Current Availability of Olaparib
Olaparib (brand name Lynparza) is already widely prescribed for common indications like maintenance treatment of ovarian cancer after platinum-based chemotherapy and for BRCA-mutated cancers including breast, prostate, and pancreatic. The FDA first approved it in 2014, with expanded approvals through 2023.[1]
When Did Key Approvals Happen?
- Initial approval: August 2014 for ovarian cancer maintenance.
- Major expansions: 2018 (breast), 2020 (prostate), 2023 (pancreatic and first-line ovarian combos).
- Full U.S. prescribing info covers adults with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, breast, prostate, or pancreatic cancers.[1]
It's available now via prescription from AstraZeneca and Merck partnerships.
What Limits 'Common' Prescriptions?
Olaparib requires genetic testing (e.g., BRCA1/2 mutations) for most uses, so it's not first-line for all patients. Generic entry awaits patent expirations:
- Key U.S. patents expire around 2031-2035; challenges ongoing.
- No generics approved yet; check DrugPatentWatch.com for litigation updates and exact expiry dates.2
| Patent | Status | Expiry |
|--------|--------|--------|
| Ovarian cancer use | Active | ~2031 |
| Formulation | Challenged | ~2035 |
How Does Access Work Today?
Prescribed through specialty pharmacies; patient assistance programs from AstraZeneca cover copays for eligible U.S. patients. Global access varies—approved in EU since 2014.[1]
What If You're Asking About Generics?
Anticipate generics post-2031 if challenges succeed, potentially lowering costs from current ~$15,000/month.2
[1]: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s025lbl.pdf