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Last Updated: August 11, 2020

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PHYTONADIONE Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Phytonadione

A generic version of PHYTONADIONE was approved as phytonadione by AMNEAL PHARMS CO on May 11th, 2018.

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Drug patent expirations by year for PHYTONADIONE
Drug Prices for PHYTONADIONE

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Recent Clinical Trials for PHYTONADIONE

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

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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
Dr Reddys Labs Ltd PHYTONADIONE phytonadione INJECTABLE;INJECTION 207719-001 May 22, 2019 AB RX 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
Glaxosmithkline PHYTONADIONE phytonadione INJECTABLE;INJECTION 084060-001 Approved Prior to Jan 1, 1982 DISCN 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
Zydus PHYTONADIONE phytonadione TABLET;ORAL 210189-001 Feb 20, 2019 AB RX 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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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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Mallinckrodt

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