Orange Book product · Brand (NDA)
OHTUVAYRE
ENSIFENTRINE
At a glance
Jun 26, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 26, 2024
2 yr ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jun 26, 2029
in 3 yr 1 mo
Patent 9062047 expires
Listed drug substance patent expiration.
Aug 21, 2031
in 5 yr 3 mo
Patent 10945950 expires
Listed drug product patent expiration.
Sep 15, 2035
in 9 yr 5 mo
Patent 9956171 expires
Listed drug product patent expiration.
Sep 15, 2035
in 9 yr 5 mo
Patent 12409180 expires
Listed drug product patent expiration.
Feb 20, 2043
in 16 yr 11 mo
Patent 12251384 expires
Listed drug product patent expiration.
Jun 25, 2044
in 18 yr 3 mo
Pharmaceutical detail
Active ingredient
ENSIFENTRINE
Strength
3MG/2.5ML
Dosage form
SUSPENSION
Route
INHALATION
TE code
Not listed
Application
NDA 217389
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)
Jun 26, 2029
in 3 yr 1 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9062047 | Aug 21, 2031 | in 5 yr 3 mo | SubstanceU-3962 |
| 10945950 | Sep 15, 2035 | in 9 yr 5 mo | Product |
| 9956171 | Sep 15, 2035 | in 9 yr 5 mo | ProductU-3962 |
| 12409180 | Feb 20, 2043 | in 16 yr 11 mo | Product |
| 12251384 | Jun 25, 2044 | in 18 yr 3 mo | Product |
