.

BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Drug patents in 130+ countries

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

Serving leading biopharmaceutical companies globally:

UBS
Chinese Patent Office
Fuji
Dow
Harvard Business School
McKesson
Cipla
Argus Health
Queensland Health
Deloitte

Generated: December 13, 2017

DrugPatentWatch Database Preview

DICLOFENAC SODIUM - Generic Drug Details

« Back to Dashboard

What are the generic 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 Actavis Mid Atlantic, Amneal Pharms, Glenmark Pharms Ltd, Taro, Tolmar, Fougera Pharms, Glaxosmithkline Cons, Akorn, Altaire Pharms Inc, Apotex Inc, Bausch And Lomb, Falcon Pharms, Rising Pharms Inc, Sandoz Inc, Novartis, Javelin Pharms Inc, Anda Repository, Lupin Ltd, Novel Labs Inc, Riconpharma Llc, Teligent Pharma Inc, Watson Labs Inc, Horizon Pharma, Nuvo Pharms Inc, Actavis Elizabeth, Allied Pharma Inc, Carlsbad, Mylan Pharms Inc, Pliva, Roxane, Sandoz, Teva, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Mylan, Vpna, Gd Searle Llc, Actavis Labs Fl Inc, and Exela Holdings, and is included in fifty-one 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 forty patent family members in fifteen countries.

There are forty-seven drug master file entries for diclofenac sodium. Eighty-nine suppliers are listed for this compound. There are four tentative approvals for this compound.

Tentative approvals for DICLOFENAC SODIUM

Applicant Application No. Strength Dosage Form
u► Subscribe2%SOLUTION;TOPICAL
u► Subscribe2%SOLUTION;TOPICAL
u► Subscribe2%SOLUTION;TOPICAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Amneal PharmsDICLOFENAC SODIUMdiclofenac sodiumSOLUTION;TOPICAL206116-001Sep 2, 2016ATRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Nuvo Pharms IncPENNSAIDdiclofenac sodiumSOLUTION;TOPICAL020947-001Nov 4, 2009DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
SandozDICLOFENAC SODIUMdiclofenac sodiumTABLET, DELAYED RELEASE;ORAL074376-002Sep 28, 1995ABRXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Horizon PharmaPENNSAIDdiclofenac sodiumSOLUTION;TOPICAL204623-001Jan 16, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Horizon PharmaPENNSAIDdiclofenac sodiumSOLUTION;TOPICAL204623-001Jan 16, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Horizon PharmaPENNSAIDdiclofenac sodiumSOLUTION;TOPICAL204623-001Jan 16, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Horizon PharmaPENNSAIDdiclofenac sodiumSOLUTION;TOPICAL204623-001Jan 16, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
CarlsbadDICLOFENAC SODIUMdiclofenac sodiumTABLET, DELAYED RELEASE;ORAL075185-001Nov 13, 1998ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Glaxosmithkline ConsVOLTARENdiclofenac sodiumGEL;TOPICAL022122-001Oct 17, 2007ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Horizon PharmaPENNSAIDdiclofenac sodiumSOLUTION;TOPICAL204623-001Jan 16, 2014RXYesYes► Subscribe► 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 PharmsDICLOFENAC SODIUMdiclofenac sodiumSOLUTION/DROPS;OPHTHALMIC020809-001May 4, 1998► Subscribe► Subscribe
NovartisVOLTARENdiclofenac sodiumTABLET, DELAYED RELEASE;ORAL019201-001Jul 28, 1988► Subscribe► Subscribe
Fougera PharmsSOLARAZEdiclofenac sodiumGEL;TOPICAL021005-001Oct 16, 2000► Subscribe► Subscribe
Falcon PharmsDICLOFENAC SODIUMdiclofenac sodiumSOLUTION/DROPS;OPHTHALMIC020809-001May 4, 1998► Subscribe► Subscribe
NovartisVOLTARENdiclofenac sodiumTABLET, DELAYED RELEASE;ORAL019201-002Jul 28, 1988► Subscribe► Subscribe
NovartisVOLTARENdiclofenac sodiumSOLUTION/DROPS;OPHTHALMIC020037-001Mar 28, 1991► Subscribe► Subscribe
Fougera PharmsSOLARAZEdiclofenac sodiumGEL;TOPICAL021005-001Oct 16, 2000► Subscribe► Subscribe
Fougera PharmsSOLARAZEdiclofenac sodiumGEL;TOPICAL021005-001Oct 16, 2000► Subscribe► Subscribe
NovartisVOLTARENdiclofenac sodiumSOLUTION/DROPS;OPHTHALMIC020037-001Mar 28, 1991► Subscribe► Subscribe
Fougera PharmsSOLARAZEdiclofenac sodiumGEL;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
New Zealand577020► Subscribe
China101588791► Subscribe
South Korea20080112285► Subscribe
Canada2666398► Subscribe
Australia2007230716► Subscribe
European Patent Office2522344► Subscribe
European Patent Office2626063► Subscribe
Israel194185► Subscribe
South Korea20150050595► Subscribe
Hong Kong1134024► 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 plans and pricing

Serving leading biopharmaceutical companies globally:

Covington
Queensland Health
Argus Health
Medtronic
QuintilesIMS
Julphar
Colorcon
AstraZeneca
Teva
Chubb

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
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot