Orange Book product · Brand (NDA)
CARDAMYST
ETRIPAMIL
At a glance
Dec 12, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 12, 2025
6 mo ago
Today
Patent 10010522 expires
Listed method-of-use patent (U-38) expiration.
Jun 19, 2028
in 2 yr
Patent 10010523 expires
Listed drug substance patent expiration.
Jun 19, 2028
in 2 yr
Patent 9227918 expires
Listed drug product patent expiration.
Jun 19, 2028
in 2 yr
Patent 9463179 expires
Listed method-of-use patent (U-4370) expiration.
Jun 19, 2028
in 2 yr
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Dec 12, 2030
in 4 yr 7 mo
Patent 10117848 expires
Listed drug product patent expiration.
Apr 13, 2036
in 10 yr
Patent 12257224 expires
Listed method-of-use patent (U-4370) expiration.
Jul 15, 2042
in 16 yr 4 mo
Pharmaceutical detail
Active ingredient
ETRIPAMIL
Strength
70MG
Dosage form
SPRAY
Route
NASAL
TE code
Not listed
Application
NDA 218571
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 12, 2030
in 4 yr 7 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10010522 | Jun 19, 2028 | in 2 yr | U-38 |
| 10010523 | Jun 19, 2028 | in 2 yr | Substance |
| 9227918 | Jun 19, 2028 | in 2 yr | Product |
| 9463179 | Jun 19, 2028 | in 2 yr | U-4370 |
| 10117848 | Apr 13, 2036 | in 10 yr | ProductU-4370 |
| 12257224 | Jul 15, 2042 | in 16 yr 4 mo | U-4370 |
