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Generated: September 21, 2018

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Clopidogrel bisulfate - Generic Drug Details

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What are the generic drug sources for clopidogrel bisulfate and what is the scope of clopidogrel bisulfate patent protection?

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, Prinston 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-two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

Pharmacology for clopidogrel bisulfate
Synonyms for clopidogrel bisulfate
(+) 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 (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
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 clopidogrel bisulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Prinston Inc CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 206376-001 May 7, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Totowa CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 090307-001 May 28, 2013 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Wockhardt Ltd CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 202266-001 Aug 14, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 077665-001 May 17, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 091023-001 May 17, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ 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 clopidogrel bisulfate

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

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Supplementary Protection Certificates for clopidogrel bisulfate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
90035-0 98910359 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
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
/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:

Teva
Cipla
Healthtrust
Deloitte
Harvard Business School
Medtronic
Cantor Fitzgerald
Fuji
McKinsey

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