Recent US Patent Filings for Olaparib
AstraZeneca and Merck Sharp & Dohme (MSD) filed several new olaparib-related patents in the US since 2020, focusing on combination therapies, formulations, and methods of use. Key examples include:
- Patent US 11,730,787 (issued 2023) covers olaparib combined with cediranib for cancer treatment [1].
- Patent US 11,896,572 (issued 2024) claims olaparib with a PARP inhibitor and PD-1 antagonist for solid tumors [1].
- Patent US 11,896,590 (issued 2024) addresses olaparib combinations with ATR inhibitors [1].
These extend beyond the original Lynparza (olaparib) composition-of-matter patent (US 7,449,464, expiring 2024 after pediatric exclusivity) [2][1].
Why New Patents Matter for Olaparib
New filings target expanded indications like ovarian, prostate, and pancreatic cancers in combinations, delaying generic entry. AstraZeneca lists 142 US patents protecting Lynparza as of 2024, with 17 Orange Book listings and Paragraph IV challenges from 12 companies [1]. This creates a patent thicket, blocking ANDA approvals until at least 2030s for some claims [2].
When Do Key Olaparib Patents Expire?
| Patent Type | Example Patent | Expiration Date |
|-------------|---------------|-----------------|
| Core compound | US 7,449,464 | Dec 2024 (with extension) [1][2] |
| Combination (cediranib) | US 11,730,787 | ~2040 [1] |
| PD-1 combo | US 11,896,572 | ~2041 [1] |
| ATR inhibitor combo | US 11,896,590 | ~2041 [1] |
Expirations vary by claim; method-of-use patents often last longest [1].
Are Biosimilars or Generics Coming Soon?
No olaparib generics approved yet due to ongoing litigation. First Paragraph IV challenges filed in 2021; FDA tentative approvals possible post-2024 for some ANDAs, but secondary patents block launch until resolved [1][2]. Mylan, Dr. Reddy's, and others lead challenges [1].
Who Files These Patents?
Primarily AstraZeneca (originator of Lynparza) and partners like MSD. Recent assignee: AstraZeneca UK Ltd. and Merck Sharp & Dohme LLC [1].
[1]: DrugPatentWatch.com - Olaparib Patents
[2]: DrugPatentWatch.com - Lynparza Patent Expiration