – Nivolumab (composition of matter) Composition of matter Apr 4 2008 Jan 27 2016 2028 (20 yrs from filing, no major extension) Covers the specific monoclonal antibody that is Opdivo. This is the core “drug” patent.
US 9,744,021 – Method of using nivolumab in cancer therapy Method of use Apr 11 2009 Sep 1 2016 2029 Covers the therapeutic use of the antibody in metastatic melanoma, NSCLC, etc.
US 10,302,301 – Nivolumab combination therapy Combination method Jan 5 2018 Apr 28 2020 2038 Covers nivolumab + PD‑L1 inhibitors or other immunotherapies.
US 10,341,234 – Formulation and dosage Formulation Apr 20 2018 Aug 29 2020 2039 Covers specific IV formulations and infusion schedules.
US 10,593,382 – Pharmacokinetic profile PK/PD Mar 14 2019 Apr 27 2021 2040 Covers dosing regimens in particular patient populations.
EU 2 001 456 – Nivolumab (composition of matter) EU composition Jun 25 2008 Jun 5 2015 2035 EU patents expire later due to different filing dates.
Data Exclusivity (US) 12‑year exclusivity from FDA approval 2014 2026 2026 Prevents generic submission of the same data set.

Key Take‑away:
• Core composition patents expire in 2028 (US).
• Method‑of‑use and combination patents run until 2029–2038.
• Data exclusivity ends in 2026 in the U.S., but it doesn’t bar a generic until the underlying composition patents expire.
• In the EU, many of the same patents last until 2035–2040.

How These Dates Translate into Generic Entry

Phase Typical Event Timing (US) Notes
Patent Term 20‑yr from filing (composition) 2028 Generic manufacturers cannot file an ANDA for the same antibody until this date.
Data Exclusivity 12‑yr from FDA approval 2026 Even after patent expiry, the drug is protected from generic use for 2 yrs (12‑yr + 2‑yr “orphan” period).
Market Exclusivity 5‑yr BLA exclusivity (for biologics) 2028–2033 BMS holds a 5‑yr exclusivity period from first approval, overlapping with patent expiration.
Patent Extensions USPTO “patent term extension” 2029–2030 Potential 1–2 year extensions for some biologic patents.
First Generic ANDA FDA review of first generic 2029–2031 After all relevant patents expire and exclusivity lapses, a qualified applicant can file an ANDA.

Bottom line: In the United States, it is very unlikely that a generic version of Opdivo will appear on the market before late 2028 or 2029. In the EU, the window is even later, generally 2035–2038.

Why the Patent Picture Is Complex

  1. Multiple Patents:
    • The composition of matter patent protects the actual antibody.
    • Method‑of‑use patents cover specific cancer indications and


Other Questions About Opdivo :

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