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LAMISIL AT

NDA

TERBINAFINE | N021958 | KARO HEALTHCARE INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

3 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 3 - TERBINAFINE tablets, for oral use RE Suitability Petition from... FDA-2023-P-4333 Hyman, Phelps & McNamara, P.C. filed a citizen petition regarding terbinafine tablets for oral use requesting a determination of suitability, likely under FDA mechanisms governing the approvability or regulatory pathway for generic or abbreviated applications for this antifungal medication.	Suitability	2023-10-04	Open	Hyman
Attachment 2 - LAMISIL (terbinafine hydrochloride) tablets, for oral use RE S... FDA-2023-P-4333 Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding LAMISIL (terbinafine hydrochloride) tablets for oral use, requesting a determination of the drug's suitability for ANDA purposes to facilitate the approval of generic versions.	Suitability	2023-10-04	Open	Hyman
Citizen Petition from Unichem Pharmaceuticals (USA), Inc. FDA-2018-P-4549 Unichem Pharmaceuticals (USA), Inc. filed this petition on November 28, 2018, requesting that the FDA designate an additional reference standard for Terbinafine Tablets 250 mg in the Orange Book because the current reference listed drug, LAMISIL (Novartis), is unavailable in the market and preventin	505(q)	2018-11-29	Denied	Unichem Pharmaceuticals (USA)

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs2 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

ALIVUS LIFE SCIENCES LTDTERBINAFINE HYDROCHLORIDE, USP

DMF 181752005

NOVARTIS PHARMACEUTICALS CORPTERBINAFINE

DMF 270592013

OLON SPATERBINAFINE

DMF 330582019

FIS FABBRICA ITALIANA SINTETICI SPAInactiveTERBINAFINE HCL

DMF 202662007

PHARMAZELL DENMARK ASInactiveTERBINAFINE AS TERBINAFINE HYDROCHLORIDE

DMF 241122010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLD

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Jul 24, 2006

No patent or exclusivity listings for this strength.