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Last Updated: January 17, 2021

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Details for New Drug Application (NDA): 204592

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NDA 204592 describes ZORVOLEX, which is a drug marketed by Zyla and is included in one NDA. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the diclofenac profile page.
Summary for 204592
Tradename:ZORVOLEX
Applicant:Zyla
Ingredient:diclofenac
Patents:7
Formulation / Manufacturing:see details
Generic Entry Opportunity 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.

Pharmacology for NDA: 204592
Medical Subject Heading (MeSH) Categories for 204592
Suppliers and Packaging for NDA: 204592
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZORVOLEX diclofenac CAPSULE;ORAL 204592 NDA Zyla Life Sciences US Inc. 69344-203 69344-203-29 90 CAPSULE in 1 BOTTLE (69344-203-29)
ZORVOLEX diclofenac CAPSULE;ORAL 204592 NDA Zyla Life Sciences US Inc. 69344-204 69344-204-29 90 CAPSULE in 1 BOTTLE (69344-204-29)
Paragraph IV (Patent) Challenges for 204592
Tradename Dosage Ingredient NDA Submissiondate
ZORVOLEX CAPSULE;ORAL diclofenac 204592 2014-06-06

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength18MG
Approval Date:Oct 18, 2013TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 23, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Apr 23, 2030Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Apr 23, 2030Product Flag?YSubstance Flag?Delist Request?

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