Current Key Olaparib Patents in the US
Olaparib (Lynparza), marketed by AstraZeneca and Merck, has multiple US patents covering the drug substance, formulations, and methods of use. The core composition-of-matter patent (US 7,446,122) expires in 2025, but newer patents extend protection.[1] DrugPatentWatch lists 22 Orange Book-listed patents for Lynparza tablets, with the latest expirations in 2032–2038.[2]
When Do Major Patents Expire?
- Earliest expiry: August 26, 2025 (US 7,446,122, drug substance).[2]
- Key formulation patents: US 10,335,462 (expires 2033) covers tablet forms.[2]
- Pediatric exclusivity adds 6 months to some, pushing effective expiry to early 2026 for base patents.[1][2]
Full generic entry is blocked until at least 2032 due to method-of-use patents like US 9,937,196 (BRCA-mutated cancers).[2]
Recent New Patent Grants
AstraZeneca secured several post-2020 grants:
- US 11,590,982 (March 2023): Covers combination therapies with cediranib.[3]
- US 11,219,615 (January 2022): New salt forms for improved stability.[2][3]
- US 11,351,154 (June 2022): Dosing regimens for maintenance therapy in ovarian cancer.[2]
These extend exclusivity beyond 2035 for specific indications.[2]
Ongoing Patent Challenges
Generic makers are litigating:
- Viatris challenged US 10,335,462 and others in 2021; AstraZeneca prevailed in 2023 at PTAB.[1][2]
- Sun Pharma and Dr. Reddy's filed Paragraph IV certifications targeting 2032 patents; cases settled with delayed entry to 2033–2037.[2]
- FDA tentative approvals for generics (e.g., Viatris in 2023) await final patent resolutions.[1]
Biosimilars or Generics Timeline
No generics approved yet. First filers like Mylan/Viatris have 180-day exclusivity upon launch, likely post-2032. Biosimilars unlikely as olaparib is a small molecule.[2] European generics launch sooner (2025 in some countries).[1]
Impact on Pricing and Access
Patents keep US list price at ~$15,000/month. Challenges could lower costs 80%+ post-entry, but settlements delay this.[2] Patient assistance programs cover copays during exclusivity.[1]
Sources
[1] FDA Orange Book
[2] DrugPatentWatch.com - Lynparza Patents
[3] USPTO Patent Database