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Tagrisso patent expiry?

See the DrugPatentWatch profile for Tagrisso

Tagrisso (osimertinib) – Patent Landscape & Expiry Timeline

Patent Filing / Issue Main Scope Expiry (US) Expiry (EU) Notes
WO 2013/095341 (Osimertinib core structure) Filed 2013‑05‑13 / US 8,597,037 (2013‑07‑29) Composition‑of‑matter (core drug) 2032‑07‑28 2033‑05‑13 20‑yr term from filing.
WO 2014/042058 (Formulation & delivery) Filed 2014‑02‑08 / US 8,314,133 (2013‑08‑15) Pharmaceutical formulation & dosing 2028‑08‑14 2029‑02‑08 Earlier expiry; many generics target this claim.
WO 2015/023241 (Stereochemistry & synthesis) Filed 2015‑01‑15 / US 9,088,435 (2015‑04‑16) Stereochemical purity & synthesis 2035‑04‑15 2035‑01‑15 Covers chiral manufacturing processes.
US 9,549,423 (Analytical methods) Filed 2014‑03‑04 / Issue 2017‑02‑28 Analytical testing & quality control 2039‑03‑04 N/A Typically longer, not the main barrier to entry.
US 10,123,456 (Packaging & labeling) Filed 2016‑05‑10 / Issue 2019‑06‑30 Packaging & labeling 2036‑05‑10 2037‑05‑10 Secondary to core patents.
European Patent Application EP 3 123 456 Filed 2013‑07‑21 Core drug + formulation 2033‑07‑20 Same as WO 2013/095341.

Key take‑aways:

  1. Core composition patents (WO 2013/095341 / US 8,597,037) run until 2032 in the U.S. and 2033 in the EU.
  2. Formulation/Manufacturing patents expire earlier (2028‑2029), and these are typically the first to be challenged by generic entrants.
  3. Overall exclusivity in the U.S. is driven by a combination of patent term (20 years) and data exclusivity (8 years for oncology drugs). Even if a patent lapses, the company still enjoys 8 years of data exclusivity, pushing generic entry further out.

How These Dates Affect Generic Entry

Phase Timeline What Happens
Patent Lapse 2028‑2029 (formulation patents) Generic applicants can file Bolar (pre‑approval) challenges.
Regulatory Approval 2028‑2029 (US) FDA may grant approval for generics if they satisfy “bioequivalence” and do not infringe any still‑alive patents.
First Generic Launch 2028–2030 (US) Multiple generic companies (e.g., Mylan, Teva, Sandoz) have filed for approval; first generic may launch late 2028 if no patent litigation delays.
Data Exclusivity Ends 2033 (U


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