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Serving leading biopharmaceutical companies globally:

McKinsey
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US Army
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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

Tradename:1
Applicant:1
Ingredient:1
Patents:7
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 Use:INDICATED FOR MANAGEMENT OF OSTEOARTHRITIS PAIN.
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:

Teva
Harvard Business School
Covington
Daiichi Sankyo
Boehringer Ingelheim
US Army
Chubb
Cerilliant
Colorcon
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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