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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Citi
Dow
Baxter
Queensland Health
Medtronic
Federal Trade Commission
Teva
Chinese Patent Office
Deloitte

Generated: January 16, 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 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.
Summary for ZORVOLEX
Drug patent expirations by year for ZORVOLEX
Medical Subject Heading (MeSH) Categories for ZORVOLEX

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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Iroko Pharms Llc ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Iroko Pharms Llc ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Iroko Pharms Llc ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Iroko Pharms Llc ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Iroko Pharms Llc ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Iroko Pharms Llc ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Iroko Pharms Llc ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Iroko Pharms Llc ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Iroko Pharms Llc ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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 6/6/2014

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 ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for ZORVOLEX

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Serving leading biopharmaceutical companies globally:

Queensland Health
McKinsey
UBS
Federal Trade Commission
McKesson
Farmers Insurance
AstraZeneca
US Army
Cerilliant

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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