FDA Orange Book
Is there a generic for Tafinlar?
Tafinlar contains dabrafenib. 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 Tafinlar (dabrafenib). The Orange Book shows its last listed patent expires December 29, 2038 and its last listed exclusivity ends September 16, 2030.
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Tafinlar products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 50MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 75MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, for suspension, oral | EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
NDA 202806, 217514, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tafinlar patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9233956 | May 4, 2029 | Method of use | U-2032 | 202806 |
| 9233956 | May 4, 2029 | Method of use | U-2296 | 202806 |
| 9233956 | May 4, 2029 | Method of use | U-2031 | 202806 |
| 9233956 | May 4, 2029 | Method of use | U-1811 | 202806 |
| 9233956*PED | November 4, 2029 | Method of use | None | 202806 |
| 7994185 | January 20, 2030 | Drug substance, Drug product | U-2296 | 202806 |
| 7994185 | January 20, 2030 | Drug substance, Drug product | U-2032 | 202806 |
| 7994185 | January 20, 2030 | Drug substance, Drug product | U-1406 | 202806 |
| 8415345 | January 20, 2030 | Drug substance, Drug product | U-2032 | 202806 |
| 8415345 | January 20, 2030 | Drug substance, Drug product | U-2031 | 202806 |
| 8415345 | January 20, 2030 | Drug substance, Drug product | U-1406 | 202806 |
| 7994185 | January 20, 2030 | Drug substance, Drug product | U-2031 | 202806 |
| 8415345 | January 20, 2030 | Drug substance, Drug product | U-2296 | 202806 |
| 8415345 | January 20, 2030 | Drug substance, Drug product | None | 217514 |
| 7994185 | January 20, 2030 | Drug substance, Drug product | None | 217514 |
| 7994185*PED | July 20, 2030 | Method of use | None | 202806 |
| 8415345*PED | July 20, 2030 | Method of use | None | 202806 |
| 8703781 | October 15, 2030 | Drug substance, Drug product | U-2296 | 202806 |
| 8703781 | October 15, 2030 | Drug substance, Drug product | U-1713 | 202806 |
| 8952018 | October 15, 2030 | Method of use | U-2027 | 202806 |
| 8703781 | October 15, 2030 | Drug substance, Drug product | U-2032 | 202806 |
| 8703781 | October 15, 2030 | Drug substance, Drug product | U-2298 | 202806 |
| 8703781 | October 15, 2030 | Drug substance, Drug product | U-3565 | 217514 |
| 8952018*PED | April 15, 2031 | Method of use | None | 202806 |
| 8703781*PED | April 15, 2031 | Method of use | None | 202806 |
| 10869869 | August 30, 2033 | Method of use | U-3185 | 202806 |
| 10869869*PED | February 28, 2034 | Method of use | None | 202806 |
| 11504333 | June 29, 2038 | Drug product | None | 217514 |
| 11504333*PED | December 29, 2038 | Method of use | None | 217514 |
Tafinlar exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-908 | New indication | March 16, 2026 | 202806 |
| NP | New product | March 16, 2026 | 217514 |
| PED | Pediatric exclusivity | September 16, 2026 | 202806 |
| ODE-428 | Orphan drug exclusivity | March 16, 2030 | 202806 |
| PED | Pediatric exclusivity | September 16, 2030 | 202806 |
Tafinlar NDC codes
Questions
Is there a generic for Tafinlar?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tafinlar (dabrafenib). The Orange Book shows its last listed patent expires December 29, 2038 and its last listed exclusivity ends September 16, 2030.
What is the generic name for Tafinlar?
The active ingredient in Tafinlar is dabrafenib, per the FDA Orange Book.
When does the Tafinlar patent expire?
The last patent listed for Tafinlar in the Orange Book expires December 29, 2038. 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.