Orange Book product · Brand (NDA)
LICART
DICLOFENAC EPOLAMINE
At a glance
Dec 19, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 19, 2018
7 yr 7 mo ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Mar 27, 2029
in 2 yr 10 mo
Patent 11344520 expires
Listed method-of-use patent (U-3393) expiration.
Feb 20, 2035
in 8 yr 10 mo
Patent 11351133 expires
Listed method-of-use patent (U-3393) expiration.
Feb 20, 2035
in 8 yr 10 mo
Pharmaceutical detail
Active ingredient
DICLOFENAC EPOLAMINE
Strength
1.3%
Dosage form
SYSTEM
Route
TOPICAL
TE code
Not listed
Application
NDA 206976
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)
- NPPNew patient population exclusivity (3 years)
Mar 27, 2029
in 2 yr 10 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11344520 | Feb 20, 2035 | in 8 yr 10 mo | U-3393 |
| 11351133 | Feb 20, 2035 | in 8 yr 10 mo | U-3393 |
