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Last Updated: November 2, 2024

Phytonadione - Generic Drug Details


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What are the generic drug sources for phytonadione and what is the scope of patent protection?

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
Drug Prices for phytonadione

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Recent Clinical Trials for phytonadione

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

SponsorPhase
University of SydneyPhase 3
Australasian Kidney Trials NetworkPhase 3
Waitemata District Health BoardPhase 3

See all phytonadione clinical trials

Pharmacology for phytonadione

US Patents and Regulatory Information for phytonadione

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira VITAMIN K1 phytonadione INJECTABLE;INJECTION 087955-001 Jul 25, 1983 AB1 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch MEPHYTON phytonadione TABLET;ORAL 010104-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys PHYTONADIONE phytonadione INJECTABLE;INJECTION 207719-001 May 22, 2019 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline PHYTONADIONE phytonadione INJECTABLE;INJECTION 084060-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira VITAMIN K1 phytonadione INJECTABLE;INJECTION 087954-001 Jul 25, 1983 BP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cipla PHYTONADIONE phytonadione INJECTABLE;INJECTION 214596-002 Apr 22, 2022 RX No Yes ⤷  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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