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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Colorcon
Covington
Cipla
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Healthtrust
Moodys
Novartis
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Generated: December 17, 2017

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Clopidogrel bisulfate - Generic Drug Details

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What are the generic sources for clopidogrel bisulfate and what is the scope of clopidogrel bisulfate freedom to operate?

Clopidogrel bisulfate
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Acme Labs, Actavis Totowa, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Gate Pharms, Macleods Pharms Ltd, Mylan Pharms Inc, Sciegen Pharms Inc, Sun Pharm Industries, Sun Pharma Global, Teva, Teva Pharms, Torrent Pharms Ltd, Wockhardt Ltd, Zydus Pharms Usa Inc, and Sanofi Aventis Us, 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.

Clopidogrel bisulfate has fifty-five patent family members in forty-three countries and eight supplementary protection certificates in six countries.

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

Pharmacology for clopidogrel bisulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharma GlobalCLOPIDOGREL BISULFATEclopidogrel bisulfateTABLET;ORAL090494-001May 17, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Wockhardt LtdCLOPIDOGREL BISULFATEclopidogrel bisulfateTABLET;ORAL202266-002Nov 20, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva PharmsCLOPIDOGREL BISULFATEclopidogrel bisulfateTABLET;ORAL090625-001May 17, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Wockhardt LtdCLOPIDOGREL BISULFATEclopidogrel bisulfateTABLET;ORAL202266-001Aug 14, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa IncCLOPIDOGREL BISULFATEclopidogrel bisulfateTABLET;ORAL201686-001Oct 10, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Cspc Ouyi Pharm CoCLOPIDOGREL BISULFATEclopidogrel bisulfateTABLET;ORAL204359-001Feb 2, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdCLOPIDOGREL BISULFATEclopidogrel bisulfateTABLET;ORAL091023-001May 17, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex IncCLOPIDOGREL BISULFATEclopidogrel bisulfateTABLET;ORAL076274-001May 17, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsPLAVIXclopidogrel bisulfateTABLET;ORAL020839-001Nov 17, 1997ABRXYesNo► Subscribe► SubscribeY► Subscribe
Sciegen Pharms IncCLOPIDOGREL BISULFATEclopidogrel bisulfateTABLET;ORAL204165-001Sep 15, 2014ABRXNoNo► Subscribe► 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 UsPLAVIXclopidogrel bisulfateTABLET;ORAL020839-002Sep 20, 2007► Subscribe► Subscribe
Sanofi Aventis UsPLAVIXclopidogrel bisulfateTABLET;ORAL020839-001Nov 17, 1997► Subscribe► Subscribe
Sanofi Aventis UsPLAVIXclopidogrel bisulfateTABLET;ORAL020839-001Nov 17, 1997► Subscribe► Subscribe
Sanofi Aventis UsPLAVIXclopidogrel bisulfateTABLET;ORAL020839-001Nov 17, 1997► Subscribe► Subscribe
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International Patent Family for Ingredient: clopidogrel bisulfate

Country Document Number Estimated Expiration
Canada2334870► Subscribe
Bulgaria104987► Subscribe
Colombia5040084► Subscribe
Estonia03972► Subscribe
China1305483► Subscribe
France2779726► Subscribe
Japan3641584► Subscribe
European Patent Office1087976► Subscribe
Germany69902536► Subscribe
South Africa200006386► 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
/1998Austria► SubscribePRODUCT NAME: CLOPIDOGREL-HYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/98/069/001 - EU/1/98/069/003 19980715
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
90035-0 98910359Sweden► SubscribePRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715
C0036France► SubscribePRODUCT 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
90002Netherlands► SubscribePRODUCT NAME: CLOPIDOGREL WATERSTOFSULFAAT; REGISTRATION NO/DATE: EU 1/98/069/001 - EU 1/98/069/003 19980715
90035Sweden► SubscribePRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715
C0036Belgium► SubscribePRODUCT 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
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Serving leading biopharmaceutical companies globally:

Cipla
Healthtrust
Citi
Deloitte
Colorcon
Dow
Johnson and Johnson
Chubb
Julphar
Fuji

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