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Generated: April 28, 2017

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Diclofenac sodium - Generic Drug Details

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What are the generic drug sources for diclofenac sodium and what is the scope of patent protection?

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, Twi Pharms Inc, Javelin Pharms Inc, Gd Searle Llc, Exela Holdings, and Actavis Labs Fl Inc, and is included in fifty NDAs. There are twenty-two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diclofenac sodium 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

Drug Master File Entries: see list47
Suppliers / Packagers: see list81
Bulk Api Vendors: see list68
Clinical Trials: see list981
Patent Applications: see list6,608
Therapeutic Class: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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms
diclofenac sodium
SOLUTION;TOPICAL206116-001Sep 2, 2016ATRXNoNo► Subscribe► Subscribe
Horizon Pharma
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014RXYesYes9,370,501► Subscribe ► Subscribe
diclofenac sodium
GEL;TOPICAL200936-001Oct 28, 2013ABRXNoNo► Subscribe► Subscribe
Teligent Pharma Inc
diclofenac sodium
SOLUTION;TOPICAL202769-001Jul 8, 2015ATRXNoNo► Subscribe► Subscribe
Unique Pharm Labs
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL090066-001Dec 1, 2010ABRXNoNo► Subscribe► Subscribe
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