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Serving leading biopharmaceutical companies globally:

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Federal Trade Commission
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Fuji
Express Scripts
Covington

Generated: February 21, 2018

DrugPatentWatch Database Preview

TERBINAFINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for terbinafine hydrochloride and what is the scope of terbinafine hydrochloride freedom to operate?

Terbinafine hydrochloride
is the generic ingredient in three branded drugs marketed by Glaxosmithkline, Novartis, Taro, Glaxosmithkline Cons, Apotex, Aurobindo Pharma, Breckenridge Pharm, Cipla Ltd, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Generics, Harris Pharm, Invagen Pharms, Mylan, Orchid Hlthcare, Roxane, Teva, and Wockhardt, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for terbinafine hydrochloride. Fifty-five suppliers are listed for this compound. There are four tentative approvals for this compound.
Pharmacology for TERBINAFINE HYDROCHLORIDE
Ingredient-typeAllylamine
Drug ClassAllylamine Antifungal
Tentative approvals for TERBINAFINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign UpEQ 250MG BASETABLET; ORAL
➤ Sign Up➤ Sign UpEQ 250MG BASETABLET;ORAL
➤ Sign Up➤ Sign UpEQ 250MG BASETABLET;ORAL

US Patents and Regulatory Information for TERBINAFINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Invagen Pharms TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077533-001 Jul 2, 2007 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis LAMISIL terbinafine hydrochloride GRANULE;ORAL 022071-001 Sep 28, 2007 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glenmark Generics TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 078157-001 Jul 2, 2007 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Taro TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride CREAM;TOPICAL 077511-001 Jul 2, 2007 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glaxosmithkline Cons LAMISIL terbinafine hydrochloride SOLUTION;TOPICAL 020749-001 Oct 17, 1997 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis LAMISIL AT terbinafine hydrochloride SOLUTION;TOPICAL 021124-001 Mar 17, 2000 OTC Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 076377-001 Jul 2, 2007 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis LAMISIL terbinafine hydrochloride CREAM;TOPICAL 020192-001 Dec 30, 1992 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis LAMISIL terbinafine hydrochloride GRANULE;ORAL 022071-002 Sep 28, 2007 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 078199-001 Jul 2, 2007 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

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Expired US Patents for TERBINAFINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis LAMISIL terbinafine hydrochloride TABLET;ORAL 020539-001 May 10, 1996 ➤ Sign Up ➤ Sign Up
Glaxosmithkline LAMISIL terbinafine hydrochloride CREAM;TOPICAL 020980-001 Mar 9, 1999 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Cons LAMISIL terbinafine hydrochloride SOLUTION;TOPICAL 020749-001 Oct 17, 1997 ➤ Sign Up ➤ Sign Up
Novartis LAMISIL AT terbinafine hydrochloride SOLUTION;TOPICAL 021124-001 Mar 17, 2000 ➤ Sign Up ➤ Sign Up
Novartis LAMISIL AT terbinafine hydrochloride SPRAY;TOPICAL 021124-002 Mar 17, 2000 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Cons LAMISIL terbinafine hydrochloride SOLUTION;TOPICAL 020749-001 Oct 17, 1997 ➤ Sign Up ➤ Sign Up
Novartis LAMISIL AT terbinafine hydrochloride SOLUTION;TOPICAL 021124-001 Mar 17, 2000 ➤ Sign Up ➤ Sign Up
Novartis LAMISIL AT terbinafine hydrochloride SPRAY;TOPICAL 021124-002 Mar 17, 2000 ➤ Sign Up ➤ Sign Up
Novartis LAMISIL AT terbinafine hydrochloride SOLUTION;TOPICAL 021124-001 Mar 17, 2000 ➤ Sign Up ➤ Sign Up
Novartis LAMISIL AT terbinafine hydrochloride SOLUTION;TOPICAL 021124-001 Mar 17, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Baxter
Colorcon
AstraZeneca
UBS
Boehringer Ingelheim
Teva
Argus Health
Cerilliant

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