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MEPHYTON

NDA

PHYTONADIONE | N010104 | BAUSCH HEALTH AMERICAS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lachman Consultant Services, Inc. FDA-2023-P-4596 · 5 docket documents Lachman Consultant Services, Inc. filed this citizen petition requesting that the FDA determine whether the Reference Listed Drug MEPHYTON (phytonadione) Tablets, 5 mg, NDA 010104, held by Bausch Health Americas Inc., was voluntarily withdrawn from sale for safety or efficacy reasons. The petitioner	505(q)	2023-10-18	Granted	Lachman Consultant Services, Inc.
Citizen Petition from Axinn on behalf of Zydus Pharmaceuticals (USA) Inc. FDA-2019-P-2240 · 10 docket documents Axinn, on behalf of Zydus Pharmaceuticals (USA) Inc., filed this citizen petition pursuant to Section 505 of the Federal Food, Drug and Cosmetic Act requesting that the FDA require manufacturers of Phytonadione Tablets ANDAs referencing Mephyton (NDA No. 010104) to provide data demonstrating compara	505(q)	2019-05-09	Partially Denied	Zydus Pharmaceuticals (USA) Inc.
Hyman, Phelps & McNamara, P.C. - Citizen Petition FDA-2011-P-0226 · 4 docket documents Hyman, Phelps & McNamara, P.C., on behalf of a client, filed this petition requesting that the FDA designate International Medication Systems' Phytonadione Injection, 1MG/0.5ML (ANDA No. 83-722) as a second Reference Listed Drug in the Orange Book, to enable generic competition against this product	Other	2011-04-05	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

6 trials from ClinicalTrials.gov, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients NCT01528800	Phase 2	Completed	Dr. Rachel Holden	85	2012-11 → 2019-12
Vitamin K Supplementation in Patients on Hemodialysis NCT02324686	Phase 2	Completed	University Health Network, Toronto	3	2014-01 → 2017-12-18
Oral Vitamin K for Warfarin Associated Coagulopathy NCT00143715	Phase 3	Completed	St. Joseph's Healthcare Hamilton	690	2004-09 → 2007-01
Does Low Dose Oral Vitamin K Improve International Normalized Ratio (INR) Stability?NCT00990158	Phase 3	Completed	St. Joseph's Healthcare Hamilton	235	2010-07 → 2014-04
Use of Phytonadione to Reduce International Normalized Ratio (INR) Variability in Patients on Long-term Warfarin Therapy NCT01474460	N/A	Completed	James A. Haley Veterans Administration Hospital	370	2011-09 → 2015-11
Comparing Different Routes and Doses of Phytonadione (Vitamin K) for Reversing Warfarin Treated Patients With Hip Fracture Before Surgery NCT00905229	N/A	Withdrawn	HaEmek Medical Center, Israel	—	2009-05 → 2010-04

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain11 active DMFs1 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPHYTONADIONE

DMF 264472012

G AND A ASSOC INCPHYTONADIONE USP, NON STERILE, BULK DRUG

DMF 266542012

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPHYTONADIONE ROUTE-B

DMF 278052013

MSN LABORATORIES PRIVATE LTDPHYTONADIONE USP [ROUTE CODE "HN"]

DMF 296692015

ENALTEC LABS PRIVATE LTDPHYTONADIONE USP

DMF 301762016

EMCURE PHARMACEUTICALS LTDPHYTONADIONE USP

DMF 307752016

NAVINTA LLCPHYTONADIONE USP (PROCESS A)

DMF 309102016

ENALTEC LABS PRIVATE LTDPHYTONADIONE USP

DMF 329472018

SUNNY PHARMTECH INCPHYTONADIONE, USP

DMF 340542019

AMPHASTAR NANJING PHARMACEUTICALS INCPHYTONADIONE USP

DMF 379532023

ANHUI WANHE PHARMACEUTICAL CO LTDPHYTONADIONE (VITAMIN K1)

DMF 428962025

NISSHIN PHARMA INCInactivePHYTONADIONE, USP (VITAMIN K1)

DMF 35311979

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jul 20, 2021	SUPPL -31	View Letter (PDF)
Jan 26, 2010	SUPPL -28	View Letter (PDF)
Mar 2, 2004	SUPPL -22	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#003 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.