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. Twenty-three 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

Pharmacology for NDA: 022023

Mechanism of Action	Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors Neurokinin 1 Antagonists

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 LLC	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)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 25, 2008	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	May 2, 2025
Regulatory Exclusivity Use:	ADDITION OF A 3-DAY FOSAPREPITANT FOR INJECTION INTRAVENOUS DOSING REGIMEN IN PEDIATRIC PATIENTS FOR THE CURRENTLY APPROVED PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 150MG BASE/VIAL
Approval Date:	Nov 12, 2010	TE:	AP	RLD:	Yes
Regulatory Exclusivity Expiration:	May 2, 2025
Regulatory Exclusivity Use:	ADDITION OF A 3-DAY FOSAPREPITANT FOR INJECTION INTRAVENOUS DOSING REGIMEN IN PEDIATRIC PATIENTS FOR THE CURRENTLY APPROVED PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING

Expired US Patents for NDA 022023

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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	7,214,692	⤷ Subscribe
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008	7,214,692	⤷ Subscribe
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-002	Nov 12, 2010	5,716,942	⤷ Subscribe
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008	5,512,570	⤷ Subscribe
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