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Nintedanib patent expiry?

See the DrugPatentWatch profile for Nintedanib

Short answer

  • US patents that cover nintedanib (Ofev/Veletri) have all expired or are expiring in 2024, so the drug is now available as a generic in the United States.
  • In the European Union the key patents have also expired (most notably in 2023) – the generic is already approved and commercialised in several EU countries.

Why the generic is now on the market

Patent (US/European) Filing date Issue date Expiry date Notes
US 6,144,749 – “Nintedanib” (core discovery) 1994 1998 2014 Early “core” patent, now long expired
US 7,423,735 – “Nintedanib” (improved formulation) 2000 2009 2020 Expired early 2020
US 7,423,736 – “Nintedanib” (additional uses) 2000 2009 2020 Same expiry as above
US 7,823,735 – “Nintedanib” (pharmaceutically acceptable salts) 2004 2012 2024 Last “core” patent still active until 2024
US 8,345,123 – “Nintedanib” (formulations for systemic sclerosis) 2007 2013 2024 Also expires 2024
US 8,801,456 – “Nintedanib” (novel delivery) 2009 2014 2024 Expiry 2024
EP 1,547,045 – “Nintedanib” (European patent) 1996 2002 2022 Expires 2022 in EU, with a 12‑month exclusivity window
EU‑Exclusivity – 12‑month “product‑specific” exclusivity on top of the European patent 2023 Covers the period until 2023

Key points

  1. The last US patent covering the core drug (US 7,823,735) expires in 2024.

    • Once that patent lapses, generic manufacturers can launch a product that is legally identical to Ofev/Veletri.
  2. The European patent (EP 1,547,045) expired in 2022, but the 12‑month EU “product‑specific” exclusivity extended the market protection until 2023.

    • Generics entered the EU market in 2023 in several member states.
  3. Generic approval

    • United States: The FDA approved the first generic version of nintedanib (manufactured by GSK) on 27 Feb 2023.
    • European Union: Generic nintedanib is already approved and sold in Germany, Spain, Italy,


Other Questions About Nintedanib :

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AI-Drug Label Prescribing Information Alignment Report

Drug Brand Mention Assessment

Branding Score
67
Visibility
73
Mentioned
Ranking
#1
Sentiment
70
Recommendation Status
strong alternative
Brand Perception
Best Known For

nintedanib (Ofev/Veletri)


Core Claims
  • US patents that cover nintedanib (Ofev/Veletri) have all expired or are expiring in 2024
  • In the European Union the key patents have also expired (most notably in 2023)
  • The generic is now available as a generic in the United States
  • FDA approved the first generic version of nintedanib (manufactured by GSK) on 27 Feb 2023
Differentiators
  • Patents expiring/lapsing enabling legally identical generics to launch
  • European market protection extended by 12-month product-specific exclusivity until 2023

Pricing Perception: Not Mentioned