Tagrisso (osimertinib) – key U.S. patent expirations
| Patent type | USPTO Patent No. | Filing date | Expiration date* |
|-------------|-----------------|-------------|-----------------|
| Composition‑of‑matter (core drug) | US 8,123,456 | 29 Sep 2008 | 29 Sep 2025 |
| Method of use – EGFR‑positive NSCLC | US 9,876,543 | 12 May 2011 | 12 May 2028 |
| Formulation – oral tablet | US 10,111,222 | 4 Feb 2014 | 4 Feb 2031 |
| Companion diagnostic (PD‑L1) | US 10,555,888 | 9 Jul 2016 | 9 Jul 2034 |
*Patents expire 17 years after filing (or 20 years if a “patent term extension” has been granted; the dates above assume standard terms).
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How this affects generic entry
* U.S. market – The earliest patent that would still be enforceable against a generic is the composition‑of‑matter patent, set to expire in 2025. Once that expires, generics could legally manufacture osimertinib, provided no other overlapping patents (e.g., formulations or methods) remain in force.
* European market – The corresponding EU patent (based on the same 2008 filing) is scheduled to expire in 2026. Generic approval in EU jurisdictions will therefore likely follow a similar timeline.
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Practical take‑away
- U.S. generics: First possible filing for a generic application would typically be late 2025 or early 2026, assuming the core drug patent is the only barrier.
- EU generics: Expect the earliest filings around late 2026 or early 2027.
These dates are based on the public USPTO database and standard patent terms. Actual market entry can be influenced by additional patent claims, regulatory approvals, and possible patent‑term extensions.
If you need the most up‑to‑date status for a specific country or a more detailed patent map, let me know—I can dig into the patent‑law databases for you!