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Generated: November 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020839

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NDA 020839 describes PLAVIX, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from five suppliers. There are two patents protecting this drug and one Paragraph IV challenge. 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. Fifty-eight suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.
Summary for 020839
Tradename:PLAVIX
Applicant:Sanofi Aventis Us
Ingredient:clopidogrel bisulfate
Patents:2
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 Rebel Distributors Corp 21695-665 21695-665-30 30 TABLET, FILM COATED in 1 BOTTLE (21695-665-30)
PLAVIX clopidogrel bisulfate TABLET;ORAL 020839 NDA Rebel Distributors Corp 21695-665 21695-665-90 90 TABLET, FILM COATED in 1 BOTTLE (21695-665-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Nov 17, 1997TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Dec 10, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Dec 10, 2019Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Sep 20, 2007TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Dec 10, 2019Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 020839

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-001 Nov 17, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-002 Sep 20, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-001 Nov 17, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-001 Nov 17, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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McKinsey
Queensland Health
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Cantor Fitzgerald
Mallinckrodt
US Department of Justice
Express Scripts
Baxter
Healthtrust

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