Clopidogrel bisulfate - Generic Drug Details

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, Amneal Pharms, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Cadila, Celltrion, Dr Reddys, Dr Reddys Labs Ltd, Graviti Pharms, Macleods Pharms Ltd, Polygen Pharms, Prinston Inc, Rising, 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 forty-five drug master file entries for clopidogrel bisulfate. Thirty-nine suppliers are listed for this compound.

Summary for clopidogrel bisulfate

US Patents:	0
Tradenames:	2
Applicants:	22
NDAs:	23
Drug Master File Entries:	45
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	19
Patent Applications:	7,127
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
Joint Stock Company "Farmak"	Phase 1
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	N/A
The First Affiliated Hospital with Nanjing Medical University	Phase 4

See all clopidogrel bisulfate clinical trials

Pharmacology for clopidogrel bisulfate

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

Paragraph IV (Patent) Challenges for CLOPIDOGREL BISULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PLAVIX	Tablets	clopidogrel bisulfate	300 mg	020839	1	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
Aurobindo Pharma Ltd	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	090540-001	May 17, 2012	AB	RX	No	No
Rising	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	077665-002	May 17, 2012		DISCN	No	No
Cadila	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	201686-001	Oct 10, 2012		DISCN	No	No
Torrent Pharms Ltd	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	090844-001	May 17, 2012	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	020839-002	Sep 20, 2007
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-001	Nov 17, 1997