FDA Orange Book · active-ingredient family
Mitapivat sulfate
Mitapivat sulfate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:AQVESME · NDA 216196
1
Brand (NDA)
0
Generics (ANDA)
9
Listed patents
9
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AQVESMERLD×4 | AGIOS PHARMS INC | NDA 216196 | — | Dec 23, 2025 |
Marketing exclusivity (9)
- NCENew chemical entity exclusivity (5 years)
Feb 17, 2027
in 8 mo
- NPNew product exclusivity (3 years)
Dec 23, 2028
in 2 yr 7 mo
- ODE-522Orphan-drug exclusivity (7 years)
Dec 23, 2032
in 6 yr 7 mo
- NCENew chemical entity exclusivity (5 years)
Feb 17, 2027
in 8 mo
- ODE-392Orphan-drug exclusivity (7 years)
Feb 17, 2029
in 2 yr 8 mo
- NCENew chemical entity exclusivity (5 years)
Feb 17, 2027
in 8 mo
- ODE-392Orphan-drug exclusivity (7 years)
Feb 17, 2029
in 2 yr 8 mo
- NCENew chemical entity exclusivity (5 years)
Feb 17, 2027
in 8 mo
- ODE-392Orphan-drug exclusivity (7 years)
Feb 17, 2029
in 2 yr 8 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10632114 | May 03, 2032 | in 6 yr | U-4391 |
| 9682080 | May 03, 2032 | in 6 yr | U-4392 |
| 9980961 | May 03, 2032 | in 6 yr | U-3319 |
| 9193701 | Oct 26, 2032 | in 6 yr 5 mo | U-4393 |
| 11793806 | Apr 12, 2033 | in 6 yr 11 mo | U-3320 |
| RE49582 | Apr 11, 2035 | in 8 yr 11 mo | SubstanceProduct |
| 11234976 | Oct 11, 2038 | in 12 yr 6 mo | U-3321 |
| 11254652 | Nov 21, 2038 | in 12 yr 7 mo | SubstanceProduct |
| 11878049 | Jul 31, 2041 | in 15 yr 4 mo | U-4390 |
Mitapivat sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
