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Naftifine hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for naftifine hydrochloride?

Naftifine hydrochloride is the generic ingredient in two branded drugs marketed by Taro and Sebela Ireland Ltd, and is included in five NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has three patent family members in three countries.

There are eight drug master file entries for naftifine hydrochloride. Four suppliers are listed for this compound.

Summary for Generic Name: naftifine hydrochloride

Tradenames:2
Patents:3
Applicants:2
NDAs:5
Drug Master File Entries: see list8
Suppliers / Packagers: see list4
Bulk Api Vendors: see list44
Clinical Trials: see list989
Patent Applications: see list292
Therapeutic Class:Antifungals
Drug Prices:see low prices
DailyMed Link:naftifine hydrochloride at DailyMed

Pharmacology for Ingredient: naftifine hydrochloride

Ingredient-typeAllylamine
Drug ClassAllylamine Antifungal
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro
NAFTIFINE HYDROCHLORIDE
naftifine hydrochloride
CREAM;TOPICAL206901-001Jan 6, 2016RXNoNo► Subscribe► Subscribe
Sebela Ireland Ltd
NAFTIN
naftifine hydrochloride
GEL;TOPICAL204286-001Jun 27, 2013RXYesYes9,161,914► Subscribe ► Subscribe
Sebela Ireland Ltd
NAFTIN
naftifine hydrochloride
CREAM;TOPICAL019599-001Feb 29, 1988RXYesYes► Subscribe► Subscribe
Sebela Ireland Ltd
NAFTIN
naftifine hydrochloride
GEL;TOPICAL204286-001Jun 27, 2013RXYesYes8,778,365► SubscribeY ► Subscribe
Sebela Ireland Ltd
NAFTIN
naftifine hydrochloride
GEL;TOPICAL019356-001Jun 18, 1990RXYesYes► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: naftifine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd
NAFTIN
naftifine hydrochloride
GEL;TOPICAL019356-001Jun 18, 19904,282,251► Subscribe
Sebela Ireland Ltd
NAFTIN
naftifine hydrochloride
GEL;TOPICAL019356-001Jun 18, 19904,828,251► Subscribe
Sebela Ireland Ltd
NAFTIN
naftifine hydrochloride
CREAM;TOPICAL019599-001Feb 29, 19884,282,251► Subscribe
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Non-Orange Book Patents for Generic Ingredient: naftifine hydrochloride

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
9,452,173Topical compositions and methods for making and using same► Subscribe
9,446,131Topical compositions and methods for making and using same► Subscribe
9,433,680Topical compositions and methods for making and using same► 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: naftifine hydrochloride

Country Document Number Estimated Expiration
Australia2014212201► Subscribe
Canada2899725► Subscribe
World Intellectual Property Organization (WIPO)2014121048► 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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