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Terbinafine - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for terbinafine?

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, 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-four drug master file entries for terbinafine. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: terbinafine

Tradenames:3
Patents:1
Applicants:17
NDAs:24
Drug Master File Entries: see list24
Suppliers / Packagers: see list1
Bulk Api Vendors: see list58
Clinical Trials: see list14
Patent Applications: see list5,367
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:terbinafine at DailyMed

Tentative approvals for TERBINAFINE

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET; ORALEQ 250MG BASE
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
LAMISIL
terbinafine hydrochloride
CREAM;TOPICAL020980-001Mar 9, 1999OTCYesYes► Subscribe► Subscribe
Gedeon Richter Usa
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride
TABLET;ORAL077065-001Jul 2, 2007DISCNNoNo► Subscribe► Subscribe
Novartis
LAMISIL AT
terbinafine hydrochloride
SPRAY;TOPICAL021124-002Mar 17, 2000OTCYesYes► Subscribe► Subscribe
Glaxosmithkline Cons
LAMISIL
terbinafine
GEL;TOPICAL020846-001Apr 29, 1998DISCNNoNo► Subscribe► Subscribe
Novartis
LAMISIL
terbinafine hydrochloride
TABLET;ORAL020539-001May 10, 1996RXYesYes► 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
Novartis
LAMISIL AT
terbinafine
GEL;TOPICAL021958-001Jul 24, 20065,856,355*PED► Subscribe
Glaxosmithkline Cons
LAMISIL
terbinafine
GEL;TOPICAL020846-001Apr 29, 19984,680,291► Subscribe
Glaxosmithkline Cons
LAMISIL
terbinafine
GEL;TOPICAL020846-001Apr 29, 19986,005,001*PED► Subscribe
Glaxosmithkline Cons
LAMISIL
terbinafine
GEL;TOPICAL020846-001Apr 29, 19986,121,314*PED► Subscribe
Novartis
LAMISIL AT
terbinafine
GEL;TOPICAL021958-001Jul 24, 20065,681,849*PED► Subscribe
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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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