CLOPIDOGREL BISULFATE - Generic Drug Details

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What are the generic drug 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, Alkem Labs Ltd, Amneal Pharms, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, Polygen Pharms, Prinston Inc, Rising, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva, Torrent Pharms Ltd, Zydus Lifesciences, and Sanofi Aventis Us, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-five drug master file entries for clopidogrel bisulfate. Forty-two suppliers are listed for this compound.

Summary for CLOPIDOGREL BISULFATE

US Patents:	0
Tradenames:	2
Applicants:	23
NDAs:	25
Drug Master File Entries:	45
Finished Product Suppliers / Packagers:	42
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	19
Patent Applications:	7,388
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

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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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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

Anatomical Therapeutic Chemical (ATC) Classes for CLOPIDOGREL BISULFATE

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	076273-001	Jan 14, 2008	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
Zydus Lifesciences	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	201686-001	Oct 10, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Prinston Inc	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	206376-002	May 7, 2018	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

Expired US Patents for CLOPIDOGREL BISULFATE

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

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