FDA Orange Book
Is there a generic for Zelboraf?
Zelboraf contains vemurafenib. 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 Zelboraf (vemurafenib). The Orange Book shows its last listed patent expires June 6, 2032.
Run it in Rivvi
Map Zelboraf and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Zelboraf products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 240MG | Marketed (Rx) | None | 0 | None |
NDA 202429, held by HOFFMANN LA ROCHE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zelboraf patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8143271 | June 21, 2026 | Drug substance, Drug product | None | 202429 |
| 8470818 | August 2, 2026 | Method of use | U-2164 | 202429 |
| 8470818 | August 2, 2026 | Method of use | U-1418 | 202429 |
| 7504509 | October 22, 2026 | Drug substance, Drug product | None | 202429 |
| 7863288 | June 20, 2029 | Drug substance, Drug product | None | 202429 |
| 8741920 | July 27, 2030 | Drug substance, Drug product | None | 202429 |
| 9447089 | June 6, 2032 | Drug product | None | 202429 |
Zelboraf NDC codes
Questions
Is there a generic for Zelboraf?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zelboraf (vemurafenib). The Orange Book shows its last listed patent expires June 6, 2032.
What is the generic name for Zelboraf?
The active ingredient in Zelboraf is vemurafenib, per the FDA Orange Book.
When does the Zelboraf patent expire?
The last patent listed for Zelboraf in the Orange Book expires June 6, 2032. 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.