When does nintedanib’s patent expire in Spain?
I can’t determine a specific nintedanib patent expiry date for Spain from the information available here. Patent and exclusivity timelines vary by:
- which exact product (e.g., Ofev) is being discussed,
- the active ingredient vs. specific formulations/process claims,
- the particular patent family and its filing/grant dates,
- and whether you mean patent expiry or regulatory exclusivity (which can extend beyond the basic patent term).
What determines nintedanib (Ofev) exclusivity end dates in Spain?
For Spain, “expiry” can mean different legal events:
- Patent term end for the relevant national/granted patents in Spain (often tied to priority/filing dates).
- Supplementary Protection Certificate (SPC) and its end date, if granted (commonly used to extend protection for medicines).
- Other regulatory data/exclusivity protections that may affect when generics or biosimilars can be marketed (depending on the pathway used and the legal basis).
Is there an SPC for nintedanib in Spain?
Whether nintedanib has an SPC in Spain depends on the outcome of the SPC application and the specific EU/Spanish regulatory decisions for the marketing authorization. Without the relevant SPC/patent record, I can’t state if an SPC exists or its expiry date.
How to quickly find the correct expiry date for Spain
To get the exact “Spain expiry” date for nintedanib, you generally need to look up:
- The Spanish patent(s) covering nintedanib for the marketed product in Spain (often via the relevant patent office records or legal status databases).
- Any SPC linked to the nintedanib marketing authorization (SPC records are decisive for the effective expiry date in practice).
- Whether the question is about the first generic launch date (which depends on litigation, SPC status, and regulatory approvals) or the last possible patent/SPC date.
If you share whether you mean Ofev (nintedanib) and whether you want patent expiry or SPC/exclusivity expiry, I can narrow down what to look for and what type of record usually contains the date you want.
Sources
None provided.