Generic Naftin Availability
Last updated on Mar 13, 2025.
Naftin is a brand name of naftifine topical, approved by the FDA in the following formulation(s):
NAFTIN (naftifine hydrochloride - cream;topical)
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Manufacturer: LEGACY PHARMA
Approval date: February 29, 1988
Strength(s): 1% (discontinued) [RLD] -
Manufacturer: LEGACY PHARMA
Approval date: January 13, 2012
Strength(s): 2% [RLD] [AB]
NAFTIN (naftifine hydrochloride - gel;topical)
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Manufacturer: LEGACY PHARMA
Approval date: June 18, 1990
Strength(s): 1% [RLD] [AB] -
Manufacturer: LEGACY PHARMA
Approval date: June 27, 2013
Strength(s): 2% [RLD] [AB]
Has a generic version of Naftin been approved?
A generic version of Naftin has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Naftin and have been approved by the FDA:
naftifine hydrochloride cream;topical
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Manufacturer: AMNEAL
Approval date: April 10, 2017
Strength(s): 2% [AB] -
Manufacturer: TARO
Approval date: January 6, 2016
Strength(s): 2% [AB] -
Manufacturer: XIROMED
Approval date: September 22, 2020
Strength(s): 2% [AB]
naftifine hydrochloride gel;topical
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Manufacturer: AMNEAL
Approval date: March 20, 2019
Strength(s): 1% [AB] -
Manufacturer: TARO
Approval date: April 10, 2019
Strength(s): 2% [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Naftin. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Topical compositions and methods for making and using same
Patent 10,166,205
Issued: January 1, 2019
Inventor(s): Hardas Bhushan & Dalton Donna
Assignee(s): SEBELA INTERNATIONAL BERMUDA LIMITEDA gel composition for topical administration that includes: naftifine or a pharmaceutically acceptable salt thereof; a solvent; a non-carbomer rheology modifier; a polysorbate solubilizing agent; and an amine pH adjuster.
Patent expiration dates:
- January 31, 2033✓
- January 31, 2033
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Topical compositions and methods for making and using same
Patent 10,166,206
Issued: January 1, 2019
Inventor(s): Hardas Bhushan & Dalton Donna & Scheppler Petra & Buch Anja & Boderke Peter
Assignee(s): SEBELA INTERNATIONAL BERMUDA LIMITEDThe present invention relates to improved topical gel compositions comprising an active agent, and uses thereof.
Patent expiration dates:
- January 31, 2033✓
- January 31, 2033
-
Topical compositions and methods for making and using same
Patent 10,695,303
Issued: June 30, 2020
Inventor(s): Hardas Bhushan & Dalton Donna
Assignee(s): Sebela Ireland LimitedThe present invention relates to improved topical gel compositions comprising an active agent, and uses thereof.
Patent expiration dates:
- January 31, 2033✓
- January 31, 2033
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Topical compositions and methods for making and using same
Patent 10,729,667
Issued: August 4, 2020
Inventor(s): Hardas Bhushan & Dalton Donna & Scheppler Petra & Buch Anja & Boderke PeterThe present invention relates to improved topical gel compositions comprising an active agent, and uses thereof.
Patent expiration dates:
- January 31, 2033✓
- January 31, 2033
-
Topical compositions and methods for making and using same
Patent 8,778,365
Issued: July 15, 2014
Inventor(s): Hardas Bhushan & Dalton Donna
Assignee(s): Merz Pharmaceuticals, LLCThe present invention relates to improved topical gel compositions comprising an active agent, and uses thereof.
Patent expiration dates:
- January 31, 2033✓
- January 31, 2033
-
Topical compositions and methods for making and using same
Patent 9,161,914
Issued: October 20, 2015
Inventor(s): Hardas Bhushan & Dalton Donna
Assignee(s): Merz Pharmaceuticals, LLCThe present invention relates to improved topical gel compositions comprising an active agent, and uses thereof.
Patent expiration dates:
- January 31, 2033✓
- January 31, 2033
More about Naftin (naftifine topical)
- Compare alternatives
- Pricing & coupons
- Reviews (2)
- Side effects
- Dosage information
- During pregnancy
- Drug class: topical antifungals
- Breastfeeding
- En español
Patient resources
Professional resources
Other formulations
Related treatment guides
Glossary
Term | Definition |
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Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.