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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 clopidogrel bisulfate freedom to operate?

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.

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

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

Summary for clopidogrel bisulfate

International Patents:	55
US Patents:	2
Tradenames:	2
Applicants:	22
NDAs:	22
Drug Master File Entries:	53
Suppliers / Packagers:	56
Bulk Api Vendors:	97
Clinical Trials:	15
Patent Applications:	3,559
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for clopidogrel bisulfate
DailyMed Link:	clopidogrel bisulfate at DailyMed

Pharmacology for clopidogrel bisulfate

Drug Class	P2Y12 Platelet Inhibitor
Mechanism of Action	P2Y12 Receptor Antagonists Cytochrome P450 2C8 Inhibitors
Physiological Effect	Decreased Platelet Aggregation

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
Mylan Pharms Inc	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	077665-002	May 17, 2012	AB	RX	No	No
Gate Pharms	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	091216-001	May 17, 2012	AB	RX	No	No
Sun Pharm Industries	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	078133-001	Jun 10, 2013	AB	RX	No	No
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-002	Sep 20, 2007	AB	RX	Yes	Yes					Y

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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
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-001	Nov 17, 1997
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-002	Sep 20, 2007
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-001	Nov 17, 1997

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International Patents for clopidogrel bisulfate

Country	Document Number	Estimated Expiration
Israel	139790
Japan	3641584
Slovenia	1087976
Hungary	225871

Supplementary Protection Certificates for clopidogrel bisulfate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0036	France		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
C0036	Belgium		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		PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715
8C0045	Belgium		PRODUCT NAME: CLOPIDOGREL; REGISTRATION NO/DATE: EU/1/98/069/001 19980715