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FDA Orange Book · active-ingredient family

Naftifine hydrochloride

Naftifine hydrochloride is approved as 3 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:NAFTIN · NDA 204286

3

Brand (NDA)

6

Generics (ANDA)

6

Listed patents

0

Exclusivity periods

Brand (NDA) products · cream, gel

ProductApplicantApplicationTEApproved
NAFTINRLDLEGACY PHARMANDA 204286ABJun 27, 2013
NAFTINRLDLEGACY PHARMANDA 019356—Jun 18, 1990
NAFTINRLD×2LEGACY PHARMANDA 019599—Feb 29, 1988

Generic (ANDA) products (6)

ProductApplicantApplicationTEApproved
NAFTIFINE HYDROCHLORIDEXIROMEDANDA 210038ABSep 22, 2020
NAFTIFINE HYDROCHLORIDESUN PHARMA CANADAANDA 208201ABApr 10, 2019
NAFTIFINE HYDROCHLORIDEAMNEALANDA 206165—Mar 20, 2019
NAFTIFINE HYDROCHLORIDEAMNEALANDA 206960—Apr 10, 2017
NAFTIFINE HYDROCHLORIDESUN PHARMA CANADAANDA 205975—Sep 08, 2016
NAFTIFINE HYDROCHLORIDESUN PHARMA CANADAANDA 206901ABJan 06, 2016

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9161914Jan 31, 2033in 6 yr 9 mo
U-540
10729667Jan 31, 2033in 6 yr 9 mo
Product
8778365Jan 31, 2033in 6 yr 9 mo
Product
10695303Jan 31, 2033in 6 yr 9 mo
Product
10166206Jan 31, 2033in 6 yr 9 mo
Product
10166205Jan 31, 2033in 6 yr 9 mo
Product

Naftifine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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