FDA Orange Book
Is there a generic for Aqvesme?
Aqvesme contains mitapivat. 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 Aqvesme (mitapivat). The Orange Book shows its last listed patent expires July 31, 2041 and its last listed exclusivity ends December 23, 2032.
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Aqvesme products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
NDA 216196, held by AGIOS PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Aqvesme patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10632114 | May 3, 2032 | Method of use | U-4391 | 216196 |
| 9682080 | May 3, 2032 | Method of use | U-4392 | 216196 |
| 9193701 | October 26, 2032 | Method of use | U-4393 | 216196 |
| RE49582 | April 11, 2035 | Drug substance, Drug product | None | 216196 |
| 11254652 | November 21, 2038 | Drug substance, Drug product | None | 216196 |
| 11878049 | July 31, 2041 | Method of use | U-4390 | 216196 |
Aqvesme exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | February 17, 2027 | 216196 |
| NP | New product | December 23, 2028 | 216196 |
| ODE-522 | Orphan drug exclusivity | December 23, 2032 | 216196 |
Aqvesme NDC codes
Questions
Is there a generic for Aqvesme?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Aqvesme (mitapivat). The Orange Book shows its last listed patent expires July 31, 2041 and its last listed exclusivity ends December 23, 2032.
What is the generic name for Aqvesme?
The active ingredient in Aqvesme is mitapivat, per the FDA Orange Book.
When does the Aqvesme patent expire?
The last patent listed for Aqvesme in the Orange Book expires July 31, 2041. 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.