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Last Updated: August 11, 2020

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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 Teligent, Roche, Dr Reddys Labs Ltd, Glaxosmithkline, Intl Medication, Hospira, Bausch, Amneal Pharms Co, and Zydus, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for phytonadione

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Recent Clinical Trials for phytonadione

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

Wayne State UniversityEarly Phase 1
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all phytonadione clinical trials

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
Amneal Pharms Co PHYTONADIONE phytonadione TABLET;ORAL 209373-001 May 11, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Hospira VITAMIN K1 phytonadione INJECTABLE;INJECTION 087954-001 Jul 25, 1983 BP RX No Yes   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd PHYTONADIONE phytonadione INJECTABLE;INJECTION 207719-001 May 22, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline PHYTONADIONE phytonadione INJECTABLE;INJECTION 084060-002 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 BP RX No Yes   Start Trial   Start Trial   Start Trial
Zydus PHYTONADIONE phytonadione TABLET;ORAL 210189-001 Feb 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Bausch MEPHYTON phytonadione TABLET;ORAL 010104-003 Approved Prior to Jan 1, 1982 AB RX Yes Yes   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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Serving leading biopharmaceutical companies globally:

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