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Last Updated: December 12, 2019

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Clopidogrel bisulfate - Generic Drug Details

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What are the generic sources for clopidogrel bisulfate and what is the scope of freedom to operate?

Clopidogrel bisulfate is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Acme Labs, Actavis Totowa, Amneal Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Cadila, Celltrion, Cspc Ouyi, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva, Torrent Pharms Ltd, 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.

Clopidogrel bisulfate has fifty-five patent family members in forty-three countries.

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

Drug Prices for clopidogrel bisulfate

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Drug Sales Revenue Trends for clopidogrel bisulfate

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Recent Clinical Trials for clopidogrel bisulfate

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SponsorPhase
Xinhua Hospital, Shanghai Jiao Tong University School of MedicineN/A
The First Affiliated Hospital with Nanjing Medical UniversityPhase 4
CKD Pharmaceutical LimitedPhase 4

See all clopidogrel bisulfate clinical trials

Recent Litigation for clopidogrel bisulfate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Sanofi-Aventis v. Sun Pharmaceutical Industries Ltd.2008-07-11
APOTEX INC. v. LEAVITT2008-04-23
United States v. BRISTOL MYERS SQUIBB COMPANY2007-05-30

See all clopidogrel bisulfate litigation

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
(S)-(+)-Clopidogrel hydrogensulfate, >=98% (HPLC)
(S)-(+)-Clopidogrel hydrogensulfate, 98%
(S)-(+)-Clopidogrel Sulfate
(S)-(+)-Methyl 2-(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)-2-(2-chlorophenyl)acetate hydrogen sulfate
(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
AKOS015900408
AN-10793
AN-14258
ANW-47676
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; Certified Reference Material
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
DSSTox_CID_26024
DSSTox_GSID_46024
DSSTox_RID_81297
DTXSID4046024
DV-7314
FC1269
FDEODCTUSIWGLK-RSAXXLAASA-N
FT-0603200
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)
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
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)-, sulfate (1:1)
TL8000537
Tox21_111570
Tox21_111570_1
UNII-08I79HTP27
Y-9563
Z1550648767
Paragraph IV (Patent) Challenges for CLOPIDOGREL BISULFATE
Tradename Dosage Ingredient NDA Submissiondate
PLAVIX TABLET;ORAL clopidogrel bisulfate 020839 2009-03-04

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
Ani Pharms Inc CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 090625-001 May 17, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Sciegen Pharms Inc CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 204165-002 Sep 15, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 202925-002 Mar 27, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-001 Nov 17, 1997 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Apotex Inc CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 076274-002 Mar 4, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Torrent Pharms Ltd CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 090844-001 May 17, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
>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 clopidogrel bisulfate

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

Supplementary Protection Certificates for clopidogrel bisulfate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0281459 35/1998 Austria   Start Trial PRODUCT NAME: CLOPIDOGREL-HYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/98/069/001 - EU/1/98/069/003 19980715
0281459 9890035-0 98910359 Sweden   Start Trial PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715
0281459 9890035 Sweden   Start Trial PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715
0281459 C990002 Netherlands   Start Trial PRODUCT NAME: CLOPIDOGREL WATERSTOFSULFAAT; REGISTRATION NO/DATE: EU 1/98/069/001 - EU 1/98/069/003 19980715
0281459 98C0036 France   Start Trial 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
0302769 98C0036 Belgium   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
Dow
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Moodys

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