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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, Glaxosmithkline Cons, Akorn, Alcon Pharms Ltd, Apotex Inc, Bausch And Lomb, Falcon Pharms, Nexus Pharms, Novartis, Javelin Pharms Inc, Igi Labs Inc, Lupin Ltd, 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-two 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 is one tentative approval for this compound.

Summary for Generic Name: diclofenac sodium

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

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
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
Teva Pharms
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL074459-002Jun 25, 1997DISCNNo<disabled><disabled>
Unique Pharm Labs
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL090066-002Dec 1, 2010RXNo<disabled><disabled>
Alcon Pharms Ltd
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC078031-001Feb 6, 2008RXNo<disabled><disabled>
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International Patent Family for Ingredient: diclofenac sodium

Country Document Number Publication Date
South Korea20150050595May 08, 2015
Australia7022496Dec 19, 1996
European Patent Office0758246Feb 19, 1997
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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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