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Details for Generic Name: fosaprepitant dimeglumine

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Fosaprepitant dimeglumine is the generic ingredient in one branded drug marketed by Merck And Co Inc and is included in one NDA. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-six patent family members in twenty-seven countries.

There are five drug master file entries for fosaprepitant dimeglumine. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: fosaprepitant dimeglumine

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: see list5
Suppliers / Packaging: see list2

Tentative approvals for FOSAPREPITANT DIMEGLUMINE

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE;INJECTION150MG

Clinical Trials for: fosaprepitant dimeglumine

A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)
Status: Terminated Condition: Chemotherapy-Induced Nausea and Vomiting

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)
Status: Recruiting Condition: Chemotherapy-induced Nausea and Vomiting

Efficacy of Aprepitant (Emend®) in Children
Status: Recruiting Condition: Nausea; Vomiting; Childhood Cancer

Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Lymphoma Patients
Status: Completed Condition: Lymphoma

Topical Aprepitant in Prurigo Patients
Status: Completed Condition: Pruritus

Aprepitant and Fosaprepitant Time-on-Target PET (Positron Emission Tomography) Study (0869-183)
Status: Completed Condition: Chemotherapy-Induced Nausea and Vomiting (CINV)

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-002Nov 12, 2010RXYes5,691,336<disabled>YY <disabled>
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-002Nov 12, 2010RXYes5,716,942<disabled> <disabled>
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-001Jan 25, 2008DISCNNo5,691,336<disabled>YY <disabled>
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Expired Orange Book Patents for Generic Ingredient: fosaprepitant dimeglumine

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-001Jan 25, 20085,512,570<disabled>
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-002Nov 12, 20105,716,942<disabled>
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-002Nov 12, 20107,214,692<disabled>
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Non-Orange Book Patents for Generic Ingredient: fosaprepitant dimeglumine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,512,570 Treatment of emesis with morpholine tachykinin receptor antagonists<disabled in preview>
5,780,467 Morpholine compounds are prodrugs useful as tachykinin receptor antagonists<disabled in preview>
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International Patent Family for Ingredient: fosaprepitant dimeglumine

Country Document Number Publication Date
Latvia11688Jun 20, 1997
European Patent Office0748320Dec 18, 1996
HungaryT76324Aug 28, 1997
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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