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Generated: November 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022023

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NDA 022023 describes EMEND, which is a drug marketed by Merck, Msd Merck Co, and Merck And Co Inc, and is included in three NDAs. It is available from two suppliers. There are three patents protecting this drug and four Paragraph IV challenges. Additional details are available on the EMEND profile page.

The generic ingredient in EMEND is fosaprepitant dimeglumine. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.
Summary for 022023
Tradename:EMEND
Applicant:Merck And Co Inc
Ingredient:fosaprepitant dimeglumine
Patents:1
Suppliers and Packaging for NDA: 022023
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMEND fosaprepitant dimeglumine POWDER;INTRAVENOUS 022023 NDA Merck Sharp & Dohme Corp. 0006-3061 0006-3061-00 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-3061-00) > 5 mL in 1 VIAL, SINGLE-DOSE (0006-3061-01)
EMEND fosaprepitant dimeglumine POWDER;INTRAVENOUS 022023 NDA Merck Sharp & Dohme Corp. 0006-3941 0006-3941-32 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-3941-32) > 5 mL in 1 VIAL, SINGLE-DOSE (0006-3941-01)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;INTRAVENOUSStrengthEQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jan 25, 2008TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 3, 2021
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Oct 3, 2021
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:➤ Try a Free TrialPatent Expiration:Sep 4, 2019Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022023

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck And Co Inc EMEND fosaprepitant dimeglumine POWDER;INTRAVENOUS 022023-002 Nov 12, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Merck And Co Inc EMEND fosaprepitant dimeglumine POWDER;INTRAVENOUS 022023-002 Nov 12, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Merck And Co Inc EMEND fosaprepitant dimeglumine POWDER;INTRAVENOUS 022023-001 Jan 25, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Merck And Co Inc EMEND fosaprepitant dimeglumine POWDER;INTRAVENOUS 022023-001 Jan 25, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Merck And Co Inc EMEND fosaprepitant dimeglumine POWDER;INTRAVENOUS 022023-001 Jan 25, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Covington
Express Scripts
Johnson and Johnson
Argus Health
QuintilesIMS
Merck
Cantor Fitzgerald
Fuji

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