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US Army
AstraZeneca
QuintilesIMS
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Generated: August 23, 2017

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Diclofenac - Generic Drug Details

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What are the generic sources for diclofenac and what is the scope of diclofenac freedom to operate?

Diclofenac
is the generic ingredient in fourteen branded drugs marketed by Iroko Pharms Llc, Inst Biochem, Depomed Inc, Teva, Sandoz, Novartis, Bionpharma Inc, Watson Labs Teva, Apotex, Mylan, Par Form, Sun Pharm Inds, Apotex Inc, Glenmark Pharms Ltd, Dexcel Ltd, Fougera Pharms, Falcon Pharms, Actavis Elizabeth, Amneal Pharms, Taro, Glaxosmithkline Cons, Horizon Pharma, Sandoz Inc, Lupin Ltd, Pliva, Tolmar, Actavis Labs Ut Inc, Akorn, Nuvo Pharms Inc, Watson Labs Inc, Rising Pharms Inc, Teva Pharms, Unique Pharm Labs, Teligent Pharma Inc, 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 sixty-five NDAs. There are forty-two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Diclofenac has thirty-seven patent family members in twenty countries.

There are forty-seven drug master file entries for diclofenac. One supplier is listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: diclofenac

Tradenames:14
Patents:42
Applicants:48
NDAs:65
Drug Master File Entries: see list47
Suppliers / Packagers: see list1
Bulk Api Vendors: see list62
Clinical Trials: see list282
Patent Applications: see list33,952
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:diclofenac at DailyMed

Pharmacology for Ingredient: diclofenac

Tentative approvals for DICLOFENAC

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
Horizon Pharma
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014ATRXYesYes► Subscribe► Subscribe ► Subscribe
Javelin Pharms Inc
DYLOJECT
diclofenac sodium
SOLUTION;INTRAVENOUS022396-001Dec 23, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 2000ABRXYesYes► Subscribe► Subscribe► Subscribe
Novartis
VOLTAREN
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL019201-003Jul 28, 1988DISCNYesNo► Subscribe► Subscribe► Subscribe
Horizon Pharma
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014ATRXYesYes► Subscribe► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: diclofenac

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
8,735,450Formulation of diclofenac► Subscribe
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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.

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International Patent Family for Ingredient: diclofenac

Country Document Number Estimated Expiration
New Zealand620887► Subscribe
China106727424► Subscribe
New Zealand595987► Subscribe
Japan2015157851► Subscribe
Mexico337619► Subscribe
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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.

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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Citi
Argus Health
Baxter
Healthtrust
Moodys
Cipla
QuintilesIMS
Mallinckrodt
US Army

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.

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