FDA Orange Book · active-ingredient family
Navepegritide
Navepegritide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:YUVIWEL · NDA 219164
1
Brand (NDA)
0
Generics (ANDA)
12
Listed patents
6
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| YUVIWELRLD×3 | ASCENDIS | NDA 219164 | — | Feb 27, 2026 |
Marketing exclusivity (6)
- NCENew chemical entity exclusivity (5 years)
Feb 27, 2031
in 4 yr 9 mo
- ODE-516Orphan-drug exclusivity (7 years)
Feb 27, 2033
in 6 yr 10 mo
- NCENew chemical entity exclusivity (5 years)
Feb 27, 2031
in 4 yr 9 mo
- ODE-516Orphan-drug exclusivity (7 years)
Feb 27, 2033
in 6 yr 10 mo
- NCENew chemical entity exclusivity (5 years)
Feb 27, 2031
in 4 yr 9 mo
- ODE-516Orphan-drug exclusivity (7 years)
Feb 27, 2033
in 6 yr 10 mo
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8906847 | Apr 30, 2031 | in 4 yr 11 mo | SubstanceProductU-4425 |
| 12239689 | Jan 05, 2037 | in 10 yr 8 mo | U-4425 |
| 12156917 | Jan 05, 2037 | in 10 yr 8 mo | U-4425 |
| 10835578 | Jan 05, 2037 | in 10 yr 8 mo | SubstanceProductU-4425 |
| 11154593 | Jan 05, 2037 | in 10 yr 8 mo | SubstanceProductU-4425 |
| 12083182 | Jan 05, 2037 | in 10 yr 8 mo | U-4425 |
| 11311604 | Jan 05, 2037 | in 10 yr 8 mo | SubstanceProductU-4425 |
| 11389511 | Jan 05, 2037 | in 10 yr 8 mo | ProductU-4425 |
| 11224661 | Jan 05, 2037 | in 10 yr 8 mo | SubstanceProduct |
| 11413351 | Jan 05, 2037 | in 10 yr 8 mo | SubstanceProduct |
| 11389510 | Jan 05, 2037 | in 10 yr 8 mo | SubstanceProduct |
| 12377133 | Nov 12, 2042 | in 16 yr 8 mo | ProductU-4425 |
Navepegritide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
