Orange Book product · Brand (NDA)
VIZZ
ACECLIDINE HYDROCHLORIDE
At a glance
Jul 31, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 31, 2025
11 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jul 31, 2030
in 4 yr 2 mo
Patent 10052313 expires
Listed drug product patent expiration.
Mar 24, 2034
in 7 yr 11 mo
Patent 11179328 expires
Listed method-of-use patent (U-3741) expiration.
Mar 24, 2034
in 7 yr 11 mo
Patent 9844537 expires
Listed drug product patent expiration.
Mar 24, 2034
in 7 yr 11 mo
Patent 12128036 expires
Listed method-of-use patent (U-3741) expiration.
Oct 08, 2039
in 13 yr 6 mo
Patent 12533347 expires
Listed method-of-use patent (U-3741) expiration.
Oct 08, 2039
in 13 yr 6 mo
Patent 12414942 expires
Listed method-of-use patent (U-3741) expiration.
Mar 15, 2044
in 18 yr
Pharmaceutical detail
Active ingredient
ACECLIDINE HYDROCHLORIDE
Strength
EQ 1.44% BASE
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 218585
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)
Jul 31, 2030
in 4 yr 2 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10052313 | Mar 24, 2034 | in 7 yr 11 mo | ProductU-3741 |
| 11179328 | Mar 24, 2034 | in 7 yr 11 mo | U-3741 |
| 9844537 | Mar 24, 2034 | in 7 yr 11 mo | ProductU-3741 |
| 12128036 | Oct 08, 2039 | in 13 yr 6 mo | U-3741 |
| 12533347 | Oct 08, 2039 | in 13 yr 6 mo | U-3741 |
| 12414942 | Mar 15, 2044 | in 18 yr | U-3741 |
