Current US Patents for Olaparib
Olaparib (Lynparza), developed by AstraZeneca and Merck, holds multiple US patents covering the compound, formulations, and uses in cancer treatment. Key patents include US 7,446,113 (expires 2026, basic compound) and US 8,475,842 (expires 2028, tablet formulation), with pediatric exclusivity extending some to 2029.[1]
Are There Pending US Patents?
Yes, AstraZeneca and partners have several pending US patent applications for olaparib-related innovations, including new formulations, combination therapies, and expanded indications like ovarian and prostate cancers. Examples from recent USPTO filings:
- US 2023/0125899 (pending; improved oral formulations for better bioavailability).
- US 2024/0055978 (pending; combinations with immunotherapies).
- US 2023/0390165 (pending; methods for biomarker-driven dosing).[2][3]
These aim to extend protection beyond core expirations.
When Do Key Patents Expire?
Core composition-of-matter patent US 7,446,113 expires June 26, 2026. Formulation patents like US 10,081,624 run to 2031-2033. Pending applications, if granted, could push exclusivity into the late 2030s via new claims.[1][2]
Pending Patents and Biosimilar Challenges
Pending filings face opposition from generics makers like Viatris and Dr. Reddy's, who challenge validity in inter partes reviews (IPRs). For instance, IPR2023-00742 targets olaparib polymorph patents. Biosimilars cannot launch until at least 2026 without settlements, but litigation delays generics.[3][4]
Who Files Most Pending Patents?
AstraZeneca files the majority (80%+ of recent olaparib applications), often with Merck or licensees. Search DrugPatentWatch for full lists filtered by status.[1]
[1]: DrugPatentWatch.com - Olaparib Patents
[2]: USPTO Patent Center - Olaparib Applications
[3]: FDA Orange Book - Lynparza
[4]: PTAB Tracker - Olaparib IPRs