Details for New Drug Application (NDA): 021549

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NDA 021549 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 021549

Tradename:	EMEND
Applicant:	Merck
Ingredient:	aprepitant
Patents:	1

Pharmacology for NDA: 021549

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

Suppliers and Packaging for NDA: 021549

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EMEND	aprepitant	CAPSULE;ORAL	021549	NDA	Merck Sharp & Dohme LLC	0006-0461	0006-0461-02	2 CAPSULE in 1 DOSE PACK (0006-0461-02)
EMEND	aprepitant	CAPSULE;ORAL	021549	NDA	Merck Sharp & Dohme LLC	0006-0461	0006-0461-12	2 CAPSULE in 1 DOSE PACK (0006-0461-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	80MG
Approval Date:	Mar 26, 2003	TE:	AB	RLD:	Yes
Patent:	8,258,132	Patent Expiration:	Sep 26, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	FOR THE PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH CHEMOTHERAPY
Patent:	8,258,132	Patent Expiration:	Sep 26, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	125MG
Approval Date:	Mar 26, 2003	TE:	AB	RLD:	Yes
Patent:	8,258,132	Patent Expiration:	Sep 26, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	FOR THE PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH CHEMOTHERAPY

Expired US Patents for NDA 021549

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-001	Mar 26, 2003	5,719,147	⤷ Subscribe
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-002	Mar 26, 2003	6,096,742	⤷ Subscribe
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-003	Jun 30, 2006	6,096,742	⤷ Subscribe
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-002	Mar 26, 2003	6,235,735	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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