Details for New Drug Application (NDA): 204592
✉ Email this page to a colleague
The generic ingredient in ZORVOLEX is diclofenac. There are forty-seven drug master file entries for this compound. Additional details are available on the diclofenac profile page.
Summary for 204592
Tradename: | ZORVOLEX |
Applicant: | Zyla |
Ingredient: | diclofenac |
Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 204592
Generic Entry Date for 204592*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Medical Subject Heading (MeSH) Categories for 204592
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Oct 18, 2013 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 23, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 23, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF PAIN | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 23, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? |
Complete Access Available with Subscription