Warfarin sodium - Generic Drug Details

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What are the generic drug sources for warfarin sodium and what is the scope of freedom to operate?

Warfarin sodium is the generic ingredient in five branded drugs marketed by Bristol Myers Squibb, Pharm Res Assoc, Upsher Smith Labs, Abbott, Amneal Pharms, Aurobindo Pharma Usa, Barr, Chartwell Rx, Invagen Pharms, Ipca Labs Ltd, Pliva, Taro, Usl Pharma, Watson Labs, and Zydus Pharms Usa, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for warfarin sodium. Twenty-five suppliers are listed for this compound.

Sponsor	Phase
Amgen	Early Phase 1
Boehringer Ingelheim	N/A
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 1

Sponsor

Phase

Amgen

Early Phase 1

Boehringer Ingelheim

N/A

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Phase 1

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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
Bristol Myers Squibb	COUMADIN	warfarin sodium	TABLET;ORAL	009218-025	Nov 18, 1996		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ipca Labs Ltd	WARFARIN SODIUM	warfarin sodium	TABLET;ORAL	200104-002	Jun 27, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Usa	WARFARIN SODIUM	warfarin sodium	TABLET;ORAL	040415-005	Sep 27, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pliva	WARFARIN SODIUM	warfarin sodium	TABLET;ORAL	040616-006	Jul 5, 2006	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Usa	WARFARIN SODIUM	warfarin sodium	TABLET;ORAL	040415-004	Sep 27, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Barr	WARFARIN SODIUM	warfarin sodium	TABLET;ORAL	040145-009	Nov 5, 1998		DISCN	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

US Patents:	0
Tradenames:	5
Applicants:	15
NDAs:	21
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	38
Patent Applications:	6,575
Drug Prices:	Drug price trends for warfarin sodium
Drug Sales Revenues:	Drug sales revenues for warfarin sodium
What excipients (inactive ingredients) are in warfarin sodium?	warfarin sodium excipients list
DailyMed Link:	warfarin sodium at DailyMed

Drug Class	Vitamin K Antagonist
Mechanism of Action	Vitamin K Inhibitors