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Diclofenac - Generic Drug Details

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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, 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, Alcon Pharms Ltd, Lupin Ltd, Pliva, Tolmar, Akorn, Nuvo Res 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, Nostrum Labs, Roxane, Bausch And Lomb, Vpna, Actavis Mid Atlantic, Paddock Llc, Javelin Pharms Inc, Gd Searle Llc, Eagle Pharms, and Actavis Labs Fl Inc, and is included in sixty-four NDAs. There are forty-one patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-nine patent family members in nineteen countries.

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

Summary for Generic Name: diclofenac

Tradenames:14
Patents:41
Applicants:47
NDAs:64
Drug Master File Entries: see list47
Suppliers / Packagers: see list1
Bulk Api Vendors: see list62
Clinical Trials: see list85
Patent Applications: see list20,278
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. Form Dosage
<disabled><disabled>SOLUTION;TOPICAL2%
<disabled><disabled>SOLUTION;TOPICAL2%
<disabled><disabled>SOLUTION;TOPICAL2%
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon Pharma
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014RXYesYes8,546,450► subscribe ► subscribe
Iroko Pharms Llc
ZORVOLEX
diclofenac
CAPSULE;ORAL204592-002Oct 18, 2013RXYesYes9,180,096► subscribeY ► subscribe
Mylan Pharms Inc
DICLOFENAC SODIUM
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL075281-002Feb 12, 2002RXNoNo► 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
Israel215869► subscribe
Colombia6470810► subscribe
South Korea20140124873► 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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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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