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Details for Generic Name: diclofenac sodium

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

This ingredient has two hundred and thirty-two patent family members in thirty-three countries.

There are forty-six drug master file entries for diclofenac sodium. Twenty-four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: diclofenac sodium

Tradenames:8
Patents:19
Applicants:37
NDAs:45
Drug Master File Entries: see list46
Suppliers / Packaging: see list56
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents

Tentative approvals for DICLOFENAC SODIUM

Applicant Application No. Form Dosage
<disabled><disabled>SOLUTION;TOPICAL2%
<disabled><disabled>SOLUTION;TOPICAL2%

Clinical Trials for: diclofenac sodium

Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers
Status: Completed Condition: Healthy

A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea
Status: Completed Condition: Primary Dysmenorrhea

Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium
Status: Completed Condition: Pain

A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® Gel 3% in the Treatment of Actinic Keratosis
Status: Completed Condition: Actinic Keratosis

Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer Acetate
Status: Completed Condition: Multiple Sclerosis

Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain
Status: Terminated Condition: Ankle Sprain

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dexcel Ltd
DICLOFENAC SODIUM
diclofenac sodium
TABLET, EXTENDED RELEASE;ORAL076201-001Nov 6, 2002RXNo<disabled><disabled>
Actavis Labs Fl Inc
DICLOFENAC SODIUM AND MISOPROSTOL
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL201089-002Jul 9, 2012RXNo<disabled><disabled>
Sandoz
DICLOFENAC SODIUM AND MISOPROSTOL
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL200158-001May 9, 2013RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: diclofenac sodium

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
VOLTAREN
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC020037-001Mar 28, 19913,652,762<disabled>
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,929,048<disabled>
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,639,738<disabled>
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International Patent Family for Ingredient: diclofenac sodium

Country Document Number Publication Date
JapanH10504828May 12, 1998
Denmark0739197Oct 29, 2001
Mexico9300904Oct 01, 1993
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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