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Diclofenac sodium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for diclofenac sodium?

Diclofenac sodium is the generic ingredient in eight branded drugs marketed by Apotex Inc, Glenmark Pharms Ltd, Novartis, Dexcel Ltd, Fougera Pharms, Falcon Pharms, Actavis Elizabeth, Amneal Pharms, Taro, Glaxosmithkline Cons, Horizon Pharma, Teva, Sandoz Inc, Lupin Ltd, Pliva, Tolmar, Akorn, Nuvo Res Inc, Watson Labs Inc, Mylan, Rising Pharms Inc, Teva Pharms, Unique Pharm Labs, Teligent Pharma Inc, Sandoz, Novel Labs Inc, Mylan Pharms Inc, Altaire Pharms Inc, Carlsbad, Nostrum Labs, Roxane, Bausch And Lomb, Vpna, Actavis Mid Atlantic, Paddock Llc, Javelin Pharms Inc, Gd Searle Llc, Eagle Pharms, and Actavis Labs Fl Inc, and is included in fifty NDAs. There are twenty-one patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-eight patent family members in fifteen countries.

There are forty-seven drug master file entries for diclofenac sodium. Eighty-one suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for Generic Name: diclofenac sodium

Tradenames:8
Patents:22
Applicants:39
NDAs:50
Drug Master File Entries: see list47
Suppliers / Packagers: see list81
Bulk Api Vendors: see list68
Clinical Trials: see list981
Patent Applications: see list6,198
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:diclofenac sodium at DailyMed

Tentative approvals for DICLOFENAC SODIUM

Applicant Application No. Form Dosage
► Subscribe► SubscribeSOLUTION;TOPICAL2%
► Subscribe► SubscribeSOLUTION;TOPICAL2%
► Subscribe► SubscribeSOLUTION;TOPICAL2%
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nuvo Res Inc
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL020947-001Nov 4, 2009DISCNYesNo8,217,078► Subscribe ► Subscribe
Horizon Pharma
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014RXYesYes8,563,613► SubscribeY ► Subscribe
Unique Pharm Labs
DICLOFENAC SODIUM
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL090066-001Dec 1, 2010RXNoNo► Subscribe► Subscribe
Nuvo Res Inc
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL020947-001Nov 4, 2009DISCNYesNo8,618,164► Subscribe ► Subscribe
Actavis Labs Fl Inc
DICLOFENAC SODIUM AND MISOPROSTOL
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL201089-002Jul 9, 2012RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: diclofenac sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
VOLTAREN
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC020037-001Mar 28, 19914,829,088► Subscribe
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,639,738► Subscribe
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,929,048► Subscribe
Novartis
VOLTAREN
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL019201-003Jul 28, 19883,652,762► Subscribe
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,985,850► Subscribe
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Non-Orange Book Patents for Generic Ingredient: diclofenac sodium

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
8,580,954Formulations of low dose diclofenac and beta-cyclodextrin► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: diclofenac sodium

Country Document Number Estimated Expiration
Russian Federation2463038► Subscribe
South Africa200808115► Subscribe
South Korea20160033796► Subscribe
Japan5432716► Subscribe
China104606126► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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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