FDA Orange Book
Is there a generic for Zejula?
Zejula contains niraparib. 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 Zejula (niraparib). The Orange Book shows its last listed patent expires January 25, 2039 and its last listed exclusivity ends April 29, 2027.
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Zejula products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 100MG BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 200MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 300MG BASE | Marketed (Rx) | None | 0 | None |
NDA 208447, 214876, held by GLAXOSMITHKLINE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zejula patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8071579 | August 12, 2027 | Method of use | U-2655 | 208447 |
| 8143241 | August 12, 2027 | Method of use | U-2655 | 208447 |
| 8436185 | April 24, 2029 | Drug substance | None | 208447 |
| 8071623 | March 27, 2031 | Drug substance, Drug product | None | 208447 |
| 8859562 | August 4, 2031 | Method of use | U-2655 | 208447 |
| 11673877 | March 27, 2038 | Drug product | U-3646 | 208447 |
| 11673877 | March 27, 2038 | Drug product | U-3647 | 208447 |
| 11091459 | March 27, 2038 | Drug product | None | 208447 |
| 11730725 | January 25, 2039 | Drug product | None | 214876 |
Zejula exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-277 | Orphan drug exclusivity | October 23, 2026 | 208447 |
| ODE-295 | Orphan drug exclusivity | April 29, 2027 | 208447 |
Zejula NDC codes
Questions
Is there a generic for Zejula?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zejula (niraparib). The Orange Book shows its last listed patent expires January 25, 2039 and its last listed exclusivity ends April 29, 2027.
What is the generic name for Zejula?
The active ingredient in Zejula is niraparib, per the FDA Orange Book.
When does the Zejula patent expire?
The last patent listed for Zejula in the Orange Book expires January 25, 2039. 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.