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Generated: May 27, 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 diclofenac sodium 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 Pharms 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, Allied Pharma Inc, 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-three suppliers are listed for this compound. There are four 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 list83
Bulk Api Vendors: see list70
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. Strength Dosage Form
► Subscribe► Subscribe2%SOLUTION;TOPICAL
► Subscribe► Subscribe2%SOLUTION;TOPICAL
► Subscribe► Subscribe2%SOLUTION;TOPICAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon Pharma
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014RXYesYes9,132,110► Subscribe ► Subscribe
Carlsbad
DICLOFENAC SODIUM
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL075185-003Nov 13, 1998ABRXNoNo► Subscribe► Subscribe
Horizon Pharma
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014RXYesYes9,370,501► Subscribe ► Subscribe
Amneal Pharms
DICLOFENAC SODIUM AND MISOPROSTOL
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL203995-002Nov 25, 2016ABRXNoNo► Subscribe► Subscribe
Horizon Pharma
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014RXYesYes9,220,784► Subscribe ► Subscribe
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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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