FDA Orange Book
Is there a generic for Tabrecta?
Tabrecta contains capmatinib. 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 Tabrecta (capmatinib). The Orange Book shows its last listed patent expires July 22, 2035 and its last listed exclusivity ends May 6, 2027.
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Tabrecta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 150MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 200MG BASE | Marketed (Rx) | None | 0 | None |
NDA 213591, held by NOVARTIS PHARMACEUTICAL CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tabrecta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12084449 | November 19, 2027 | Method of use | U-2813 | 213591 |
| 8461330 | November 19, 2027 | Drug substance, Drug product | None | 213591 |
| 8901123 | May 20, 2029 | Method of use | U-2813 | 213591 |
| 8420645 | June 5, 2031 | Drug substance, Drug product | None | 213591 |
| 7767675 | November 19, 2032 | Drug substance, Drug product | None | 213591 |
| 10596178 | July 22, 2035 | Drug product | None | 213591 |
| 12208101 | July 22, 2035 | Drug product | None | 213591 |
Tabrecta exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-291 | Orphan drug exclusivity | May 6, 2027 | 213591 |
Tabrecta NDC codes
Questions
Is there a generic for Tabrecta?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tabrecta (capmatinib). The Orange Book shows its last listed patent expires July 22, 2035 and its last listed exclusivity ends May 6, 2027.
What is the generic name for Tabrecta?
The active ingredient in Tabrecta is capmatinib, per the FDA Orange Book.
When does the Tabrecta patent expire?
The last patent listed for Tabrecta in the Orange Book expires July 22, 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.