FDA Orange Book · active-ingredient family
Olaparib
Olaparib is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:LYNPARZA · NDA 208558
2
Brand (NDA)
0
Generics (ANDA)
12
Listed patents
6
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LYNPARZARLD×2 | ASTRAZENECA | NDA 208558 | — | Aug 17, 2017 | |
| LYNPARZARLD | ASTRAZENECA | NDA 206162 | — | Dec 19, 2014 |
Marketing exclusivity (6)
- I-914New indication exclusivity (3 years)
May 31, 2026
19 d ago
- ODE-283Orphan-drug exclusivity (7 years)
Dec 27, 2026
in 6 mo
- ODE-306Orphan-drug exclusivity (7 years)
May 08, 2027
in 11 mo
- I-914New indication exclusivity (3 years)
May 31, 2026
19 d ago
- ODE-283Orphan-drug exclusivity (7 years)
Dec 27, 2026
in 6 mo
- ODE-306Orphan-drug exclusivity (7 years)
May 08, 2027
in 11 mo
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8143241 | Aug 12, 2027 | in 1 yr 2 mo | U-1634 |
| 8071579 | Aug 12, 2027 | in 1 yr 2 mo | U-3631 |
| 7449464 | Sep 08, 2027 | in 1 yr 3 mo | SubstanceProduct |
| 8247416 | Sep 24, 2028 | in 2 yr 4 mo | Substance |
| 11633396 | Oct 07, 2029 | in 3 yr 4 mo | Product |
| 12048695 | Oct 07, 2029 | in 3 yr 4 mo | Product |
| 12178816 | Oct 07, 2029 | in 3 yr 4 mo | Product |
| 12144810 | Oct 07, 2029 | in 3 yr 4 mo | Product |
| 11975001 | Oct 07, 2029 | in 3 yr 4 mo | Product |
| 8475842 | Dec 31, 2029 | in 3 yr 7 mo | Product |
| 8859562 | Aug 04, 2031 | in 5 yr 2 mo | U-1634 |
| 11970530 | Oct 25, 2041 | in 15 yr 7 mo | U-3929 |
Olaparib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
