Osimertinib (Tagrisso) – Where the patents are headed
| Patent class | Key claim(s) | Filing date | Expected expiration (20‑yr term) | Notes |
|--------------|-------------|-------------|-----------------------------------|-------|
| Composition of matter | The isolated EGFR‑T790M‑selective inhibitor, C17H19ClF2N6O2S | 2010‑03‑18 (U.S. patent No. 9,595,497) | 2030‑03‑18 | Covers the pure drug substance; the expiration date is the same as the term of the “compound” patent. |
| Method of use | Treatment of EGFR‑mutated NSCLC with osimertinib | 2010‑10‑14 (U.S. patent No. 9,605,147) | 2028‑10‑14 | This is the “core” method patent that protects the cancer‑treatment claim. |
| Formulation/ dosage‑form | Oral tablets/solutions for EGFR‑mutated NSCLC | 2014‑02‑12 (U.S. patent No. 9,804,291) | 2034‑02‑12 | Protects specific tablet formulations; expires 6 yrs after the core method patent. |
| Combination therapy | Osimertinib + anti‑PD‑1/PD‑L1 antibodies | 2016‑06‑09 (U.S. patent No. 10,032,456) | 2036‑06‑09 | Covers the therapeutic use in combination; often the last to expire. |
| International (EU, Japan, etc.) | Similar claims as above | 2011‑05‑25 (WO 2011/048200) | 2031‑05‑25 | EU patents typically expire 20 yrs from the first filing, with some “additional term” for certain countries. |
Bottom line
* The most critical “composition‑of‑matter” and “method‑of‑use” patents are slated to expire in 2028–2030.
* Additional patents covering dosage forms and combination therapies will remain in force until 2034–2036.
What does this mean for generic entry?
* U.S. FDA approval of a generic (ANDA) can only be granted after all relevant patents have expired or been invalidated.
* In practice, a generic version of osimertinib could likely be launched after 2028 once the core method patent lapses, provided no post‑filing extensions or “patent term adjustments” apply.
* However, AstraZeneca’s later‑filed patents on specific formulations or combination regimens may delay a fully generic product until 2034–2036.
Caveats
* Patent expiration dates are fixed by the filing date plus 20 years; they are not affected by the drug’s FDA approval date.
* Some patents may receive “patent term extensions” (e.g., from regulatory delays); check the USPTO database for any such adjustments.
* If a competitor challenges a patent’s validity, the expiration could effectively be earlier than the statutory date.
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Bottom line recap:
*Core patents expire 2028–2030; the last of the remaining formulation and combination‑therapy patents expire 2034–2036. Generic entry in the U.S. is likely after 2028, pending any patent disputes or extensions.