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 Lifesciences, 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. Seventeen suppliers are listed for this compound.

Summary for PHYTONADIONE

US Patents:	0
Tradenames:	5
Applicants:	12
NDAs:	15
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	7
Patent Applications:	5,478
Drug Prices:	Drug price trends for PHYTONADIONE
What excipients (inactive ingredients) are in PHYTONADIONE?	PHYTONADIONE excipients list
DailyMed Link:	PHYTONADIONE at DailyMed

See drug prices for PHYTONADIONE

Recent Clinical Trials for PHYTONADIONE

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

Sponsor	Phase
Waitemata District Health Board	Phase 3
Salford Royal NHS Foundation Trust	Phase 3
University of Sydney	Phase 3

See all PHYTONADIONE clinical trials

Pharmacology for PHYTONADIONE

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

US Patents and Regulatory Information for PHYTONADIONE

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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
Agnitio	PHYTONADIONE	phytonadione	TABLET;ORAL	213336-001	Oct 12, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cipla	PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	214596-001	Apr 22, 2022		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pai Holdings Pharm	AQUAMEPHYTON	phytonadione	INJECTABLE;INJECTION	012223-001	Approved Prior to Jan 1, 1982		DISCN	Yes	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

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