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Diclofenac sodium - Generic Drug Details

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

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

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

Summary for Generic Name: diclofenac sodium

Tradenames:8
Patents:18
Applicants:38
NDAs:47
Drug Master File Entries: see list46
Suppliers / Packaging: see list75
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Tentative approvals for DICLOFENAC SODIUM

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

Clinical Trials for: diclofenac sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teligent Pharma Inc
DICLOFENAC SODIUM
diclofenac sodium
SOLUTION;TOPICAL202769-001Jul 8, 2015RXNo<disabled><disabled>
Tolmar
DICLOFENAC SODIUM
diclofenac sodium
GEL;TOPICAL200936-001Oct 28, 2013RXNo<disabled><disabled>
Teva
DICLOFENAC SODIUM
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL074390-001Aug 15, 1996DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: diclofenac sodium

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,929,048<disabled>
Novartis
VOLTAREN
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC020037-001Mar 28, 19914,960,799<disabled>
Falcon Pharms
DICLOFENAC SODIUM
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC020809-001May 4, 19985,603,929<disabled>
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Non-Orange Book Patents for Generic Ingredient: diclofenac sodium

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,852,002 Treatment of conditions and disease<disabled in preview>
5,834,444 Hyaluronic acid and salts thereof inhibit arterial restenosis<disabled in preview>
6,147,059 Formulations containing hyaluronic acid<disabled in preview>
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International Patent Family for Ingredient: diclofenac sodium

Country Document Number Estimated Expiration
Russian Federation2009118392<disabled in preview>
Australia3159595<disabled in preview>
World Intellectual Property Organization (WIPO)9530423<disabled in preview>
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