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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: see list2

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

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

Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
Status: Completed Condition: Onychomycosis

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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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
6,121,314 Pharmaceutical composition<disabled in preview>
5,856,355 Pharmaceutical composition<disabled in preview>
6,005,001 Pharmaceutical composition<disabled in preview>
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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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