Orange Book product · Brand (NDA)
SCENESSE
AFAMELANOTIDE
Brand (NDA)NDA 210797RX CLIVUNEL INC
At a glance
Oct 08, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 08, 2019
6 yr 10 mo ago
Today
Exclusivity ends · ODE-270
Orphan-drug exclusivity (7 years)
Oct 08, 2026
in 4 mo
Patent 8334265 expires
Listed method-of-use patent (U-2638) expiration.
Jan 20, 2033
in 6 yr 8 mo
Pharmaceutical detail
Active ingredient
AFAMELANOTIDE
Strength
16MG
Dosage form
IMPLANT
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 210797
Product number
001
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 (1)
- ODE-270Orphan-drug exclusivity (7 years)
Oct 08, 2026
in 4 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8334265 | Jan 20, 2033 | in 6 yr 8 mo | U-2638 |
