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Clopidogrel bisulfate - Generic Drug Details

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Clopidogrel bisulfate is the generic ingredient in two branded drugs marketed by Roxane, Actavis Totowa, Gate Pharms, Dr Reddys Labs Ltd, Accord Hlthcare, Teva Pharms, Macleods Pharms Ltd, Sun Pharm Inds, Sanofi Aventis Us, Aurobindo Pharma Ltd, Torrent Pharms Ltd, Amneal Pharms, Cspc Ouyi Pharm Co, Mylan Pharms Inc, Sciegen Pharms Inc, Wockhardt Ltd, Dr Reddys Labs Inc, Apotex Inc, Zydus Pharms Usa Inc, Sun Pharma Global, and Teva, and is included in twenty-one NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are fifty-three drug master file entries for clopidogrel bisulfate. Fifty suppliers are listed for this compound.

Summary for Generic Name: clopidogrel bisulfate

Tradenames:2
Patents:2
Applicants:21
NDAs:21
Drug Master File Entries: see list53
Suppliers / Packagers: see list50
Bulk Api Vendors: see list75
Clinical Trials: see list321
Patent Applications: see list1,975
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:clopidogrel bisulfate at DailyMed

Pharmacology for Ingredient: clopidogrel bisulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms
CLOPIDOGREL BISULFATE
clopidogrel bisulfate
TABLET;ORAL203751-001Apr 11, 2014RXNoNo► subscribe► subscribe
Sanofi Aventis Us
PLAVIX
clopidogrel bisulfate
TABLET;ORAL020839-002Sep 20, 2007RXYesYes6,504,030*PED► subscribeY► subscribe
Sciegen Pharms Inc
CLOPIDOGREL BISULFATE
clopidogrel bisulfate
TABLET;ORAL204165-002Sep 15, 2014RXNoNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: clopidogrel bisulfate

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► subscribe
Sanofi Aventis Us
PLAVIX
clopidogrel bisulfate
TABLET;ORAL020839-001Nov 17, 19974,847,265*PED► subscribe
Sanofi Aventis Us
PLAVIX
clopidogrel bisulfate
TABLET;ORAL020839-001Nov 17, 19975,576,328*PED► subscribe
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International Patent Family for Ingredient: clopidogrel bisulfate

Country Document Number Estimated Expiration
Japan2002518399► subscribe
Poland201894► subscribe
Czech Republic299654► subscribe
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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: CLOPIDOGREL BISULFATE

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

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