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Serving leading biopharmaceutical companies globally:

Julphar
Deloitte
Baxter
QuintilesIMS
Covington
Express Scripts
Queensland Health
Merck
UBS
US Army

Generated: December 16, 2017

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NAFTIN Drug Profile

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When do Naftin patents expire, and what generic alternatives are available?

Naftin is a drug marketed by Sebela Ireland Ltd and is included in three NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has three patent family members in three countries.

The generic ingredient in NAFTIN is naftifine hydrochloride. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the naftifine hydrochloride profile page.

Summary for NAFTIN

Drug patent expirations by year for NAFTIN

Pharmacology for NAFTIN

Ingredient-typeAllylamine
Drug ClassAllylamine Antifungal

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sebela Ireland LtdNAFTINnaftifine hydrochlorideCREAM;TOPICAL019599-001Feb 29, 1988ABRXYesYes► Subscribe► Subscribe► Subscribe
Sebela Ireland LtdNAFTINnaftifine hydrochlorideGEL;TOPICAL204286-001Jun 27, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Sebela Ireland LtdNAFTINnaftifine hydrochlorideCREAM;TOPICAL019599-002Jan 13, 2012ABRXYesYes► Subscribe► Subscribe► Subscribe
Sebela Ireland LtdNAFTINnaftifine hydrochlorideGEL;TOPICAL019356-001Jun 18, 1990RXYesYes► Subscribe► Subscribe► Subscribe
Sebela Ireland LtdNAFTINnaftifine hydrochlorideGEL;TOPICAL204286-001Jun 27, 2013RXYesYes► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: NAFTIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland LtdNAFTINnaftifine hydrochlorideCREAM;TOPICAL019599-001Feb 29, 1988► Subscribe► Subscribe
Sebela Ireland LtdNAFTINnaftifine hydrochlorideGEL;TOPICAL019356-001Jun 18, 1990► Subscribe► Subscribe
Sebela Ireland LtdNAFTINnaftifine hydrochlorideGEL;TOPICAL019356-001Jun 18, 1990► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for NAFTIN

Drugname Dosage Strength RLD Submissiondate
naftifine hydrochlorideGel2%Naftin Gel2/27/2015

Non-Orange Book Patents for Tradename: NAFTIN

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

Country Document Number Estimated Expiration
Canada2899725► Subscribe
World Intellectual Property Organization (WIPO)2014121048► Subscribe
Australia2014212201► 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 leading biopharmaceutical companies globally:

Farmers Insurance
Express Scripts
McKinsey
Accenture
Citi
Cantor Fitzgerald
Covington
QuintilesIMS
US Army
McKesson

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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