Orange Book product · Brand (NDA)
YUVIWEL
NAVEPEGRITIDE
At a glance
Feb 27, 2026
Approved
Brand (NDA)
Application
Not listed
TE code
12
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 27, 2026
4 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Feb 27, 2031
in 4 yr 9 mo
Patent 8906847 expires
Listed drug substance patent expiration.
Apr 30, 2031
in 4 yr 11 mo
Exclusivity ends · ODE-516
Orphan-drug exclusivity (7 years)
Feb 27, 2033
in 6 yr 10 mo
Patent 10835578 expires
Listed drug substance patent expiration.
Jan 05, 2037
in 10 yr 8 mo
Patent 11154593 expires
Listed drug substance patent expiration.
Jan 05, 2037
in 10 yr 8 mo
Patent 11224661 expires
Listed drug substance patent expiration.
Jan 05, 2037
in 10 yr 8 mo
Patent 11311604 expires
Listed drug substance patent expiration.
Jan 05, 2037
in 10 yr 8 mo
Patent 11389510 expires
Listed drug substance patent expiration.
Jan 05, 2037
in 10 yr 8 mo
Patent 11389511 expires
Listed drug product patent expiration.
Jan 05, 2037
in 10 yr 8 mo
Patent 11413351 expires
Listed drug substance patent expiration.
Jan 05, 2037
in 10 yr 8 mo
Patent 12083182 expires
Listed method-of-use patent (U-4425) expiration.
Jan 05, 2037
in 10 yr 8 mo
Patent 12156917 expires
Listed method-of-use patent (U-4425) expiration.
Jan 05, 2037
in 10 yr 8 mo
Patent 12239689 expires
Listed method-of-use patent (U-4425) expiration.
Jan 05, 2037
in 10 yr 8 mo
Patent 12377133 expires
Listed drug product patent expiration.
Nov 12, 2042
in 16 yr 8 mo
Pharmaceutical detail
Active ingredient
NAVEPEGRITIDE
Strength
5.5MG/VIAL
Dosage form
POWDER
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 219164
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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)
- 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 |
| 10835578 | Jan 05, 2037 | in 10 yr 8 mo | SubstanceProductU-4425 |
| 11154593 | Jan 05, 2037 | in 10 yr 8 mo | SubstanceProductU-4425 |
| 11224661 | Jan 05, 2037 | in 10 yr 8 mo | SubstanceProduct |
| 11311604 | Jan 05, 2037 | in 10 yr 8 mo | SubstanceProductU-4425 |
| 11389510 | Jan 05, 2037 | in 10 yr 8 mo | SubstanceProduct |
| 11389511 | Jan 05, 2037 | in 10 yr 8 mo | ProductU-4425 |
| 11413351 | Jan 05, 2037 | in 10 yr 8 mo | SubstanceProduct |
| 12083182 | Jan 05, 2037 | in 10 yr 8 mo | U-4425 |
| 12156917 | Jan 05, 2037 | in 10 yr 8 mo | U-4425 |
| 12239689 | Jan 05, 2037 | in 10 yr 8 mo | U-4425 |
| 12377133 | Nov 12, 2042 | in 16 yr 8 mo | ProductU-4425 |
