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Profile for Tradename: LAMISIL AT

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Lamisil At is a drug marketed by Novartis and is included in two NDAs. It is available from two suppliers. There is one patent protecting this drug.

The generic ingredient in LAMISIL AT is terbinafine hydrochloride. There are twenty-three drug master file entries for this compound. Five suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the terbinafine hydrochloride profile page.

Summary for Tradename: LAMISIL AT

Patents:1
Applicants:1
NDAs:2
Suppliers / Packagers: see list6

Clinical Trials for: LAMISIL AT

Safety and Pharmacokinetics of Terbinafine Hydrogen Chloride (HCl) Nail Lacquer in Patients With Onychomycosis
Status: Completed Condition: Onychomycosis/Onycholysis and Tinea Pedis

Iontophoretic Application of Terbinafine Gel to the Large Toe Nail
Status: Completed Condition: Onychomycosis

Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fed Conditions
Status: Completed Condition: Healthy

Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fasting Conditions
Status: Completed Condition: Fasting

Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Status: Completed Condition: Tinea Capitis

Optimizing the Treatment of Toenail Onychomycosis Using a New Transdermal Patch Combined With Terbinafine/Ketoconazole
Status: Recruiting Condition: Onychomycosis

Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis
Status: Completed Condition: Onychomycosis

Bioequivalence Study for Terbinafine 250 mg
Status: Completed Condition: Mycoses

Terbinafine HCl 250 mg Tablet Under Fasting Conditions
Status: Completed Condition: Healthy

Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions
Status: Completed Condition: Healthy

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
LAMISIL AT
terbinafine
GEL;TOPICAL021958-001Jul 24, 2006OTCYes5,681,849*PED<disabled>Y<disabled>
Novartis
LAMISIL AT
terbinafine hydrochloride
SOLUTION;TOPICAL021124-001Mar 17, 2000OTCYes5,681,849*PED<disabled>Y<disabled>
Novartis
LAMISIL AT
terbinafine hydrochloride
SPRAY;TOPICAL021124-002Mar 17, 2000OTCYes5,681,849*PED<disabled>Y<disabled>
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Expired Patents for Tradename: LAMISIL AT

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
Novartis
LAMISIL AT
terbinafine
GEL;TOPICAL021958-001Jul 24, 20065,681,849*PED<disabled>
Novartis
LAMISIL AT
terbinafine hydrochloride
SPRAY;TOPICAL021124-002Mar 17, 20004,680,291<disabled>
Novartis
LAMISIL AT
terbinafine hydrochloride
SPRAY;TOPICAL021124-002Mar 17, 20006,121,314*PED<disabled>
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Non-Orange Book Patents for Tradename: LAMISIL AT

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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