FDA Orange Book
Is there a generic for Lynparza?
Lynparza contains olaparib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lynparza (olaparib). The Orange Book shows its last listed patent expires October 25, 2041 and its last listed exclusivity ends May 8, 2027.
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Lynparza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 50MG | Discontinued | None | 0 | None |
| tablet, oral | 100MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 150MG | Marketed (Rx) | None | 0 | None |
NDA 206162, 208558, held by ASTRAZENECA PHARMACEUTICALS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lynparza patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8143241 | August 12, 2027 | Method of use | U-1634 | 206162 |
| 8143241 | August 12, 2027 | Method of use | U-2482 | 208558 |
| 8143241 | August 12, 2027 | Method of use | U-2480 | 208558 |
| 8143241 | August 12, 2027 | Method of use | U-2716 | 208558 |
| 8143241 | August 12, 2027 | Method of use | U-2483 | 208558 |
| 8143241 | August 12, 2027 | Method of use | U-3631 | 208558 |
| 8071579 | August 12, 2027 | Method of use | U-3631 | 208558 |
| 8071579 | August 12, 2027 | Method of use | U-2716 | 208558 |
| 8071579 | August 12, 2027 | Method of use | U-2483 | 208558 |
| 8071579 | August 12, 2027 | Method of use | U-2482 | 208558 |
| 8143241 | August 12, 2027 | Method of use | U-2824 | 208558 |
| 8143241 | August 12, 2027 | Method of use | U-2823 | 208558 |
| 8143241 | August 12, 2027 | Method of use | U-2821 | 208558 |
| 8143241 | August 12, 2027 | Method of use | U-2819 | 208558 |
| 8143241 | August 12, 2027 | Method of use | U-2820 | 208558 |
| 8143241 | August 12, 2027 | Method of use | U-2822 | 208558 |
| 8071579 | August 12, 2027 | Method of use | U-3695 | 208558 |
| 8143241 | August 12, 2027 | Method of use | U-3695 | 208558 |
| 8071579 | August 12, 2027 | Method of use | U-2820 | 208558 |
| 8071579 | August 12, 2027 | Method of use | U-2824 | 208558 |
| 8071579 | August 12, 2027 | Method of use | U-2833 | 208558 |
| 8071579 | August 12, 2027 | Method of use | U-2823 | 208558 |
| 8071579 | August 12, 2027 | Method of use | U-2832 | 208558 |
| 8071579 | August 12, 2027 | Method of use | U-2480 | 208558 |
| 8071579 | August 12, 2027 | Method of use | U-2821 | 208558 |
| 8071579 | August 12, 2027 | Method of use | U-2819 | 208558 |
| 8071579 | August 12, 2027 | Method of use | U-2822 | 208558 |
| 8143241 | August 12, 2027 | Method of use | U-2832 | 208558 |
| 8143241 | August 12, 2027 | Method of use | U-2833 | 208558 |
| 8143241 | August 12, 2027 | Method of use | U-3333 | 208558 |
| 8071579 | August 12, 2027 | Method of use | U-3333 | 208558 |
| 7449464 | September 8, 2027 | Drug substance, Drug product | None | 208558 |
| 8247416 | September 24, 2028 | Drug substance | None | 206162 |
| 11633396 | October 7, 2029 | Drug product | None | 208558 |
| 12048695 | October 7, 2029 | Drug product | None | 208558 |
| 12178816 | October 7, 2029 | Drug product | None | 208558 |
| 12144810 | October 7, 2029 | Drug product | None | 208558 |
| 11975001 | October 7, 2029 | Drug product | None | 208558 |
| 8475842 | December 31, 2029 | Drug product | None | 208558 |
| 8859562 | August 4, 2031 | Method of use | U-1634 | 206162 |
| 8859562 | August 4, 2031 | Method of use | U-2101 | 208558 |
| 8859562 | August 4, 2031 | Method of use | U-2483 | 208558 |
| 8859562 | August 4, 2031 | Method of use | U-2482 | 208558 |
| 8859562 | August 4, 2031 | Method of use | U-2716 | 208558 |
| 8859562 | August 4, 2031 | Method of use | U-2480 | 208558 |
| 8859562 | August 4, 2031 | Method of use | U-3631 | 208558 |
| 8859562 | August 4, 2031 | Method of use | U-2103 | 208558 |
| 8859562 | August 4, 2031 | Method of use | U-2833 | 208558 |
| 8859562 | August 4, 2031 | Method of use | U-2822 | 208558 |
| 8859562 | August 4, 2031 | Method of use | U-2821 | 208558 |
| 8859562 | August 4, 2031 | Method of use | U-2823 | 208558 |
| 8859562 | August 4, 2031 | Method of use | U-2824 | 208558 |
| 8859562 | August 4, 2031 | Method of use | U-2820 | 208558 |
| 8859562 | August 4, 2031 | Method of use | U-2819 | 208558 |
| 8859562 | August 4, 2031 | Method of use | U-3695 | 208558 |
| 8859562 | August 4, 2031 | Method of use | U-2832 | 208558 |
| 8859562 | August 4, 2031 | Method of use | U-3333 | 208558 |
| 11970530 | October 25, 2041 | Method of use | U-3929 | 208558 |
| 11970530 | October 25, 2041 | Method of use | U-3930 | 208558 |
| 11970530 | October 25, 2041 | Method of use | U-3931 | 208558 |
Lynparza exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-914 | New indication | May 31, 2026 | 208558 |
| ODE-283 | Orphan drug exclusivity | December 27, 2026 | 208558 |
| ODE-306 | Orphan drug exclusivity | May 8, 2027 | 208558 |
Lynparza NDC codes
Questions
Is there a generic for Lynparza?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lynparza (olaparib). The Orange Book shows its last listed patent expires October 25, 2041 and its last listed exclusivity ends May 8, 2027.
What is the generic name for Lynparza?
The active ingredient in Lynparza is olaparib, per the FDA Orange Book.
When does the Lynparza patent expire?
The last patent listed for Lynparza in the Orange Book expires October 25, 2041. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.