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NAVITRUX

NDA

FOSAPREPITANT DIMEGLUMINE | N220436 | AVYXA HOLDINGS LLC

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

15 trials from ClinicalTrials.gov, 9 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Fosaprepitant Dimeglumine in Preventing Nausea and Vomiting in Patients With Gastrointestinal Cancer Receiving Combination Chemotherapy NCT01504711	N/A	Completed	Philip Philip	30	2012-06 → 2020-09-03
Study of the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children (MK-0517-029)NCT01697579	Phase 2	Completed	Merck Sharp & Dohme LLC	240	2012-12-13 → 2016-11-21
Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031)NCT01594749	Phase 3	Completed	Merck Sharp & Dohme LLC	1,015	2012-09-24 → 2014-11-03
Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045)NCT04054193	Phase 4	Completed	Merck Sharp & Dohme LLC	103	2019-09-09 → 2021-02-11
Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)NCT00619359	Phase 3	Completed	Merck Sharp & Dohme LLC	2,322	2008-02 → 2009-06
Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin NCT01074697	Phase 3	Completed	Odense University Hospital	246	2010-04 → 2015-04
Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)NCT00337727	Phase 3	Completed	Merck Sharp & Dohme LLC	848	2007-01-01 → 2008-11-19
Fosaprepitant in Patients Receiving Ifosfamide-based Regimen NCT01490060	N/A	Completed	M.D. Anderson Cancer Center	47	2012-05 → 2016-03
Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy NCT03578081	Phase 3	Completed	Alliance for Clinical Trials in Oncology	690	2018-11-20 → 2023-05-01
Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030)NCT01405924	Phase 2	Terminated	Merck Sharp & Dohme LLC	111	2011-10-25 → 2013-12-06

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

API Supply Chain17 active DMFs2 inactive

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

HETERO DRUGS LTDFOSAPREPITANT DIMEGLUMINE

DMF 256142011

MSN LABORATORIES PRIVATE LTDFOSAPREPITANT DIMEGLUMINE [ROUTE CODE - "FD"]

DMF 256822012

LIANYUNGANG RUNZHONG PHARMACEUTICAL CO LTDFOSAPREPITANT DIMEGLUMINE, NON-STERILE BULK DRUG SUBSTANCE

DMF 282882014

ALIVUS LIFE SCIENCES LTDFOSAPREPITANT DIMEGLUMINE

DMF 289922015

WOCKHARDT BIO AGFOSAPREPITANT DIMEGLUMINE

DMF 301372015

SCINOPHARM TAIWAN LTDFOSAPREPITANT DIMEGLUMINE

DMF 309732017

APITORIA PHARMA PRIVATE LTDFOSAPREPITANT DIMEGLUMINE

DMF 314702017

PIRAMAL PHARMA LTDFOSAPREPITANT DIMEGLUMINE

DMF 314842017

NAVINTA LLCFOSAPREPITANT DIMEGLUMINE

DMF 331052018

SHANDONG ANXIN PHARMACEUTICAL CO LTDFOSAPREPITANT DIMEGLUMINE (NON-STERILE API)

DMF 331422018

VIWIT PHARMACEUTICAL CO LTDFOSAPREPITANT DIMEGLUMINE

DMF 335582019

WISDOM PHARMACEUTICAL CO LTDFOSAPREPITANT DIMEGLUMINE

DMF 357662021

GLAND PHARMA LTDFOSAPREPITANT DIMEGLUMINE

DMF 378772023

DR REDDYS LABORATORIES LTDFOSAPREPITANT DIMEGLUMINE

DMF 382102023

MAHI DRUGS PRIVATE LTDFOSAPREPITANT DIMEGLUMINE

DMF 387312023

BIOPHORE INDIA PHARMACEUTICALS PVT LTDFOSAPREPITANT DIMEGLUMINE

DMF 404682024

SHANDONG NEW TIME PHARMACEUTICAL CO LTDFOSAPREPITANT DIMEGLUMINE

DMF 423412025

DR REDDYS LABORATORIES LTDInactiveFOSAPREPITANT DIMEGLUMINE

DMF 248292011

WISDOM PHARMACEUTICAL CO LTDInactiveFOSAPREPITANT DIMEGLUMINE

DMF 336792019

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 26, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 150MG BASE/VIAL

RLD

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Jun 24, 2026

No patent or exclusivity listings for this strength.