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See the DrugPatentWatch profile 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]
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]
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]
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
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