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Generated: April 26, 2019

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PLAVIX Drug 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. 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. Sixty 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
(+) Clopidogrel Bisulfate
(+)-(S)-(2-Chlorophenyl) (6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl)acetic acid methyl ester
(+)-(S)-2-(2-chlorophenyl)-(6,7-dihydro-4H-thieno[3,2-c]pyrid-5-yl)acetic acid methyl ester
(+)-(S)-Clopidogrel
(+)-(S)-Methyl 2-(2-chlorophenyl)-2-(4,5,6,7-tetrahydrothieno[3,2-c ] pyridin-5-yl) acetate monosulfate
(+)-Clopidogrel
(+)-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
(S)-(+)-Clopidogrel hydrogensulfate, >=98% (HPLC)
(S)-(+)-Clopidogrel hydrogensulfate, 98%
(S)-(+)-Clopidogrel Sulfate
(S)-(+)-Methyl (2-chlorophenyl)-(6,7-dihydro-4H-thieno[3,2-c]pyrid-5-yl)acetate
(S)-(+)-Methyl (2-chlorophenyl)(6,7-dihydro-4H-thieno[3,2-c]pyrid-5-yl)acetate
(S)-(+)-Methyl 2-(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)-2-(2-chlorophenyl)acetate hydrogen sulfate
(S)-Clopidogrel
(S)-Methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate
(S)-methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate sulfate
(S)-METHYL 2-(2-CHLOROPHENYL)-2-(6,7-DIHYDROTHIENO[3,2-C]PYRIDINE-5(4H)-YL)ACETATE
(S)-METHYL-(2-CHLORO-PHENYL)-(6,7-DIHYDRO-4H-THIENO[3,2-C]PYRIDIN-5-YL)-ACETATE H2SO4
08I79HTP27
111GE004
113665-84-2
120202-66-6
135046-48-9
144077-07-6
A19581
A74586SNO7
AB00053786_09
AB00053786_10
AB00053786-07
AB00053786-08
AB0012679
AB1011824
AB2000095
AC-19024
AC-2135
AC1L1TKZ
AC1L3GZZ
AC1Q41I9
AJ-90179
AKOS005504280
AKOS015900408
AN-10793
AN-14258
ANW-47676
API0002073
BBL010770
BDBM50318910
BDBM50397662
BIDD:GT0284
BR-58351
BRD-K27721098-065-02-9
BRD-K27721098-065-05-2
BSPBio_003211
C16H18ClNO6S2
CAS-135046-48-9
CC0015
CCG-221243
CCG-39568
CGE
CHEBI:3759
CHEBI:37941
CHEMBL1083385
CHEMBL1771
clopidogrel
Clopidogrel hydrogen sulphate
Clopidogrel (hydrogen sulfate)
Clopidogrel (Plavix)
Clopidogrel (TN)
Clopidogrel (USP/INN)
Clopidogrel [BAN:INN]
Clopidogrel [INN:BAN]
Clopidogrel 1A Pharma
Clopidogrel Acino
Clopidogrel bisulfate
Clopidogrel bisulfate (USAN)
Clopidogrel bisulfate [USAN:USP]
Clopidogrel Bisulfate [USAN]
Clopidogrel Bisulfate, Pharmaceutical Secondary Standard; Certified Reference Material
Clopidogrel bisulfate, United States Pharmacopeia (USP) Reference Standard
Clopidogrel bisulphate
Clopidogrel Bisulphate USP (Form II)
Clopidogrel BMS
Clopidogrel for system suitability, European Pharmacopoeia (EP) Reference Standard
Clopidogrel hemisulfate
Clopidogrel Hexal
Clopidogrel hydrogen sulfate
Clopidogrel hydrogen sulfate, European Pharmacopoeia (EP) Reference Standard
clopidogrel hydrogen sulphate
Clopidogrel hydrogensulfate
Clopidogrel ratiopharm GmbH
CLOPIDOGREL SULFATE
Clopidogrel sulfate (JP17)
Clopidogrel sulfate tablets (JP17)
Clopidogrel sulphate
Clopidogrel Teva (hydrogen sulphate)
Clopidogrel USP Related Compound A
Clopidogrel Winthrop
clopidogrel, (+)(S)-isomer
clopidogrel; sulfuric acid
Clopidogrelhydrogensulphate
Clopidogrelum
CPD000550475
CS-0656
CS-1882
CTK6I6432
CTK8B5120
D00769
D07729
DB00758
DivK1c_000787
DS-13362
DSSTox_CID_26024
DSSTox_GSID_46024
DSSTox_RID_81297
DTXSID4046024
DTXSID6022848
DV-7314
FC1269
FDEODCTUSIWGLK-RSAXXLAASA-N
FT-0602596
FT-0603200
GKTWGGQPFAXNFI-HNNXBMFYSA-N
GTPL7150
HMS1922G16
HMS2090O21
HMS2093I13
HMS2234N16
HMS3259B08
HMS3715J08
HMS502H09
HSDB 7430
HY-15283
HY-17459
IDI1_000787
Iscover
Iscover;Myogrel;Plavix
Isocover
Isocover (TN)
J-006637
KBio1_000787
KBio2_000545
KBio2_003113
KBio2_005681
KBio3_002431
KBioGR_000689
KBioSS_000545
KS-00000K9F
KS-1045
LS-152396
LS-172232
LS-172438
MCULE-2362021814
MCULE-9061369538
MDCO-157
methyl (+)-(S)-alpha-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate
methyl (+)-(s)-alpha-(o-chlorophenyl)-6,7-dihydrothieno-[3,2-c]pyridine-5(4h)-acetate
Methyl (+)-(S)-alpha-(o-chlorophenyl)-6,7-dihydrothieno(3,2-c)pyridine-5(4H)-acetate
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 (2-chlorophenyl)(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate
Methyl (2-chlorophenyl)(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate (H2SO4)
methyl (2S)-(2-chlorophenyl)(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate
methyl (2S)-(2-chlorophenyl)(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)ethanoate
methyl (2S)-2-(2-chlorophenyl)-2-(6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl)acetate
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
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)-(+)-alpha-(o-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridin-5(4H)-acetate
methyl (S)-2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate
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)
methyl-(S)-(+)-(2-chlorophenyl)-2-(6,7-dihydro-4H-thieno[3,2-c]pyridine-5-yl)-acetate
methyl(+)-(s)-alpha-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4h) acetate
MFCD00866627
MFCD05865229
MLS001165708
MLS001195633
MLS001304711
MLS006011891
MolPort-000-784-171
MolPort-002-885-817
Myogrel
NC00703
NCGC00159321-02
NCGC00163329-02
NCGC00163329-03
NCGC00163329-04
NINDS_000787
NSC-748298
NSC-758613
NSC748298
NSC758613
Osvix
Pharmakon1600-01503710
Plavitor
Plavix (TN)
Plavix®
PM-103
R 130964
RT-012071
RTR-004741
s1415
S65C842
SAM002589956
SBI-0052755.P002
SC-08806
SCHEMBL33556
SCHEMBL4769
SMR000550475
SPBio_000463
Spectrum_000105
SPECTRUM1503710
Spectrum2_000512
Spectrum3_001606
Spectrum4_000175
SR 25990
SR 25990C
SR-05000002068
SR-05000002068-1
SR-25990
SR-25990C
STK580572
SW219457-1
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)-
Thieno(3,2-c)pyridine-5(4H)-acetic acid, alpha-(2-chlorophenyl)-6,7-dihydro-, methyl ester, (S)-, sulfate (1:1)
Thieno[3,2-c]pyridine-5(4H)-acetic acid, .alpha.-(2-chlorophenyl)-6,7-dihydro-, methyl ester, (.alpha.S)-
Thieno[3,2-c]pyridine-5(4H)-acetic acid, alpha-(2-chlorophenyl)-6,7-dihydro-, methyl ester, (alphaS)-
Thrombo
TL8000400
TL8000537
Tox21_111570
Tox21_111570_1
UNII-08I79HTP27
UNII-A74586SNO7
W-5322
Y-9563
Z1550648767
ZINC34781704
Zyllt

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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0281459 SPC/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
0281459 98C0036 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
0281459 35/1998 Austria ➤ Sign Up PRODUCT NAME: CLOPIDOGREL-HYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/98/069/001 - EU/1/98/069/003 19980715
0281459 098C0045 Belgium ➤ Sign Up PRODUCT NAME: CLOPIDOGREL; REGISTRATION NO/DATE: EU/1/98/069/001 19980715
0281459 9890035-0 98910359 Sweden ➤ Sign Up PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715
0281459 9890035 Sweden ➤ Sign Up 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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McKinsey

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