Nintedanib patent expiry?

Question

Accepted Answer

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

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.
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.
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,