Details for New Drug Application (NDA): 204592

NDA 204592 describes ZORVOLEX, which is a drug marketed by Zyla and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ZORVOLEX profile page.

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

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

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

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DISCN	Dosage:	CAPSULE;ORAL			Strength	18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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:		Patent Expiration:	Apr 23, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:		Patent Expiration:	Apr 23, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PAIN
Patent:		Patent Expiration:	Apr 23, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

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