PLAVIX Drug Patent Profile

Which patents cover Plavix, and what generic alternatives are available?

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-four 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:	219
Patent Applications:	4,455
Formulation / Manufacturing:	see details
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
Mercy Health Ohio	Phase 3
Mayo Hospital Lahore	Phase 4
Sarmad Zahoor	Phase 4

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

Anatomical Therapeutic Chemical (ATC) Classes for PLAVIX

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

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

International Patents for PLAVIX

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

Country	Patent Number	Title	Estimated Expiration
Czechoslovakia	246082	METHOD OF THIENO (3,2-C)PYRIDINE'S NEW DERIVATIVES PRODUCTION
Hungary	225871	NOVEL POLYMORPHIC CLOPIDOGREL HYDROGENESULPHATE FORM, PROCESS FOR ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THIS
Hungary	T47291
Norway	832530
Ireland	66922	Dextrorotatory enantiomer of alpha-(4,5,6,7-tetrahydrothieno [3,2-c]pyrid-5-yl) (2-chlorophenyl)methyl acetate a process for its preparation and the pharmaceutical compositions containing it
Poland	142272

Supplementary Protection Certificates for PLAVIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0281459	35/1998	Austria		PRODUCT NAME: CLOPIDOGREL-HYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/98/069/001 - EU/1/98/069/003 19980715
0281459	SPC/GB99/001	United Kingdom		PRODUCT NAME: CLOPIDOGREL HYDROGEN SULPHATE, THE DEXTROROTATORY ISOMER OF ALPHA-(4,5,6,7-TETRAHYDROTHIENO(3,2-C)PYRID-5-YL)(2-CHLOROPHENYL) METHYL ACETATE AS THE HYDROGEN SULPHATE SALT; REGISTERED: UK EU/1/98/069/001 19980715; UK EU/1/98/069/002 19980715; UK EU/1/98/069/003 19980715
0281459	C990002	Netherlands		PRODUCT NAME: CLOPIDOGREL WATERSTOFSULFAAT; REGISTRATION NO/DATE: EU 1/98/069/001 - EU 1/98/069/003 19980715
0281459	9890035	Sweden		PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715
0281459	098C0045	Belgium		PRODUCT NAME: CLOPIDOGREL; REGISTRATION NO/DATE: EU/1/98/069/001 19980715
0302769	98C0036	Belgium		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