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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 patent protection?

Clopidogrel bisulfate is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Acme Labs, Actavis Totowa, Adaptis, Amneal Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Cadila, Celltrion, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Polygen Pharms, Prinston Inc, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva, Torrent Pharms Ltd, and Sanofi Aventis Us, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for clopidogrel bisulfate

US Patents:	0
Tradenames:	2
Applicants:	22
NDAs:	23
Drug Master File Entries:	54
Suppliers / Packagers:	43
Bulk Api Vendors:	109
Clinical Trials:	16
Patent Applications:	4,152
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for clopidogrel bisulfate
Drug Sales Revenues:	Drug sales revenues for clopidogrel bisulfate
What excipients (inactive ingredients) are in clopidogrel bisulfate?	clopidogrel bisulfate excipients list
DailyMed Link:	clopidogrel bisulfate at DailyMed

See drug prices for clopidogrel bisulfate

See drug sales revenues for clopidogrel bisulfate

Recent Clinical Trials for clopidogrel bisulfate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	N/A
The First Affiliated Hospital with Nanjing Medical University	Phase 4
CKD Pharmaceutical Limited	Phase 4

See all clopidogrel bisulfate clinical trials

Pharmacology for clopidogrel bisulfate

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

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
Torrent Pharms Ltd	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	090844-001	May 17, 2012	AB	RX	No	No
Aurobindo Pharma Ltd	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	090540-001	May 17, 2012	AB	RX	No	No
Amneal Pharms	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	203751-001	Apr 11, 2014	AB	RX	No	No
Adaptis	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	204359-001	Feb 2, 2017	AB	RX	No	No
Ani Pharms Inc	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	090625-001	May 17, 2012		DISCN	No	No
Macleods Pharms Ltd	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	202928-001	Feb 10, 2014	AB	RX	No	No

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