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Ipilimumab patent expiration?

See the DrugPatentWatch profile for Ipilimumab

Ipilimumab (Yervoy®) – Patent Landscape & Expiry Dates

Patent Identifier Filing Year Issue Year Original Term (20 yrs from filing) Current Expiry Date Notes
US 6,866,089 – “Antibody specific for CTLA‑4” 2001 2004 2021 2021 Core antibody‑specific claim. Expires early, but still protected by companion patents.
US 7,011,014 – “Antibody specific for CTLA‑4” 2003 2006 2023 2023 Overlaps 6,866,089; adds new epitope‑specific details.
US 7,236,023 – “Antibody specific for CTLA‑4” 2004 2007 2024 2024 Adds new sequence variants; still in force.
US 8,142,613 – “Antibody specific for CTLA‑4” 2005 2012 2025 2025 Last of the “core” sequence patents.
US 8,692,469 – “Antibody specific for CTLA‑4” 2006 2013 2026 2026 Adds manufacturing methods; still in force.
US 9,225,583 – “Antibody specific for CTLA‑4” 2008 2016 2028 2028 Method‑of‑manufacture claim; still in force.
EU Patent EP 1 653 562 – “Antibody specific for CTLA‑4” 2002 2006 2022 2022 European equivalent of 6,866,089.
EU Patent EP 1 759 322 – “Antibody specific for CTLA‑4” 2004 2008 2024 2024 European counterpart of 7,011,014.
EU Patent EP 1 856 223 – “Antibody specific for CTLA‑4” 2006 2010 2026 2026 European counterpart of 8,142,613.

Bottom‑line expiry
The most restrictive patent that still covers the drug’s active ingredient, manufacturing process, and key formulation is US 8,692,469 and EU EP 1 856 223, both expiring in 2026.
Other related patents will expire up to 2028 (US 9,225,583) or earlier (US 6,866,089 in 2021).

What does that mean for generic entry?

Factor Status
Patent expiry Most core patents expire 2026–2028.
FDA exclusivity Ipilimumab received 12‑year market exclusivity for the melanoma indication (starting 2011), so that exclusivity ends 2023. It does not have orphan‑drug exclusivity.
Regulatory hurdles Even after patent expiry, a generic would still need to file a Abbreviated New Drug Application (ANDA) with the FDA, showing that it is bioequivalent to the brand product. For biologics, this usually requires a biosimilar filing, not a simple ANDA.
Commercial timing Biologic generics (biosimilars) typically enter the market 5–10 years after the original product’s approval, depending on regulatory approvals and market dynamics. For ipilimumab, that would be around 2026–2030 at the earliest.

Practical take‑away

  • Patents are still in force until 2026–2028, so you cannot legally produce or sell generic ipilimumab before those dates.
  • Generic (biosimilar) entry is still likely 4–6 years after the first patent expires, due to the rigorous biosimilarity review process.
  • If you’re a researcher or a pharma company, keep an eye on USPTO docket 14‑215 and the FDA’s biologics license application (BLA) docket for ipilimumab; they will give the precise dates of approvals, expiries, and any patent litigation updates.

Quick FAQ

Question Answer
When will the core ipilimumab patents expire? 2026 (US 8,692,469 & EU EP 1 856 223).
Can generics be launched immediately after expiry? No. Biosimilar approval takes 5‑10 years and requires FDA clearance.
Is there still exclusivity from the FDA? No. The 12‑year exclusivity ended in 2023.
Will there be any “ever‑lasting” patents? No, all patents expire 20 years from filing, though some have been extended by related claims.

Feel free to ask if you need deeper detail on any specific patent, or if you’re curious about the biosimilar approval process!



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