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Last Updated: July 8, 2020

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 one supplier. There is one patent 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 eleven drug master file entries for this compound. Thirteen suppliers are 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:0
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. 0006-3061 0006-3061-04 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-3061-04) > 5 mL in 1 VIAL, SINGLE-DOSE (0006-3061-01)
Paragraph IV (Patent) Challenges for 022023
Tradename Dosage Ingredient NDA Submissiondate
EMEND POWDER;INTRAVENOUS fosaprepitant dimeglumine 022023 2012-01-25

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115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 150MG BASE/VIAL
Approval Date:Nov 12, 2010TE:APRLD:Yes
Regulatory Exclusivity Expiration:Apr 3, 2021
Regulatory Exclusivity Use:NEW PATIENT POPULATION

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

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