Naftifine hydrochloride - Generic Drug Details

✉ Email this page to a colleague

What are the generic sources for naftifine hydrochloride and what is the scope of patent protection?

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

Naftifine hydrochloride has three patent family members in three countries.

There are seven drug master file entries for naftifine hydrochloride. Three suppliers are listed for this compound.

Summary for naftifine hydrochloride

International Patents:	3
US Patents:	6
Tradenames:	2
Applicants:	4
NDAs:	9
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	9
Patent Applications:	908
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for naftifine hydrochloride
What excipients (inactive ingredients) are in naftifine hydrochloride?	naftifine hydrochloride excipients list
DailyMed Link:	naftifine hydrochloride at DailyMed

Recent Clinical Trials for naftifine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Semler Research Center Pvt. Ltd.	Phase 3
Genzum Life Sciences	Phase 3
GenZum Life Sciences LLC	Phase 3

See all naftifine hydrochloride clinical trials

Pharmacology for naftifine hydrochloride

Drug Class	Allylamine Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for naftifine hydrochloride

D01AE	Other antifungals for topical use
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

Paragraph IV (Patent) Challenges for NAFTIFINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAFTIN	Gel	naftifine hydrochloride	2%	204286	1	2015-02-04

US Patents and Regulatory Information for naftifine hydrochloride

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286-001	Jun 27, 2013	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286-001	Jun 27, 2013	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Taro	NAFTIFINE HYDROCHLORIDE	naftifine hydrochloride	CREAM;TOPICAL	206901-001	Jan 6, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for naftifine hydrochloride

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	CREAM;TOPICAL	019599-001	Feb 29, 1988	⤷ Sign Up	⤷ Sign Up
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990	⤷ Sign Up	⤷ Sign Up
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for naftifine hydrochloride

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2014121048		⤷ Sign Up
Australia	2014212201		⤷ Sign Up
Canada	2899725	COMPOSITIONS TOPIQUES ET PROCEDES DE PREPARATION ET D'UTILISATION CORRESPONDANTS (TOPICAL COMPOSITIONS AND METHODS FOR MAKING AND USING SAME)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.