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PLAVIX Drug Profile

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Plavix is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from eleven suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-one patent family members in forty-two countries.

The generic ingredient in PLAVIX is clopidogrel bisulfate. There are fifty-three drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.

Summary for Tradename: PLAVIX

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list11

Pharmacology for Tradename: PLAVIX

Clinical Trials for: PLAVIX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
PLAVIX
clopidogrel bisulfate
TABLET;ORAL020839-001Nov 17, 1997RXNo6,504,030*PED<disabled>Y<disabled>
Sanofi Aventis Us
PLAVIX
clopidogrel bisulfate
TABLET;ORAL020839-002Sep 20, 2007RXYes6,429,210*PED<disabled>Y<disabled>
Sanofi Aventis Us
PLAVIX
clopidogrel bisulfate
TABLET;ORAL020839-001Nov 17, 1997RXNo6,429,210*PED<disabled>Y<disabled>
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Expired Patents for Tradename: PLAVIX

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
PLAVIX
clopidogrel bisulfate
TABLET;ORAL020839-001Nov 17, 19974,529,596<disabled>
Sanofi Aventis Us
PLAVIX
clopidogrel bisulfate
TABLET;ORAL020839-001Nov 17, 19975,576,328*PED<disabled>
Sanofi Aventis Us
PLAVIX
clopidogrel bisulfate
TABLET;ORAL020839-002Sep 20, 20074,847,265*PED<disabled>
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Paragraph IV activity for: PLAVIX

Drugname Dosage Strength RLD Submissiondate
clopidogrel bisulfateTablets300 mgPlavix3/4/2009

International Patent Family for Tradename: PLAVIX

Country Document Number Estimated Expiration
Canada2334870<disabled in preview>
Hungary225871<disabled in preview>
Uruguay25693<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: PLAVIX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB99/001United Kingdom<disabled>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
8C0045Belgium<disabled>PRODUCT NAME: CLOPIDOGREL; REGISTRATION NO/DATE: EU/1/98/069/001 19980715
90035-0 98910359Sweden<disabled>PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715
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