olaparib · Astrazeneca · NDA 206162, 208558
Lynparza
Earliest generic entry, as listed · earliest of 2 marketed strengths
25 Oct 2041
Blocked by patent: US 11970530. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 12 unexpired
60 Orange Book listing rows for 12 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11970530 | use U-3929, U-3930, U-3931 | 25 Oct 2041 |
| US 11970530 listing row | use U-3929 · sets the listed date | 25 Oct 2041 |
| US 11970530 listing row | use U-3930 · sets the listed date | 25 Oct 2041 |
| US 11970530 listing row | use U-3931 · sets the listed date | 25 Oct 2041 |
| US 8859562 | use U-1634, U-2101, U-2103, U-2480, U-2482, U-2483, U-2716, U-2819, U-2820, U-2821, U-2822, U-2823, U-2824, U-2832, U-2833, U-3333, U-3631, U-3695 | 4 Aug 2031 |
| US 8859562 listing row | use U-1634 | 4 Aug 2031 |
| US 8859562 listing row | use U-2101 | 4 Aug 2031 |
| US 8859562 listing row | use U-2103 | 4 Aug 2031 |
| US 8859562 listing row | use U-2480 | 4 Aug 2031 |
| US 8859562 listing row | use U-2482 | 4 Aug 2031 |
| US 8859562 listing row | use U-2483 | 4 Aug 2031 |
| US 8859562 listing row | use U-2716 | 4 Aug 2031 |
| US 8859562 listing row | use U-2819 | 4 Aug 2031 |
| US 8859562 listing row | use U-2820 | 4 Aug 2031 |
| US 8859562 listing row | use U-2821 | 4 Aug 2031 |
| US 8859562 listing row | use U-2822 | 4 Aug 2031 |
| US 8859562 listing row | use U-2823 | 4 Aug 2031 |
| US 8859562 listing row | use U-2824 | 4 Aug 2031 |
| US 8859562 listing row | use U-2832 | 4 Aug 2031 |
| US 8859562 listing row | use U-2833 | 4 Aug 2031 |
| US 8859562 listing row | use U-3333 | 4 Aug 2031 |
| US 8859562 listing row | use U-3631 | 4 Aug 2031 |
| US 8859562 listing row | use U-3695 | 4 Aug 2031 |
| US 8475842 | drug product | 31 Dec 2029 |
| US 11633396 | drug product | 7 Oct 2029 |
| US 11975001 | drug product | 7 Oct 2029 |
| US 12048695 | drug product | 7 Oct 2029 |
| US 12144810 | drug product | 7 Oct 2029 |
| US 12178816 | drug product | 7 Oct 2029 |
| US 8247416 | drug substance | 24 Sep 2028 |
| US 7449464 | drug substance, drug product | 8 Sep 2027 |
| US 8071579 | use U-2480, U-2482, U-2483, U-2716, U-2819, U-2820, U-2821, U-2822, U-2823, U-2824, U-2832, U-2833, U-3333, U-3631, U-3695 | 12 Aug 2027 |
| US 8071579 listing row | use U-2480 | 12 Aug 2027 |
| US 8071579 listing row | use U-2482 | 12 Aug 2027 |
| US 8071579 listing row | use U-2483 | 12 Aug 2027 |
| US 8071579 listing row | use U-2716 | 12 Aug 2027 |
| US 8071579 listing row | use U-2819 | 12 Aug 2027 |
| US 8071579 listing row | use U-2820 | 12 Aug 2027 |
| US 8071579 listing row | use U-2821 | 12 Aug 2027 |
| US 8071579 listing row | use U-2822 | 12 Aug 2027 |
| US 8071579 listing row | use U-2823 | 12 Aug 2027 |
| US 8071579 listing row | use U-2824 | 12 Aug 2027 |
| US 8071579 listing row | use U-2832 | 12 Aug 2027 |
| US 8071579 listing row | use U-2833 | 12 Aug 2027 |
| US 8071579 listing row | use U-3333 | 12 Aug 2027 |
| US 8071579 listing row | use U-3631 | 12 Aug 2027 |
| US 8071579 listing row | use U-3695 | 12 Aug 2027 |
| US 8143241 | use U-1634, U-2480, U-2482, U-2483, U-2716, U-2819, U-2820, U-2821, U-2822, U-2823, U-2824, U-2832, U-2833, U-3333, U-3631, U-3695 | 12 Aug 2027 |
| US 8143241 listing row | use U-1634 | 12 Aug 2027 |
| US 8143241 listing row | use U-2480 | 12 Aug 2027 |
| US 8143241 listing row | use U-2482 | 12 Aug 2027 |
| US 8143241 listing row | use U-2483 | 12 Aug 2027 |
| US 8143241 listing row | use U-2716 | 12 Aug 2027 |
| US 8143241 listing row | use U-2819 | 12 Aug 2027 |
| US 8143241 listing row | use U-2820 | 12 Aug 2027 |
| US 8143241 listing row | use U-2821 | 12 Aug 2027 |
| US 8143241 listing row | use U-2822 | 12 Aug 2027 |
| US 8143241 listing row | use U-2823 | 12 Aug 2027 |
| US 8143241 listing row | use U-2824 | 12 Aug 2027 |
| US 8143241 listing row | use U-2832 | 12 Aug 2027 |
| US 8143241 listing row | use U-2833 | 12 Aug 2027 |
| US 8143241 listing row | use U-3333 | 12 Aug 2027 |
| US 8143241 listing row | use U-3631 | 12 Aug 2027 |
| US 8143241 listing row | use U-3695 | 12 Aug 2027 |
Exclusivities · 2 unexpired
| ODE-306 | orphan drug (7 years) | 8 May 2027 |
| ODE-283 | orphan drug (7 years) | 27 Dec 2026 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Exclusivity expires within 90 days ODE-283 · 208558-002Exclusivity expires 27 Dec 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days ODE-283 · 208558-001Exclusivity expires 27 Dec 2026Detected 24 Oct 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 206162 · 001 · RLD · discontinued | capsule, oral | 50MG | 4 Aug 2031 |
| 208558 · 001 · RLD | tablet, oral | 100MG | 25 Oct 2041 |
| 208558 · 002 · RLD | tablet, oral | 150MG | 25 Oct 2041 |
Expired or delisted (1)
- I-914 · 31 May 2026