PHYTONADIONE - Generic Drug Details

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

Phytonadione is the generic ingredient in five branded drugs marketed by Pai Holdings Pharm, Roche, Cipla, Dr Reddys, Glaxosmithkline, Intl Medication, Hospira, Bausch, Agnitio, Amneal Pharms Co, Sciegen Pharms Inc, and Zydus, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for phytonadione. Sixteen suppliers are listed for this compound.

Sponsor	Phase
University of Sydney	Phase 3
Australasian Kidney Trials Network	Phase 3
Waitemata District Health Board	Phase 3

Sponsor

Phase

University of Sydney

Phase 3

Australasian Kidney Trials Network

Phase 3

Waitemata District Health Board

Phase 3

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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
Amneal Pharms Co	PHYTONADIONE	phytonadione	TABLET;ORAL	209373-001	May 11, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	VITAMIN K1	phytonadione	INJECTABLE;INJECTION	087954-001	Jul 25, 1983	BP	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cipla	PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	212424-001	Apr 22, 2022		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Roche	KONAKION	phytonadione	INJECTABLE;INJECTION	011745-003	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	084060-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cipla	PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	214596-001	Apr 22, 2022		RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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:	12
NDAs:	15
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	7
Patent Applications:	5,478
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for PHYTONADIONE
What excipients (inactive ingredients) are in PHYTONADIONE?	PHYTONADIONE excipients list
DailyMed Link:	PHYTONADIONE at DailyMed

Drug Class	Vitamin K Warfarin Reversal Agent
Physiological Effect	Increased Prothrombin Activity Reversed Anticoagulation Activity