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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, 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 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. Forty-eight suppliers are listed for this compound.

Summary for Generic Name: clopidogrel bisulfate

Tradenames:2
Patents:2
Applicants:20
NDAs:20
Drug Master File Entries: see list53
Suppliers / Packaging: see list48
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: clopidogrel bisulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Macleods Pharms Ltd
CLOPIDOGREL BISULFATE
clopidogrel bisulfate
TABLET;ORAL202928-001Feb 10, 2014RXNo► subscribe► subscribe
Sanofi Aventis Us
PLAVIX
clopidogrel bisulfate
TABLET;ORAL020839-001Nov 17, 1997RXNo6,429,210*PED► subscribeY► subscribe
Wockhardt Ltd
CLOPIDOGREL BISULFATE
clopidogrel bisulfate
TABLET;ORAL202266-001Aug 14, 2012RXNo► 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, 19975,576,328*PED► subscribe
Sanofi Aventis Us
PLAVIX
clopidogrel bisulfate
TABLET;ORAL020839-002Sep 20, 20074,847,265*PED► subscribe
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International Patent Family for Ingredient: clopidogrel bisulfate

Country Document Number Estimated Expiration
Uruguay25693► subscribe
Turkey200003417► subscribe
African Intellectual Property Organization (OAPI)11567► 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
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
/1998Austria► subscribePRODUCT NAME: CLOPIDOGREL-HYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/98/069/001 - EU/1/98/069/003 19980715
90035-0 98910359Sweden► 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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