PLAVIX Drug Patent Profile

When do Plavix patents expire, and when can generic versions of Plavix launch?

Plavix is a drug marketed by Sanofi Aventis Us and is included in one NDA.

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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Plavix

A generic version of PLAVIX was approved as clopidogrel bisulfate by DR REDDYS on January 14^th, 2008.

Summary for PLAVIX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	222
Patent Applications:	2,900
Drug Prices:	Drug price information for PLAVIX
Drug Sales Revenues:	Drug sales revenues for PLAVIX
What excipients (inactive ingredients) are in PLAVIX?	PLAVIX excipients list
DailyMed Link:	PLAVIX at DailyMed

See drug prices for PLAVIX

See drug sales revenues for PLAVIX

Recent Clinical Trials for PLAVIX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Lady Reading Hospital, Pakistan	Phase 3
Pakistan Chest Society, Pakistan	Phase 3
ClinPharmInvest, LLC	Phase 1

See all PLAVIX clinical trials

Pharmacology for PLAVIX

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

Paragraph IV (Patent) Challenges for PLAVIX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PLAVIX	Tablets	clopidogrel bisulfate	300 mg	020839	1	2009-03-04

US Patents and Regulatory Information for PLAVIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-001	Nov 17, 1997	AB	RX	Yes	No
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-002	Sep 20, 2007	AB	RX	Yes	No

Expired US Patents for PLAVIX

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
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-001	Nov 17, 1997
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-001	Nov 17, 1997
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-002	Sep 20, 2007

International Patents for PLAVIX

See the table below for patents covering PLAVIX around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	197909	PROCESS FOR PRODUCING THE DEXTROROTATING ENANTHIOMER AND SALTS OF METHYL-ALPHA-SQUARE BRACKETS OPEN 5-(4,5,6,7-TETRAHYDROTHIENO SQUARE BRACKETS OPEN 3,2-C SQUARE BRACKETS CLOSED PYRIDYL) SQUARE BRACKETS CLOSED-ALPHA-(2-CHLOROPHENYL)-ACETATE AND PHARMACEUTICAL COMPOSITIONS COMPRISING THESE COMPOUNDS
Ireland	880273
Finland	880720
African Intellectual Property Organization (OAPI)	8808

Supplementary Protection Certificates for PLAVIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0281459	98C0036	France		PRODUCT NAME: CLOPIDOGREL HYDROGENE SULFATE; REGISTRATION NO/DATE IN FRANCE: EU/1/98 /069/001 DU 19980715; REGISTRATION NO/DATE AT EEC: DU EU/1-/98/069/001
0281459	35/1998	Austria		PRODUCT NAME: CLOPIDOGREL-HYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/98/069/001 - EU/1/98/069/003 19980715
0281459	9890035-0 98910359	Sweden		PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715
0281459	9890035	Sweden		PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715