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Details for Generic Name: terbinafine

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Terbinafine is the generic ingredient in three branded drugs marketed by Glaxosmithkline Cons, Novartis, Taro, 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-four NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-three 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 list23
Suppliers / Packaging: see list2

Tentative approvals for TERBINAFINE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORALEQ 250MG BASE

Clinical Trials for: terbinafine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roxane
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride
TABLET;ORAL077223-001Jul 2, 2007DISCNNo<disabled><disabled>
Mylan
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride
TABLET;ORAL077136-001Jul 2, 2007DISCNNo<disabled><disabled>
Mylan
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride
TABLET;ORAL077195-001Jul 2, 2007RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: terbinafine

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Cons
LAMISIL
terbinafine
GEL;TOPICAL020846-001Apr 29, 19986,005,001*PED<disabled>
Glaxosmithkline Cons
LAMISIL
terbinafine
GEL;TOPICAL020846-001Apr 29, 19984,680,291<disabled>
Novartis
LAMISIL AT
terbinafine
GEL;TOPICAL021958-001Jul 24, 20066,121,314<disabled>
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Non-Orange Book Patents for Generic Ingredient: terbinafine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,856,355 Pharmaceutical composition<disabled in preview>
6,005,001 Pharmaceutical composition<disabled in preview>
6,121,314 Pharmaceutical composition<disabled in preview>
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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