FDA Orange Book · active-ingredient family
Vosoritide
Vosoritide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:VOXZOGO · NDA 214938
1
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
12
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VOXZOGORLD×3 | BIOMARIN PHARM | NDA 214938 | — | Nov 19, 2021 |
Marketing exclusivity (12)
- NCENew chemical entity exclusivity (5 years)
Nov 19, 2026
in 5 mo
- NPPNew patient population exclusivity (3 years)
Oct 20, 2026
in 4 mo
- ODE-387Orphan-drug exclusivity (7 years)
Nov 19, 2028
in 2 yr 5 mo
- ODE-449Orphan-drug exclusivity (7 years)
Oct 20, 2030
in 4 yr 5 mo
- NCENew chemical entity exclusivity (5 years)
Nov 19, 2026
in 5 mo
- NPPNew patient population exclusivity (3 years)
Oct 20, 2026
in 4 mo
- ODE-387Orphan-drug exclusivity (7 years)
Nov 19, 2028
in 2 yr 5 mo
- ODE-449Orphan-drug exclusivity (7 years)
Oct 20, 2030
in 4 yr 5 mo
- NCENew chemical entity exclusivity (5 years)
Nov 19, 2026
in 5 mo
- NPPNew patient population exclusivity (3 years)
Oct 20, 2026
in 4 mo
- ODE-387Orphan-drug exclusivity (7 years)
Nov 19, 2028
in 2 yr 5 mo
- ODE-449Orphan-drug exclusivity (7 years)
Oct 20, 2030
in 4 yr 5 mo
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE48267 | May 20, 2030 | in 4 yr | U-3927 |
| 8198242 | Jun 11, 2035 | in 9 yr 1 mo | SubstanceProductU-3927 |
| 11911446 | Aug 01, 2036 | in 10 yr 3 mo | U-3927 |
| 11590204 | Aug 01, 2036 | in 10 yr 3 mo | ProductU-3927 |
| 12514906 | Aug 01, 2036 | in 10 yr 3 mo | ProductU-3927 |
| 10646550 | Aug 01, 2036 | in 10 yr 3 mo | ProductU-3927 |
| 9907834 | Aug 01, 2036 | in 10 yr 3 mo | Product |
| 12233106 | Jul 11, 2042 | in 16 yr 4 mo | U-3927 |
Vosoritide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
