FDA Orange Book · active-ingredient family
Voxelotor
Voxelotor is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:OXBRYTA · NDA 213137
2
Brand (NDA)
0
Generics (ANDA)
11
Listed patents
5
Exclusivity periods
Brand (NDA) products · tablet, tablet, for suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OXBRYTARLD×2 | GLOBAL BLOOD THERAPS | NDA 213137 | — | Oct 14, 2022 | |
| OXBRYTARLD | GLOBAL BLOOD THERAPS | NDA 216157 | — | Dec 17, 2021 |
Marketing exclusivity (5)
- ODE*FDA marketing exclusivity
Nov 25, 2026
in 5 mo
- ODE-394Orphan-drug exclusivity (7 years)
Dec 17, 2028
in 2 yr 6 mo
- ODE-394Orphan-drug exclusivity (7 years)
Dec 17, 2028
in 2 yr 6 mo
- ODE-281Orphan-drug exclusivity (7 years)
Nov 25, 2026
in 5 mo
- ODE-394Orphan-drug exclusivity (7 years)
Dec 17, 2028
in 2 yr 6 mo
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10034879 | Dec 28, 2032 | in 6 yr 7 mo | SubstanceProduct |
| 10017491 | Dec 28, 2032 | in 6 yr 7 mo | Product |
| 10806733 | Dec 28, 2032 | in 6 yr 7 mo | Substance |
| 9018210 | Nov 25, 2033 | in 7 yr 7 mo | SubstanceProduct |
| 9248199 | Jan 29, 2034 | in 7 yr 9 mo | U-2676 |
| 11452720 | Feb 06, 2035 | in 8 yr 9 mo | U-3459 |
| 10722502 | Feb 06, 2035 | in 8 yr 9 mo | Product |
| 9447071 | Feb 06, 2035 | in 8 yr 9 mo | SubstanceProduct |
| 11020382 | Dec 02, 2036 | in 10 yr 7 mo | U-3133 |
| 11944612 | Dec 02, 2036 | in 10 yr 7 mo | U-3893 |
| 10493035 | Oct 12, 2037 | in 11 yr 6 mo | Product |
Voxelotor — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
