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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chinese Patent Office
US Army
Express Scripts
Queensland Health

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204592

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NDA 204592 describes ZORVOLEX, which is a drug marketed by Iroko Pharms Llc 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

Formulation / Manufacturing:see details

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 Iroko Pharmaceuticals LLC 42211-203 42211-203-23 30 CAPSULE in 1 BOTTLE (42211-203-23)
ZORVOLEX diclofenac CAPSULE;ORAL 204592 NDA Iroko Pharmaceuticals LLC 42211-203 42211-203-43 1 BLISTER PACK in 1 CARTON (42211-203-43) > 3 CAPSULE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength18MG
Approval Date:Oct 18, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 22, 2017
Regulatory Exclusivity Expiration:Oct 18, 2016
Regulatory Exclusivity Use:NEW PRODUCT
Patent:► SubscribePatent Expiration:Apr 23, 2030Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Daiichi Sankyo
Boehringer Ingelheim
US Army

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