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Baxter
AstraZeneca
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Mallinckrodt
Accenture
Covington
Colorcon
Deloitte
Dow

Generated: December 10, 2018

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PLAVIX Drug Profile

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Which patents cover Plavix, and what generic alternatives are available?

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

This drug has fifty-five patent family members in forty-three countries.

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

Drug patent expirations by year for PLAVIX
Synonyms for PLAVIX
(+) Clopidogrel Bisulfate
(+)-clopidogrel bisulfate
(+)-clopidogrel hydrogen sulfate
(+/-) Clopidogrel hydrogen sulfate
(+/-)-Clopidogrel hydrogen sulfate
(S)-( )-Methyl (2-chlorophenyl)(6,7-dihydro-4H-thieno(3,2-c)pyrid-5-yl)acetate bisulfate
(S)-(+)-Clopidogrel hydrogen sulfate
(S)-(+)-Clopidogrel hydrogensulfate, >=98% (HPLC)
(S)-(+)-Clopidogrel Sulfate
(S)-(+)-Methyl 2-(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)-2-(2-chlorophenyl)acetate hydrogen sulfate
(S)-(2-Chloro-phenyl)-(6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl)-acetic acid methyl ester sulfuric acid salt
(S)-methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate sulfate
(S)-METHYL-(2-CHLORO-PHENYL)-(6,7-DIHYDRO-4H-THIENO[3,2-C]PYRIDIN-5-YL)-ACETATE H2SO4
08I79HTP27
111GE004
120202-66-6
135046-48-9
144077-07-6
A19581
AB0012679
AB2000095
AC-2135
AC1L3GZZ
AK-58351
AKOS015900408
Ambap113665-84-2
AN-10793
AN-14258
ANW-47676
BB_SC-2102
BR-58351
C16H18ClNO6S2
CAS-135046-48-9
CCG-39568
CHEBI:3759
CHEMBL1083385
Clopidogrel hydrogen sulphate
Clopidogrel (hydrogen sulfate)
Clopidogrel (Plavix)
Clopidogrel bisulfate
Clopidogrel bisulfate (USAN)
Clopidogrel bisulfate [USAN:USP]
Clopidogrel Bisulfate [USAN]
Clopidogrel Bisulfate, pharmaceutical secondary standard; traceable to USP, PhEur
Clopidogrel bisulfate, United States Pharmacopeia (USP) Reference Standard
Clopidogrel bisulphate
Clopidogrel Bisulphate USP (Form II)
Clopidogrel for system suitability, European Pharmacopoeia (EP) Reference Standard
Clopidogrel hemisulfate
Clopidogrel hydrogen sulfate
Clopidogrel hydrogen sulfate, European Pharmacopoeia (EP) Reference Standard
clopidogrel hydrogen sulphate
Clopidogrel hydrogensulfate
CLOPIDOGREL SULFATE
Clopidogrel sulfate (JP17)
Clopidogrel sulfate tablets (JP17)
Clopidogrel sulphate
clopidogrel; sulfuric acid
Clopidogrelhydrogensulphate
CS-1882
CTK8B5120
D00769
DR002565
DSSTox_CID_26024
DSSTox_GSID_46024
DSSTox_RID_81297
DTXSID4046024
DV-7314
FC1269
FDEODCTUSIWGLK-RSAXXLAASA-N
FT-0603200
HE301021
HMS1922G16
HMS2093I13
HY-17459
Iscover
Iscover;Myogrel;Plavix
Isocover (TN)
J-006637
KS-1045
LS-152396
LS-172438
MCULE-2362021814
MDCO-157
Methyl (+)-(S)-alpha-(o-chlorophenyl)-6,7-dihydrothieno(3,2-c)pyridine-5(4H)-acetate, sulfate (1:1)
Methyl (2-chlorophenyl)(6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl)acetate hydrogen sulfate
methyl (2S)-2-(2-chlorophenyl)-2-(6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl)acetate; sulfuric acid
methyl (2S)-2-(2-chlorophenyl)-2-(6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl)acetate;sulfuric acid
methyl (2S)-2-(2-chlorophenyl)-2-{4H,5H,6H,7H-thieno[3,2-c]pyridin-5-yl}acetate; sulfuric acid
Methyl (S)-(+)-2-(2-Chlorophenyl)-2-[6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl]acetate Sulfate
methyl (S)-2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate sulfate
Methyl alphaS-(2-chlorophenyl)-6,7-dihydrothieno(3,2-c)pyridine-5(4H)-acetate sulfate (1:1)
MFCD00876395
MFCD05865229
MolPort-000-784-171
Myogrel
NCGC00159321-02
NCGC00163329-03
NSC-758613
NSC758613
Osvix
Pharmakon1600-01503710
Plavitor
Plavix (TN)
PM-103
RTR-004741
s1415
S65C842
SC-08806
SCHEMBL33556
SPECTRUM1503710
SR 25990C
SR-05000002068
SR-05000002068-1
SR-25990
SR-25990C
ST51053924
Thieno(3,2-c)pyridine-5(4H)-acetic acid, 6,7-dihydro-alpha-(2-chlorophenyl)-, methyl ester, (S)-, sulfate
Thieno(3,2-c)pyridine-5(4H)-acetic acid, alpha-(2-chlorophenyl)-6,7-dihydro-, methyl ester, (alphaS)-, sulfate (1:1)
Thieno(3,2-c)pyridine-5(4H)-acetic acid, alpha-(2-chlorophenyl)-6,7-dihydro-, methyl ester, (S)-, sulfate (1:1)
TL8000537
Tox21_111570
Tox21_111570_1
UNII-08I79HTP27
Y-9563
Z1550648767

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-002 Sep 20, 2007 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-001 Nov 17, 1997 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-002 Sep 20, 2007 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for PLAVIX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-002 Sep 20, 2007 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-001 Nov 17, 1997 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-001 Nov 17, 1997 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-001 Nov 17, 1997 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for PLAVIX
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 300 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for PLAVIX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0036 Belgium ➤ Sign Up 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
8C0045 Belgium ➤ Sign Up PRODUCT NAME: CLOPIDOGREL; REGISTRATION NO/DATE: EU/1/98/069/001 19980715
C0036 France ➤ Sign Up 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
90035 Sweden ➤ Sign Up PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715
C/GB99/001 United Kingdom ➤ Sign Up 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
/1998 Austria ➤ Sign Up PRODUCT NAME: CLOPIDOGREL-HYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/98/069/001 - EU/1/98/069/003 19980715
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Chinese Patent Office
UBS
Dow
Teva
Cantor Fitzgerald
QuintilesIMS
Express Scripts
Covington

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