Orange Book product · Brand (NDA)
CAMZYOS
MAVACAMTEN
At a glance
Apr 28, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 28, 2022
4 yr 2 mo ago
Exclusivity ends · M-297
New use / labeling-change exclusivity (3 years)
Jun 15, 2026
4 d ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Apr 28, 2027
in 10 mo
Exclusivity ends · ODE-398
Orphan-drug exclusivity (7 years)
Apr 28, 2029
in 2 yr 11 mo
Patent 9585883 expires
Listed method-of-use patent (U-3373) expiration.
Jun 19, 2034
in 8 yr 1 mo
Patent RE50050 expires
Listed drug substance patent expiration.
Apr 28, 2036
in 10 yr
Pharmaceutical detail
Active ingredient
MAVACAMTEN
Strength
15MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 214998
Product number
004
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (3)
- M-297New use / labeling-change exclusivity (3 years)
Jun 15, 2026
4 d ago
- NCENew chemical entity exclusivity (5 years)
Apr 28, 2027
in 10 mo
- ODE-398Orphan-drug exclusivity (7 years)
Apr 28, 2029
in 2 yr 11 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9585883 | Jun 19, 2034 | in 8 yr 1 mo | U-3373 |
| RE50050 | Apr 28, 2036 | in 10 yr | SubstanceProduct |
