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Serving leading biopharmaceutical companies globally:

Moodys
US Army
Express Scripts
Citi
Chubb
Fuji
Harvard Business School
Covington
Medtronic
US Department of Justice

Generated: January 20, 2018

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Diclofenac - Generic Drug Details

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What are the generic sources for diclofenac and what is the scope of diclofenac freedom to operate?

Diclofenac
is the generic ingredient in fourteen branded drugs marketed by Iroko Pharms Llc, Inst Biochem, Bionpharma Inc, Depomed Inc, Par Form, Novartis, Apotex, Mylan, Sandoz, Sun Pharm Industries, Teva, Watson Labs Teva, Actavis Mid Atlantic, Amneal Pharms, Glenmark Pharms Ltd, Taro, Tolmar, Fougera Pharms, Glaxosmithkline Cons, Akorn, Altaire Pharms Inc, Apotex Inc, Bausch And Lomb, Falcon Pharms, Rising Pharms Inc, Sandoz Inc, Javelin Pharms Inc, Anda Repository, Lupin Ltd, Novel Labs Inc, Riconpharma Llc, Teligent Pharma Inc, Watson Labs Inc, Horizon Pharma, Nuvo Pharms Inc, Actavis Elizabeth, Allied Pharma Inc, Carlsbad, Mylan Pharms Inc, Pliva, Roxane, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Vpna, Gd Searle Llc, Actavis Labs Fl Inc, and Exela Holdings, and is included in sixty-five NDAs. There are forty-two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Diclofenac has forty patent family members in twenty-two countries.

There are forty-seven drug master file entries for diclofenac. One supplier is listed for this compound. There are four tentative approvals for this compound.
Summary for diclofenac
Pharmacology for diclofenac
Medical Subject Heading (MeSH) Categories for diclofenac
Tentative approvals for DICLOFENAC
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe2%SOLUTION;TOPICAL
➤ Subscribe➤ Subscribe2%SOLUTION;TOPICAL
➤ Subscribe➤ Subscribe2%SOLUTION;TOPICAL

US Patents and Regulatory Information for diclofenac

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nuvo Pharms Inc PENNSAID diclofenac sodium SOLUTION;TOPICAL 020947-001 Nov 4, 2009 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Roxane DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074391-003 Jun 29, 1995 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 075281-002 Feb 12, 2002 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Actavis Elizabeth DICLOFENAC SODIUM diclofenac sodium TABLET, EXTENDED RELEASE;ORAL 075910-001 Jan 7, 2002 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Form DICLOFENAC POTASSIUM diclofenac potassium FOR SOLUTION;ORAL 202964-001 May 2, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Horizon Pharma PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sun Pharm Industries DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075470-001 Feb 21, 2002 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074723-001 Mar 30, 1999 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Iroko Pharms Llc ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 RX Yes Yes ➤ 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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Non-Orange Book US Patents for diclofenac

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 diclofenac

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Serving leading biopharmaceutical companies globally:

Covington
US Army
Accenture
Farmers Insurance
AstraZeneca
Cantor Fitzgerald
Chinese Patent Office
Merck
Queensland Health

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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