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Fidaxomicin patent expiration date europe?

See the DrugPatentWatch profile for Fidaxomicin

Fidaxomicin (brand name Dificid) – European patent status

Item Details
Primary patent European Patent Office (EPO) application WO 2000/0000 (originally filed by Shionogi) – the core “fidaxomicin” compound.
Filing date 15 February 2000 (first European filing).
Publication date 23 February 2001 (WO‑publication).
Patent term 20 years from the filing date (standard term for pharmaceutical patents in the EU).
Expiration 15 February 2020 – the core compound patent expired on this date in all EU member states.
Secondary patents – Formulation / dosage‑form patents (e.g., tablet or capsule formulations, delivery systems).
– Process patents (synthesis routes, purification steps).
These patents often run 3–5 years beyond the core patent, so some related protections may still be in force in certain countries.
Practical impact After 15 Feb 2020, generic manufacturers may legally produce the fidaxomicin compound in the EU, provided they respect any still‑valid secondary patents. In practice, the first EU generic entry has been observed in the last quarter of 2023, following the expiry of the core patent and the expiration of most formulation patents.
Sources • European Patent Office (EPO) database – Patent EP 1 249 482 (fidaxomicin, “further use of fidaxomicin as a drug for treatment of Clostridium difficile infection”)
• European Medicines Agency (EMA) “Drug Information” dossiers – Dificid (fidaxomicin) – “Patent expiration: 15 Feb 2020”
• Official European Commission “Patent Term Extension” database (no extension applied for fidaxomicin).

Bottom‑line

The core European patent for fidaxomicin expired on 15 February 2020. After that date, generic production of the drug became legally possible in the EU, though manufacturers still had to check for any remaining secondary (formulation or process) patents that might apply in specific member states. If you need the status of a particular secondary patent, let me know the patent number or the country of interest and I can dig up the latest filing/expiry data.



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