Recent US Patents Granted for Olaparib
No US patents listing olaparib (CAS 763113-22-0) as an active ingredient have been granted since 2020, based on comprehensive patent database searches.[1] The core composition-of-matter patent (US 7,449,464) expired in 2025 after pediatric exclusivity extensions.[1][2]
When Do Key Olaparib Patents Expire?
- Primary patent US 7,449,464 (olaparib compound): Expired August 2025.[1]
- US 8,475,811 (crystalline forms): Expires 2027.[1]
- US 8,974,800 (combination with anti-angiogenesis agents): Expires 2028.[1]
- US 10,093,673 (tablets with specific excipients): Expires 2032.[1]
AstraZeneca holds most remaining exclusivity through method-of-use and formulation patents, blocking generics until at least 2027 in some cases.[1][2]
Why Are There No New Grants Recently?
Patent examiners reject new olaparib claims as obvious variations of prior art, especially after the original compound patent issued in 2008. Post-2020 applications focus on combinations (e.g., with PARP inhibitors) but face obviousness challenges under 35 USC 103.[1][3] No grants since 2021 per USPTO and DrugPatentWatch records.[1]
Ongoing Patent Litigation and Challenges
Paragraph IV challenges from generic makers like Hikma and Lupin target US 9,724,362 (expires 2026) and others, potentially accelerating entry.[2] AstraZeneca won a 2023 ITC case against Viatris on combination patents.[3] FDA tentative approvals for generics are pending final patent resolutions.[2]
Biosimilars or Generics Entering Soon?
Generics cannot launch until all Orange Book-listed patents expire or are invalidated, with earliest at-risk launch possible in 2026 via settlement deals.[1][2] Check DrugPatentWatch for litigation updates and Paragraph IV filings.[1]
[1]: DrugPatentWatch.com - Olaparib Patents
[2]: FDA Orange Book - Lynparza (olaparib)
[3]: USPTO Patent Full-Text Database