FDA Orange Book
Is there a generic for Rubraca?
Rubraca contains rucaparib camsylate. 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 Rubraca (rucaparib camsylate). The Orange Book shows its last listed patent expires August 17, 2035 and its last listed exclusivity ends December 17, 2028.
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Rubraca products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 200MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 250MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 300MG BASE | Marketed (Rx) | None | 0 | None |
NDA 209115, held by PHARMAAND GMBH. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Rubraca patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8143241 | August 12, 2027 | Method of use | U-2012 | 209115 |
| 8071579 | August 12, 2027 | Method of use | U-2273 | 209115 |
| 8071579 | August 12, 2027 | Method of use | U-2012 | 209115 |
| 8143241 | August 12, 2027 | Method of use | U-2273 | 209115 |
| 8071579 | August 12, 2027 | Method of use | U-2830 | 209115 |
| 8143241 | August 12, 2027 | Method of use | U-2830 | 209115 |
| 9861638 | February 10, 2031 | Method of use | U-2012 | 209115 |
| 9861638 | February 10, 2031 | Method of use | U-2273 | 209115 |
| 8754072 | February 10, 2031 | Drug substance, Drug product | None | 209115 |
| 10278974 | February 10, 2031 | Drug product | None | 209115 |
| 9045487 | February 10, 2031 | Drug substance, Drug product | None | 209115 |
| 8859562 | August 4, 2031 | Method of use | U-2012 | 209115 |
| 8859562 | August 4, 2031 | Method of use | U-2273 | 209115 |
| 8859562 | August 4, 2031 | Method of use | U-2830 | 209115 |
| 10130636 | August 17, 2035 | Method of use | U-2273 | 209115 |
| 10130636 | August 17, 2035 | Method of use | U-2101 | 209115 |
| 10130636 | August 17, 2035 | Method of use | U-2012 | 209115 |
| 10130636 | August 17, 2035 | Method of use | U-2830 | 209115 |
| 9987285 | August 17, 2035 | Drug product | None | 209115 |
Rubraca exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-982 | New indication | December 17, 2028 | 209115 |
Rubraca NDC codes
Questions
Is there a generic for Rubraca?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rubraca (rucaparib camsylate). The Orange Book shows its last listed patent expires August 17, 2035 and its last listed exclusivity ends December 17, 2028.
What is the generic name for Rubraca?
The active ingredient in Rubraca is rucaparib camsylate, per the FDA Orange Book.
When does the Rubraca patent expire?
The last patent listed for Rubraca in the Orange Book expires August 17, 2035. 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.