FDA Orange Book
Is there a generic for Braftovi?
Braftovi contains encorafenib. 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 Braftovi (encorafenib). The Orange Book shows its last listed patent expires August 5, 2033 and its last listed exclusivity ends October 11, 2030.
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Braftovi 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 |
| capsule, oral | 75MG | Marketed (Rx) | None | 0 | None |
NDA 210496, held by ARRAY BIOPHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Braftovi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8946250 | July 23, 2029 | Drug substance, Drug product | None | 210496 |
| 8541575 | February 26, 2030 | Drug substance, Drug product | U-2335 | 210496 |
| 8541575 | February 26, 2030 | Drug substance, Drug product | U-4440 | 210496 |
| 8541575 | February 26, 2030 | Drug substance, Drug product | U-2803 | 210496 |
| 8541575 | February 26, 2030 | Drug substance, Drug product | U-2802 | 210496 |
| 8541575 | February 26, 2030 | Drug substance, Drug product | U-3738 | 210496 |
| 8541575 | February 26, 2030 | Drug substance, Drug product | U-4051 | 210496 |
| RE49556 | February 27, 2030 | Drug substance, Drug product | None | 210496 |
| 9850230 | August 27, 2030 | Method of use | U-2334 | 210496 |
| 10005761 | August 27, 2030 | Method of use | U-2335 | 210496 |
| 9850229 | August 27, 2030 | Method of use | U-2337 | 210496 |
| 9593099 | August 27, 2030 | Drug substance | None | 210496 |
| 9593100 | August 27, 2030 | Drug product | None | 210496 |
| 10005761 | August 27, 2030 | Method of use | U-4440 | 210496 |
| 9850230 | August 27, 2030 | Method of use | U-4440 | 210496 |
| 9850230 | August 27, 2030 | Method of use | U-2802 | 210496 |
| 9850230 | August 27, 2030 | Method of use | U-2803 | 210496 |
| 10005761 | August 27, 2030 | Method of use | U-2802 | 210496 |
| 10005761 | August 27, 2030 | Method of use | U-2803 | 210496 |
| 10005761 | August 27, 2030 | Method of use | U-3738 | 210496 |
| 9850230 | August 27, 2030 | Method of use | U-3738 | 210496 |
| 9850230 | August 27, 2030 | Method of use | U-4051 | 210496 |
| 10005761 | August 27, 2030 | Method of use | U-4051 | 210496 |
| 9314464 | July 4, 2031 | Method of use | U-2336 | 210496 |
| 9314464 | July 4, 2031 | Method of use | U-4440 | 210496 |
| 9314464 | July 4, 2031 | Method of use | U-2802 | 210496 |
| 9314464 | July 4, 2031 | Method of use | U-2803 | 210496 |
| 9314464 | July 4, 2031 | Method of use | U-3738 | 210496 |
| 9314464 | July 4, 2031 | Method of use | U-4051 | 210496 |
| 9763941 | November 21, 2032 | Method of use | U-2335 | 210496 |
| 9387208 | November 21, 2032 | Drug product | None | 210496 |
| 10258622 | November 21, 2032 | Method of use | U-4439 | 210496 |
| 10258622 | November 21, 2032 | Method of use | U-2802 | 210496 |
| 10258622 | November 21, 2032 | Method of use | U-4051 | 210496 |
| 9474754 | August 5, 2033 | Method of use | U-4440 | 210496 |
| 9474754 | August 5, 2033 | Method of use | U-2802 | 210496 |
| 9474754 | August 5, 2033 | Method of use | U-4051 | 210496 |
Braftovi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-928 | New indication | October 11, 2026 | 210496 |
| I-957 | New indication | December 20, 2027 | 210496 |
| I-997 | New indication | February 24, 2029 | 210496 |
| ODE-445 | Orphan drug exclusivity | October 11, 2030 | 210496 |
Braftovi NDC codes
Questions
Is there a generic for Braftovi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Braftovi (encorafenib). The Orange Book shows its last listed patent expires August 5, 2033 and its last listed exclusivity ends October 11, 2030.
What is the generic name for Braftovi?
The active ingredient in Braftovi is encorafenib, per the FDA Orange Book.
When does the Braftovi patent expire?
The last patent listed for Braftovi in the Orange Book expires August 5, 2033. 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.