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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Johnson and Johnson
US Army
Medtronic
Cerilliant
Merck
Daiichi Sankyo
US Department of Justice
AstraZeneca

Generated: June 24, 2018

DrugPatentWatch Database Preview

ZORVOLEX Drug Profile

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Which patents cover Zorvolex, and when can generic versions of Zorvolex launch?

Zorvolex is a drug marketed by Iroko Pharms Llc and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has forty-two patent family members in twenty-two countries.

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.

US Patents and Regulatory Information for ZORVOLEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Iroko Pharms Llc ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Iroko Pharms Llc ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Iroko Pharms Llc ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Iroko Pharms Llc ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for ZORVOLEX
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Capsules 18 mg and 35 mg ➤ Subscribe 2014-06-06

Non-Orange Book US Patents for ZORVOLEX

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,735,450 Formulation of diclofenac ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
US Department of Justice
Cipla
Accenture
Queensland Health
Federal Trade Commission
Teva
QuintilesIMS
Julphar

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