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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Teva
Cantor Fitzgerald
Argus Health
Novartis
Cipla
Deloitte
Accenture
AstraZeneca

Generated: November 21, 2017

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Terbinafine - Generic Drug Details

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What are the generic drug sources for terbinafine and what is the scope of terbinafine patent protection?

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

There are twenty-six drug master file entries for terbinafine. One supplier is listed for this compound. There are four tentative approvals for this compound.

Tentative approvals for TERBINAFINE

Applicant Application No. Strength Dosage Form
u► SubscribeEQ 250MG BASETABLET; ORAL
u► SubscribeEQ 250MG BASETABLET;ORAL
u► SubscribeEQ 250MG BASETABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride
TABLET;ORAL076377-001Jul 2, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Novartis
LAMISIL AT
terbinafine hydrochloride
SOLUTION;TOPICAL021124-001Mar 17, 2000OTCYesYes► Subscribe► Subscribe► Subscribe
Glaxosmithkline Cons
LAMISIL
terbinafine
GEL;TOPICAL020846-001Apr 29, 1998DISCNNoNo► Subscribe► Subscribe► Subscribe
Novartis
LAMISIL AT
terbinafine hydrochloride
SPRAY;TOPICAL021124-002Mar 17, 2000OTCYesYes► Subscribe► Subscribe► Subscribe
Orchid Hlthcare
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride
TABLET;ORAL078163-001Jul 2, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride
TABLET;ORAL077195-001Jul 2, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Harris Pharm
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride
TABLET;ORAL077919-001Jul 2, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Novartis
LAMISIL
terbinafine hydrochloride
TABLET;ORAL020539-001May 10, 1996ABRXYesYes► Subscribe► Subscribe► Subscribe
Novartis
LAMISIL
terbinafine hydrochloride
CREAM;TOPICAL020192-001Dec 30, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe
Apotex
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride
TABLET;ORAL078199-001Jul 2, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: terbinafine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Cons
LAMISIL
terbinafine
GEL;TOPICAL020846-001Apr 29, 1998► Subscribe► Subscribe
Glaxosmithkline Cons
LAMISIL
terbinafine
GEL;TOPICAL020846-001Apr 29, 1998► Subscribe► Subscribe
Glaxosmithkline Cons
LAMISIL
terbinafine
GEL;TOPICAL020846-001Apr 29, 1998► Subscribe► Subscribe
Novartis
LAMISIL AT
terbinafine
GEL;TOPICAL021958-001Jul 24, 2006► Subscribe► Subscribe
Novartis
LAMISIL AT
terbinafine
GEL;TOPICAL021958-001Jul 24, 2006► Subscribe► Subscribe
Novartis
LAMISIL AT
terbinafine
GEL;TOPICAL021958-001Jul 24, 2006► Subscribe► Subscribe
Glaxosmithkline Cons
LAMISIL
terbinafine
GEL;TOPICAL020846-001Apr 29, 1998► Subscribe► Subscribe
Glaxosmithkline Cons
LAMISIL
terbinafine
GEL;TOPICAL020846-001Apr 29, 1998► Subscribe► Subscribe
Glaxosmithkline Cons
LAMISIL
terbinafine
GEL;TOPICAL020846-001Apr 29, 1998► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

AstraZeneca
US Army
US Department of Justice
McKesson
Teva
Federal Trade Commission
Johnson and Johnson
Mallinckrodt
Colorcon
Medtronic

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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