FDA Orange Book · active-ingredient family
Diclofenac
Diclofenac is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ZORVOLEX · NDA 204592
1
Brand (NDA)
0
Generics (ANDA)
7
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZORVOLEXRLD×2 | ZYLA | NDA 204592 | — | Oct 18, 2013 |
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9186328 | Apr 23, 2030 | in 3 yr 11 mo | U-55 |
| 9180095 | Apr 23, 2030 | in 3 yr 11 mo | U-55 |
| 8999387 | Apr 23, 2030 | in 3 yr 11 mo | U-55 |
| 9180096 | Apr 23, 2030 | in 3 yr 11 mo | Product |
| 9017721 | Apr 23, 2030 | in 3 yr 11 mo | Product |
| 9173854 | Apr 23, 2030 | in 3 yr 11 mo | Product |
| 8679544 | Apr 23, 2030 | in 3 yr 11 mo | Product |
Diclofenac — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
