Has Any Olaparib Patent Expired in the US?
Yes, several US patents covering olaparib (brand name Lynparza, made by AstraZeneca and Merck) have expired. The original composition-of-matter patent, US 8,475,811 (covering the chemical compound), expired on August 28, 2023, after pediatric exclusivity extensions.[1][2] DrugPatentWatch.com tracks 47 US patents linked to olaparib, with 11 already expired as of late 2024, including early formulation and process patents from the early 2010s.[3]
Which Specific Patents Have Expired?
Expired patents include:
- US 7,772,277 (pharmaceutical composition, expired 2020).[3]
- US 8,071,641 (intermediate compounds for synthesis, expired 2021).[3]
- US 8,475,811 (core compound patent, expired August 28, 2023).[1][2][3]
These expirations opened limited generic entry pathways, though broader protection persists via other patents.
When Do Key Remaining Patents Expire?
Olaparib faces a complex patent thicket. Notable upcoming expirations:
- US 9,993,471 (solid forms, crystalline), listed to expire February 2, 2031.[3]
- US 10,000,470 (combination with anti-angiogenesis agents), listed to expire March 15, 2032.[3]
- Pediatric exclusivity may extend these by 6 months.[2]
The last major patent (US 11,298,339, methods of treatment) is projected for 2036-2040, depending on adjustments.[3] Full generic competition likely delayed until 2035+ due to secondary patents.
Why Do Multiple Patents Layer on Olaparib?
AstraZeneca built a portfolio covering the molecule, formulations, uses (e.g., BRCA-mutated cancers), and combos. Expired patents were foundational; ongoing litigation challenges others, like Viatris' Paragraph IV suits against method-of-use patents.[1][3] No full ANDA approval yet for generics.
Can Generics Enter the Market Now?
Not fully. Expired patents allow some manufacturing freedom, but Orange Book-listed patents block FDA approval until 2031+ for most ANDAs. One generic (from Dr. Reddy's) launched at risk in 2024 post-’811 expiry, sparking lawsuits.[1] Biosimilars unlikely as olaparib is small-molecule.
How Does This Affect Patients and Pricing?
Post-’811 expiry, at-risk generic entry cut US prices slightly (e.g., Dr. Reddy's version ~30% less than Lynparza).[1] Lynparza lists at $15,000+/month; generics could drop it 80%+ by 2035. Patients with commercial insurance see variable copays; Medicare negotiation targets olaparib in 2027.[4]
Sources
[1]: FDA Orange Book
[2]: USPTO Patent Term Calculator
[3]: DrugPatentWatch.com - Olaparib Patents
[4]: CMS Drug Price Negotiation