Orange Book product · Brand (NDA)
OXBRYTA
VOXELOTOR
At a glance
Dec 17, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
12
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 17, 2021
4 yr 7 mo ago
Today
Exclusivity ends · ODE*
FDA marketing exclusivity
Nov 25, 2026
in 5 mo
Exclusivity ends · ODE-394
Orphan-drug exclusivity (7 years)
Dec 17, 2028
in 2 yr 6 mo
Patent 10017491 expires
Listed drug product patent expiration.
Dec 28, 2032
in 6 yr 7 mo
Patent 10034879 expires
Listed drug substance patent expiration.
Dec 28, 2032
in 6 yr 7 mo
Patent 10806733 expires
Listed drug substance patent expiration.
Dec 28, 2032
in 6 yr 7 mo
Patent 9018210 expires
Listed drug substance patent expiration.
Nov 25, 2033
in 7 yr 7 mo
Patent 9248199 expires
Listed method-of-use patent (U-2676) expiration.
Jan 29, 2034
in 7 yr 9 mo
Patent 9248199 expires
Listed method-of-use patent (U-2715) expiration.
Jan 29, 2034
in 7 yr 9 mo
Patent 10722502 expires
Listed drug product patent expiration.
Feb 06, 2035
in 8 yr 9 mo
Patent 11452720 expires
Listed method-of-use patent (U-3459) expiration.
Feb 06, 2035
in 8 yr 9 mo
Patent 9447071 expires
Listed drug substance patent expiration.
Feb 06, 2035
in 8 yr 9 mo
Patent 11020382 expires
Listed method-of-use patent (U-3133) expiration.
Dec 02, 2036
in 10 yr 7 mo
Patent 11020382 expires
Listed method-of-use patent (U-3134) expiration.
Dec 02, 2036
in 10 yr 7 mo
Patent 11944612 expires
Listed method-of-use patent (U-3893) expiration.
Dec 02, 2036
in 10 yr 7 mo
Pharmaceutical detail
Active ingredient
VOXELOTOR
Strength
300MG
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 216157
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- ODE*FDA marketing exclusivity
Nov 25, 2026
in 5 mo
- ODE-394Orphan-drug exclusivity (7 years)
Dec 17, 2028
in 2 yr 6 mo
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10017491 | Dec 28, 2032 | in 6 yr 7 mo | Product |
| 10034879 | Dec 28, 2032 | in 6 yr 7 mo | SubstanceProduct |
| 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 |
| 9248199 | Jan 29, 2034 | in 7 yr 9 mo | U-2715 |
| 10722502 | Feb 06, 2035 | in 8 yr 9 mo | Product |
| 11452720 | Feb 06, 2035 | in 8 yr 9 mo | U-3459 |
| 9447071 | Feb 06, 2035 | in 8 yr 9 mo | SubstanceProduct |
| 11020382 | Dec 02, 2036 | in 10 yr 7 mo | U-3133 |
| 11020382 | Dec 02, 2036 | in 10 yr 7 mo | U-3134 |
| 11944612 | Dec 02, 2036 | in 10 yr 7 mo | U-3893 |
