Orange Book product · Brand (NDA)
TRYPTYR
ACOLTREMON
At a glance
May 28, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 28, 2025
1 yr 1 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 28, 2030
in 4 yr
Patent 10028920 expires
Listed method-of-use patent (U-1900) expiration.
Sep 08, 2031
in 5 yr 4 mo
Patent 9095609 expires
Listed drug product patent expiration.
Sep 08, 2031
in 5 yr 4 mo
Patent 9433679 expires
Listed method-of-use patent (U-1900) expiration.
Sep 08, 2031
in 5 yr 4 mo
Patent 11850221 expires
Listed drug product patent expiration.
Dec 16, 2042
in 16 yr 9 mo
Patent 12336971 expires
Listed method-of-use patent (U-1900) expiration.
Dec 16, 2042
in 16 yr 9 mo
Pharmaceutical detail
Active ingredient
ACOLTREMON
Strength
0.003%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 217370
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)
May 28, 2030
in 4 yr
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10028920 | Sep 08, 2031 | in 5 yr 4 mo | U-1900 |
| 9095609 | Sep 08, 2031 | in 5 yr 4 mo | ProductU-1900 |
| 9433679 | Sep 08, 2031 | in 5 yr 4 mo | U-1900 |
| 11850221 | Dec 16, 2042 | in 16 yr 9 mo | ProductU-1900 |
| 12336971 | Dec 16, 2042 | in 16 yr 9 mo | U-1900 |
