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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 Tolmar, Fougera Pharms, Novartis, Akorn, Alcon Pharms Ltd, Apotex Inc, Bausch And Lomb, Falcon Pharms, Nexus Pharms, Javelin Pharms 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, Valeant Intl, Gd Searle Llc, Actavis Labs Fl Inc, and Eagle Pharms, and is included in forty NDAs. There are fourteen 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 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 is one tentative approval for this compound.

Summary for Generic Name: diclofenac sodium

Drug Master File Entries: see list46
Suppliers: see list24
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Tentative approvals for DICLOFENAC SODIUM

Applicant Application No. Form Dosage

Clinical Trials for: diclofenac sodium

Pharmacokinetics, Bioavailability and Safety of PENNSAID® Gel
Status: Completed Condition: Pain

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

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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
Falcon Pharms
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC020809-001May 4, 1998DISCNNo5,603,929<disabled><disabled>
Nuvo Res Inc
diclofenac sodium
SOLUTION;TOPICAL020947-001Nov 4, 2009RXYes8,546,450<disabled><disabled>
Horizon Pharma
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014RXYes8,741,956<disabled><disabled>
Unique Pharm Labs
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL090066-001Dec 1, 2010RXNo<disabled><disabled>
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL019201-001Jul 28, 1988DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: diclofenac sodium

Country Document Number Publication Date
China1130532Sep 11, 1996
Australia3159595Mar 22, 1996
South Korea20080112285Dec 24, 2008
Greece3021171Dec 31, 1996
Hungary211698Dec 28, 1995
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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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