Orange Book product · Brand (NDA)
ZORVOLEX
DICLOFENAC
At a glance
Oct 18, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 18, 2013
12 yr 10 mo ago
Today
Patent 8679544 expires
Listed drug product patent expiration.
Apr 23, 2030
in 3 yr 11 mo
Patent 8999387 expires
Listed method-of-use patent (U-55) expiration.
Apr 23, 2030
in 3 yr 11 mo
Patent 9017721 expires
Listed drug product patent expiration.
Apr 23, 2030
in 3 yr 11 mo
Patent 9173854 expires
Listed drug product patent expiration.
Apr 23, 2030
in 3 yr 11 mo
Patent 9180095 expires
Listed method-of-use patent (U-55) expiration.
Apr 23, 2030
in 3 yr 11 mo
Patent 9180096 expires
Listed drug product patent expiration.
Apr 23, 2030
in 3 yr 11 mo
Patent 9186328 expires
Listed method-of-use patent (U-55) expiration.
Apr 23, 2030
in 3 yr 11 mo
Pharmaceutical detail
Active ingredient
DICLOFENAC
Strength
35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 204592
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8679544 | Apr 23, 2030 | in 3 yr 11 mo | Product |
| 8999387 | Apr 23, 2030 | in 3 yr 11 mo | U-55 |
| 9017721 | Apr 23, 2030 | in 3 yr 11 mo | Product |
| 9173854 | Apr 23, 2030 | in 3 yr 11 mo | Product |
| 9180095 | Apr 23, 2030 | in 3 yr 11 mo | U-55 |
| 9180096 | Apr 23, 2030 | in 3 yr 11 mo | Product |
| 9186328 | Apr 23, 2030 | in 3 yr 11 mo | U-55 |
