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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Federal Trade Commission
AstraZeneca
Farmers Insurance
Fuji
Baxter
Chubb
Boehringer Ingelheim
QuintilesIMS

Generated: January 20, 2018

DrugPatentWatch Database Preview

Terbinafine hydrochloride - Generic Drug Details

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What are the generic drug 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-six 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
➤ Subscribe➤ SubscribeEQ 250MG BASETABLET; ORAL
➤ Subscribe➤ SubscribeEQ 250MG BASETABLET;ORAL
➤ Subscribe➤ SubscribeEQ 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
Apotex TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 078199-001 Jul 2, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Orchid Hlthcare TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 078163-001 Jul 2, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis LAMISIL AT terbinafine hydrochloride SPRAY;TOPICAL 021124-002 Mar 17, 2000 OTC Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Taro TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride CREAM;TOPICAL 077511-001 Jul 2, 2007 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Breckenridge Pharm TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077714-001 Jun 4, 2010 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Dr Reddys Labs Inc TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 076390-001 Jul 2, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Wockhardt TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 078229-001 Jul 2, 2007 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis LAMISIL AT terbinafine hydrochloride SOLUTION;TOPICAL 021124-001 Mar 17, 2000 OTC Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gedeon Richter Usa TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077065-001 Jul 2, 2007 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 076377-001 Jul 2, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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
Glaxosmithkline Cons LAMISIL terbinafine hydrochloride SOLUTION;TOPICAL 020749-001 Oct 17, 1997 ➤ Subscribe ➤ Subscribe
Novartis LAMISIL AT terbinafine hydrochloride SPRAY;TOPICAL 021124-002 Mar 17, 2000 ➤ Subscribe ➤ Subscribe
Glaxosmithkline LAMISIL terbinafine hydrochloride CREAM;TOPICAL 020980-001 Mar 9, 1999 ➤ Subscribe ➤ Subscribe
Novartis LAMISIL AT terbinafine hydrochloride SOLUTION;TOPICAL 021124-001 Mar 17, 2000 ➤ Subscribe ➤ Subscribe
Novartis LAMISIL terbinafine hydrochloride TABLET;ORAL 020539-001 May 10, 1996 ➤ Subscribe ➤ Subscribe
Novartis LAMISIL terbinafine hydrochloride TABLET;ORAL 020539-001 May 10, 1996 ➤ Subscribe ➤ Subscribe
Novartis LAMISIL AT terbinafine hydrochloride SPRAY;TOPICAL 021124-002 Mar 17, 2000 ➤ Subscribe ➤ Subscribe
Novartis LAMISIL AT terbinafine hydrochloride SPRAY;TOPICAL 021124-002 Mar 17, 2000 ➤ Subscribe ➤ Subscribe
Glaxosmithkline LAMISIL terbinafine hydrochloride CREAM;TOPICAL 020980-001 Mar 9, 1999 ➤ Subscribe ➤ Subscribe
Novartis LAMISIL AT terbinafine hydrochloride SOLUTION;TOPICAL 021124-001 Mar 17, 2000 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Moodys
US Department of Justice
McKesson
Teva
Farmers Insurance
Daiichi Sankyo
Chubb
McKinsey

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 verifification 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.

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