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Profile for Tradename: LAMISIL

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Lamisil is a drug marketed by Novartis and Glaxosmithkline Cons and is included in eight NDAs. It is available from four suppliers.

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

Summary for Tradename: LAMISIL

Patents:0
Applicants:2
NDAs:8
Suppliers / Packagers: see list14

Pharmacology for Tradename: LAMISIL

Ingredient-typeAllylamine
Drug ClassAllylamine Antifungal

Clinical Trials for: LAMISIL

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

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 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

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

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

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

TDT 067 Open Label Multi-Dose Onychomycosis Study
Status: Completed Condition: Onychomycosis

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
terbinafine hydrochloride
TABLET;ORAL020539-001May 10, 1996RXYes<disabled><disabled>
Novartis
LAMISIL
terbinafine hydrochloride
CREAM;TOPICAL020192-001Dec 30, 1992DISCNNo<disabled><disabled>
Novartis
LAMISIL
terbinafine hydrochloride
GRANULE;ORAL022071-001Sep 28, 2007RXNo<disabled><disabled>
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Expired Patents for Tradename: LAMISIL

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
LAMISIL
terbinafine hydrochloride
TABLET;ORAL020539-001May 10, 19964,680,291<disabled>
Glaxosmithkline Cons
LAMISIL
terbinafine
GEL;TOPICAL020846-001Apr 29, 19986,121,314*PED<disabled>
Novartis
LAMISIL
terbinafine hydrochloride
CREAM;TOPICAL020980-001Mar 9, 19994,680,291<disabled>
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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.

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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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