➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School

Last Updated: September 28, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020839

Email this page to a colleague

« Back to Dashboard

NDA 020839 describes PLAVIX, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from three suppliers. Additional details are available on the PLAVIX profile page.

The generic ingredient in PLAVIX is clopidogrel bisulfate. There are fifty-four drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.
Summary for 020839
Applicant:Sanofi Aventis Us
Ingredient:clopidogrel bisulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 020839
Suppliers and Packaging for NDA: 020839
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PLAVIX clopidogrel bisulfate TABLET;ORAL 020839 NDA sanofi-aventis U.S. LLC 0024-1171 0024-1171-90 90 TABLET, FILM COATED in 1 BOTTLE (0024-1171-90)
PLAVIX clopidogrel bisulfate TABLET;ORAL 020839 NDA sanofi-aventis U.S. LLC 0024-1332 0024-1332-30 3 BLISTER PACK in 1 CARTON (0024-1332-30) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 020839
Tradename Dosage Ingredient NDA Submissiondate
PLAVIX TABLET;ORAL clopidogrel bisulfate 020839 2009-03-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Nov 17, 1997TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Sep 20, 2007TE:ABRLD:Yes

Expired US Patents for NDA 020839

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts

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 verification 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.