.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

► See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

McKesson
Accenture
Johnson and Johnson
Daiichi Sankyo
QuintilesIMS
Citi
Fish and Richardson
Argus Health
Chubb
Cipla

Generated: September 24, 2017

DrugPatentWatch Database Preview

Diclofenac sodium - Generic Drug Details

« Back to Dashboard

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, Riconpharma Llc, Amneal Pharms, Taro, Glaxosmithkline Cons, Horizon Pharma, Teva, Sandoz Inc, Lupin Ltd, Pliva, Tolmar, Actavis Labs Ut Inc, 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-two NDAs. There are twenty-one patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diclofenac sodium has thirty-nine 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:21
Applicants:41
NDAs:52
Drug Master File Entries: see list47
Suppliers / Packagers: see list83
Bulk Api Vendors: see list75
Clinical Trials: see list2,565
Patent Applications: see list6,470
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
Carlsbad
DICLOFENAC SODIUM
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL075185-001Nov 13, 1998ABRXNoNo► Subscribe► Subscribe► Subscribe
Horizon Pharma
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014ATRXYesYes► Subscribe► Subscribe► Subscribe
Sandoz
DICLOFENAC SODIUM AND MISOPROSTOL
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL200158-002May 9, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Actavis Elizabeth
DICLOFENAC SODIUM
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL074514-001Mar 26, 1996ABRXNoNo► Subscribe► Subscribe► Subscribe
Unique Pharm Labs
DICLOFENAC SODIUM
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL090066-001Dec 1, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Rising Pharms Inc
DICLOFENAC SODIUM
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC078553-001Dec 28, 2007ATRXNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms
DICLOFENAC SODIUM AND MISOPROSTOL
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL203995-001Nov 25, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Horizon Pharma
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014ATRXYesYes► Subscribe► Subscribe ► Subscribe
Tolmar
DICLOFENAC SODIUM
diclofenac sodium
GEL;TOPICAL200936-001Oct 28, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
DICLOFENAC SODIUM
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL074459-003Jun 25, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: diclofenac sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Falcon Pharms
DICLOFENAC SODIUM
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC020809-001May 4, 1998► Subscribe► Subscribe
Novartis
VOLTAREN
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC020037-001Mar 28, 1991► Subscribe► Subscribe
Novartis
VOLTAREN
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL019201-001Jul 28, 1988► Subscribe► Subscribe
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 2000► Subscribe► Subscribe
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 2000► Subscribe► Subscribe
Novartis
VOLTAREN
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC020037-001Mar 28, 1991► Subscribe► Subscribe
Novartis
VOLTAREN
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL019201-003Jul 28, 1988► Subscribe► Subscribe
Falcon Pharms
DICLOFENAC SODIUM
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC020809-001May 4, 1998► Subscribe► Subscribe
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 2000► Subscribe► Subscribe
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 2000► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
8,580,954Formulations of low dose diclofenac and beta-cyclodextrin► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: diclofenac sodium

Country Document Number Estimated Expiration
South Korea20150050595► Subscribe
European Patent Office2086504► Subscribe
World Intellectual Property Organization (WIPO)2007112272► Subscribe
China104606126► Subscribe
South Korea20140038575► Subscribe
China101410123► Subscribe
Mexico2008012495► Subscribe
China102846585► Subscribe
Mexico2009004038► Subscribe
South Korea20080112285► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Covington
Baxter
Medtronic
Deloitte
Cantor Fitzgerald
UBS
Merck
Farmers Insurance
Healthtrust
Dow

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot