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

Serving hundreds of leading biopharmaceutical companies globally:

Citi
Fuji
Boehringer Ingelheim
Colorcon
Cipla
QuintilesIMS
Healthtrust
Mallinckrodt
Teva

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020261

« Back to Dashboard

NDA 020261 describes LESCOL, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the LESCOL profile page.

The generic ingredient in LESCOL is fluvastatin sodium. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fluvastatin sodium profile page.
Summary for 020261
Tradename:LESCOL
Applicant:Novartis
Ingredient:fluvastatin sodium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020261
Suppliers and Packaging for NDA: 020261
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LESCOL fluvastatin sodium CAPSULE;ORAL 020261 NDA Physicians Total Care, Inc. 54868-3329 E 54868-3329-0
LESCOL fluvastatin sodium CAPSULE;ORAL 020261 NDA Physicians Total Care, Inc. 54868-4224 E 54868-4224-0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Dec 31, 1993TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 40MG BASE
Approval Date:Dec 31, 1993TE:RLD:Yes

Expired US Patents for NDA 020261

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-002 Dec 31, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-002 Dec 31, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-001 Dec 31, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-001 Dec 31, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
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:

Argus Health
Fish and Richardson
Johnson and Johnson
QuintilesIMS
Baxter
Dow
US Department of Justice
Cipla
Queensland Health

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.