Last Updated: June 25, 2026

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, Alembic, Amneal, Baxter Hlthcare Corp, Caplin, Cipla, Dr Reddys, Gland, Glaxosmithkline, Intl Medication, Orbicular, Sunny, Hospira, Bausch, Agnitio, Amneal Pharms Co, Hikma, Sciegen Pharms, Sinotherapeutics Inc, and Zydus Lifesciences, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for phytonadione. Thirty 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
Salford Royal NHS Foundation TrustPhase 3
University of SydneyPhase 3
Australasian Kidney Trials NetworkPhase 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
Glaxosmithkline PHYTONADIONE phytonadione INJECTABLE;INJECTION 084060-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Intl Medication PHYTONADIONE phytonadione INJECTABLE;INJECTION 083722-001 Approved Prior to Jan 1, 1982 AB1 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira VITAMIN K1 phytonadione INJECTABLE;INJECTION 087956-001 Jul 25, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Amneal Pharms Co PHYTONADIONE phytonadione TABLET;ORAL 209373-001 May 11, 2018 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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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