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Last Updated: July 5, 2022

PLAVIX Drug Patent Profile


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When do Plavix patents expire, and when can generic versions of Plavix launch?

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. Thirty-eight 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 14th, 2008.

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Drug patent expirations by year for PLAVIX
Drug Prices for PLAVIX

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Drug Sales Revenue Trends for PLAVIX

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Recent Clinical Trials for PLAVIX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
International St. Mary's HospitalPhase 4
Bucheon St. Mary's HospitalPhase 4
Gangnam Severance HospitalPhase 4

See all PLAVIX clinical trials

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-002 Sep 20, 2007 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for PLAVIX

International Patents for PLAVIX

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

Country Patent Number Title Estimated Expiration
Finland 832543 See Plans and Pricing
Argentina 014854 POLIMORFO CRISTALINO DEL HIDROGENOSULFATO DE CLOPIDROGREL (FORMA2) (+)-(S)-ALFA-(2-CLOROFENIL)-4,5,6,7-TETRAHIDROTIENO[3,2-C]PIRIDINIL-5-ACETATO DE METILO ,PROCEDIMIENTO PARA SU PREPARACIoN Y COMPOSICIoN FARMAC√ČUTICA QUE LO CONTIENE See Plans and Pricing
Eurasian Patent Organization 200001187 See Plans and Pricing
Australia 1663783 See Plans and Pricing
Spain 2071621 See Plans and Pricing
Denmark 157552 See Plans and Pricing
Canada 2334870 FORME POLYMORPHE DE L'HYDROGENOSULFATE DE CLOPIDOGREL (POLYMORPHIC FORM OF CLOPIDOGREL HYDROGEN SULPHATE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PLAVIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0281459 9890035-0 98910359 Sweden See Plans and Pricing PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715
0281459 C990002 Netherlands See Plans and Pricing PRODUCT NAME: CLOPIDOGREL WATERSTOFSULFAAT; REGISTRATION NO/DATE: EU 1/98/069/001 - EU 1/98/069/003 19980715
0281459 098C0045 Belgium See Plans and Pricing PRODUCT NAME: CLOPIDOGREL; REGISTRATION NO/DATE: EU/1/98/069/001 19980715
0281459 35/1998 Austria See Plans and Pricing PRODUCT NAME: CLOPIDOGREL-HYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/98/069/001 - EU/1/98/069/003 19980715
0281459 98C0036 France See Plans and Pricing 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
0281459 SPC/GB99/001 United Kingdom See Plans and Pricing 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 9890035 Sweden See Plans and Pricing PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Boehringer Ingelheim
Dow
Baxter
Colorcon

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 verification 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.