Orange Book product · Brand (NDA)
MYQORZO
AFICAMTEN
At a glance
Dec 19, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 19, 2025
6 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Dec 19, 2030
in 4 yr 7 mo
Patent 10836755 expires
Listed drug substance patent expiration.
Jan 18, 2039
in 12 yr 9 mo
Patent 12370179 expires
Listed method-of-use patent (U-4371) expiration.
Jul 15, 2042
in 16 yr 4 mo
Pharmaceutical detail
Active ingredient
AFICAMTEN
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 219083
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)
- NCENew chemical entity exclusivity (5 years)
Dec 19, 2030
in 4 yr 7 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10836755 | Jan 18, 2039 | in 12 yr 9 mo | SubstanceProductU-4371 |
| 12370179 | Jul 15, 2042 | in 16 yr 4 mo | U-4371 |
