FDA Orange Book
Is there a generic for Ayvakit?
Ayvakit contains avapritinib. 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 Ayvakit (avapritinib). The Orange Book shows its last listed patent expires March 8, 2042 and its last listed exclusivity ends May 22, 2030.
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Ayvakit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 200MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 25MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 300MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 50MG | Marketed (Rx) | None | 0 | None |
NDA 212608, held by BLUEPRINT MEDICINES CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ayvakit patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9200002 | October 15, 2034 | Drug substance, Drug product | U-3168 | 212608 |
| 9944651 | October 15, 2034 | Drug substance, Drug product | U-3168 | 212608 |
| 9994575 | October 15, 2034 | Drug substance, Drug product | U-3168 | 212608 |
| 9944651 | October 15, 2034 | Drug substance, Drug product | U-3506 | 212608 |
| 9994575 | October 15, 2034 | Drug substance, Drug product | U-3506 | 212608 |
| 9200002 | October 15, 2034 | Drug substance, Drug product | U-3506 | 212608 |
| 11827642 | October 15, 2034 | Drug substance, Drug product | U-3506 | 212608 |
| 9944651 | October 15, 2034 | Drug substance, Drug product | U-2726 | 212608 |
| 9994575 | October 15, 2034 | Drug substance, Drug product | U-2726 | 212608 |
| 9200002 | October 15, 2034 | Drug substance, Drug product | U-2726 | 212608 |
| 11999744 | April 10, 2040 | Method of use | U-3168 | 212608 |
| 11999744 | April 10, 2040 | Method of use | U-3506 | 212608 |
| 12252494 | April 10, 2040 | Method of use | U-3506 | 212608 |
| 11964980 | April 10, 2040 | Drug substance, Drug product | None | 212608 |
| 12060354 | March 8, 2042 | Method of use | U-2726 | 212608 |
Ayvakit exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-912 | New indication | May 22, 2026 | 212608 |
| ODE-366 | Orphan drug exclusivity | January 9, 2027 | 212608 |
| ODE-356 | Orphan drug exclusivity | June 16, 2028 | 212608 |
| ODE-434 | Orphan drug exclusivity | May 22, 2030 | 212608 |
Ayvakit NDC codes
Questions
Is there a generic for Ayvakit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ayvakit (avapritinib). The Orange Book shows its last listed patent expires March 8, 2042 and its last listed exclusivity ends May 22, 2030.
What is the generic name for Ayvakit?
The active ingredient in Ayvakit is avapritinib, per the FDA Orange Book.
When does the Ayvakit patent expire?
The last patent listed for Ayvakit in the Orange Book expires March 8, 2042. 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.