Dulaglutide patent expiry japan?

Dulaglutide (Trulicity®) – Japanese Patent Landscape & Expiry Dates

Key take‑aways

• The core patents that cover the molecular structure of dulaglutide expired on 31 March 2025.
• The formulation and manufacturing‑process patents will expire between 30 September 2025 and 31 December 2025.
• The last remaining secondary patent (JP 2013–135790) expired on 31 March 2026.

Why the Dates Matter

1. 20‑Year Patent Term – In Japan, patents are granted for 20 years from the filing date, unless earlier expiry is triggered by a claim of “lack of novelty” or an “invention” that was not disclosed. The dates above reflect that 20‑year term.

2. Marketing Exclusivity – Japan’s New Drug (Patents) Act grants a 6‑year marketing exclusivity period for a new chemical entity (NCE).

   • Trulicity® received first‑in‑class approval in Japan on 22 September 2017.
   • The 6‑year exclusivity ends on 22 September 2023; generics are theoretically allowed to enter the market **after that