FDA Orange Book
Is there a generic for Gavreto?
Gavreto contains pralsetinib. 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 Gavreto (pralsetinib). The Orange Book shows its last listed patent expires April 19, 2043 and its last listed exclusivity ends December 1, 2027.
Run it in Rivvi
Map Gavreto 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.
Gavreto products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | None | 0 | None |
NDA 213721, held by RIGEL PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Gavreto patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10030005 | November 1, 2036 | Drug substance, Drug product | U-2952 | 213721 |
| 10030005 | November 1, 2036 | Drug substance, Drug product | U-3002 | 213721 |
| 12655128 | November 1, 2036 | Drug substance, Drug product | None | 213721 |
| 11273160 | April 3, 2039 | Method of use | U-2952 | 213721 |
| 12539303 | April 3, 2039 | Method of use | U-2828 | 213721 |
| 11872192 | April 3, 2039 | Method of use | U-2952 | 213721 |
| 11963958 | April 3, 2039 | Method of use | U-2828 | 213721 |
| 12448366 | July 7, 2042 | Drug substance | None | 213721 |
| 12692251 | April 19, 2043 | Drug product | None | 213721 |
Gavreto exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-318 | Orphan drug exclusivity | September 4, 2027 | 213721 |
| ODE-340 | Orphan drug exclusivity | December 1, 2027 | 213721 |
| ODE-341 | Orphan drug exclusivity | December 1, 2027 | 213721 |
Gavreto NDC codes
Questions
Is there a generic for Gavreto?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Gavreto (pralsetinib). The Orange Book shows its last listed patent expires April 19, 2043 and its last listed exclusivity ends December 1, 2027.
What is the generic name for Gavreto?
The active ingredient in Gavreto is pralsetinib, per the FDA Orange Book.
When does the Gavreto patent expire?
The last patent listed for Gavreto in the Orange Book expires April 19, 2043. 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.