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Generated: April 24, 2017

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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 freedom to operate?

is the generic ingredient in fourteen branded drugs marketed by Iroko Pharms Llc, Inst Biochem, Depomed Inc, Teva, Sandoz, Novartis, Bionpharma Inc, Watson Labs, Apotex, Mylan, Par Form, Sun Pharm Inds, Apotex Inc, Glenmark Pharms Ltd, Dexcel Ltd, Fougera Pharms, Falcon Pharms, Actavis Elizabeth, Amneal Pharms, Taro, Glaxosmithkline Cons, Horizon Pharma, Sandoz Inc, Lupin Ltd, Pliva, Tolmar, Akorn, Nuvo Res Inc, Watson Labs Inc, Rising Pharms Inc, Teva Pharms, Unique Pharm Labs, Teligent Pharma Inc, 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 sixty-four NDAs. There are forty-three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Diclofenac has thirty-three patent family members in twenty countries.

There are forty-seven drug master file entries for diclofenac. One supplier is listed for this compound. There are five tentative approvals for this compound.

Summary for Generic Name: diclofenac

Drug Master File Entries: see list47
Suppliers / Packagers: see list1
Bulk Api Vendors: see list62
Clinical Trials: see list85
Patent Applications: see list33,952
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:diclofenac at DailyMed

Pharmacology for Ingredient: diclofenac

Tentative approvals for DICLOFENAC

Applicant Application No. Form Dosage
► Subscribe► SubscribeSOLUTION;TOPICAL2%
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL200158-001May 9, 2013ABRXNoNo► Subscribe► Subscribe
Nostrum Labs
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL074986-001Feb 26, 1999DISCNNoNo► Subscribe► Subscribe
Amneal Pharms
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL203995-001Nov 25, 2016ABRXNoNo► Subscribe► Subscribe
diclofenac sodium
GEL;TOPICAL206298-001Apr 28, 2016ABRXNoNo► Subscribe► Subscribe
diclofenac potassium
TABLET;ORAL020142-001Nov 24, 1993DISCNYesNo► Subscribe► Subscribe
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