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Generated: April 26, 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 six 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-three drug master file entries for this compound. Fifty-five 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
Therapeutic Class:	Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020839

Mechanism of Action	P2Y12 Receptor Antagonists Cytochrome P450 2C8 Inhibitors
Physiological Effect	Decreased Platelet Aggregation

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	E	21695-665-30
PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839	NDA	Rebel Distributors Corp	21695-665	E	21695-665-90

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 75MG BASE
Approval Date:	Nov 17, 1997	TE:	AB	RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Dec 10, 2019	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	➤ Sign Up	Patent Expiration:	Dec 10, 2019	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 300MG BASE
Approval Date:	Sep 20, 2007	TE:	AB	RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Dec 10, 2019	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 020839

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

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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. 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.