Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

UBS
Mallinckrodt
Cerilliant
Accenture
Argus Health
Teva
Cantor Fitzgerald
Farmers Insurance
Moodys

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020539

« Back to Dashboard

NDA 020539 describes LAMISIL, which is a drug marketed by Glaxosmithkline, Novartis, and Glaxosmithkline Cons, and is included in eight NDAs. It is available from three suppliers. Additional details are available on the LAMISIL profile page.

The generic ingredient in LAMISIL is terbinafine. There are twenty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the terbinafine profile page.
Summary for 020539
Tradename:LAMISIL
Applicant:Novartis
Ingredient:terbinafine hydrochloride
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 020539
Ingredient-typeAllylamine
Suppliers and Packaging for NDA: 020539
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMISIL terbinafine hydrochloride TABLET;ORAL 020539 NDA Novartis Pharmaceuticals Corporation 0078-0179 N 0078-0179-05
LAMISIL terbinafine hydrochloride TABLET;ORAL 020539 NDA Novartis Pharmaceuticals Corporation 0078-0179 N 0078-0179-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:May 10, 1996TE:ABRLD:Yes

Expired US Patents for NDA 020539

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis LAMISIL terbinafine hydrochloride TABLET;ORAL 020539-001 May 10, 1996 ➤ Sign Up ➤ Sign Up
Novartis LAMISIL terbinafine hydrochloride TABLET;ORAL 020539-001 May 10, 1996 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Citi
Mallinckrodt
Johnson and Johnson
Chinese Patent Office
Chubb
Fuji
Healthtrust
Baxter
QuintilesIMS

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.