Current Count of Active Olaparib Patents in the US
DrugPatentWatch tracks 24 active patents covering olaparib (brand name Lynparza) in the US as of the latest data. These include patents on the drug substance, formulations, methods of use, and manufacturing processes.[1]
What Do These Patents Protect?
Most active patents focus on combination therapies (e.g., with bevacizumab for ovarian cancer), specific crystalline forms, and dosing regimens. Key examples:
- US Patent 10,961,096: Covers methods for treating homologous recombination-deficient cancers, expiring May 2033.
- US Patent 11,298,352: Protects tablet formulations, expiring September 2033.
Several extend beyond the original composition-of-matter patent (US 8,475,842, expired 2025) through secondary protections.[1]
When Do the Last Patents Expire?
The final olaparib patents expire in December 2036, primarily due to pediatric exclusivity extensions on method-of-use patents. This delays generic entry despite earlier expirations.[1]
Are Any Patents Facing Challenges?
Yes, 12 olaparib-related patents have Paragraph IV challenges from generic makers like Dr. Reddy's and Lupin, mostly targeting ovarian cancer use patents. Litigation is ongoing in district courts, with some settlements reported.[1]
Who Owns These Patents?
AstraZeneca and Merck Sharp & Dohme hold all 24 active patents as assignees. No third-party ownership.[1]
[1]: DrugPatentWatch.com - Olaparib (Lynparza) Patents