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Generated: November 18, 2018

DrugPatentWatch Database Preview

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 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 021549
Tradename:EMEND
Applicant:Merck
Ingredient:aprepitant
Patents:2
Formulation / Manufacturing:see details
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 Corp. 0006-0461 0006-0461-02 2 CAPSULE in 1 DOSE PACK (0006-0461-02)
EMEND aprepitant CAPSULE;ORAL 021549 NDA Merck Sharp & Dohme Corp. 0006-0461 0006-0461-06 1 BLISTER PACK in 1 CARTON (0006-0461-06) > 6 CAPSULE in 1 BLISTER PACK (0006-0461-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength80MG
Approval Date:Mar 26, 2003TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Aug 28, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:➤ Sign UpPatent Expiration:Jul 1, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jul 1, 2018Product Flag?YSubstance Flag?YDelist Request?

Expired US Patents for NDA 021549

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck EMEND aprepitant CAPSULE;ORAL 021549-003 Jun 30, 2006 ➤ Sign Up ➤ Sign Up
Merck EMEND aprepitant CAPSULE;ORAL 021549-001 Mar 26, 2003 ➤ Sign Up ➤ Sign Up
Merck EMEND aprepitant CAPSULE;ORAL 021549-001 Mar 26, 2003 ➤ Sign Up ➤ Sign Up
Merck EMEND aprepitant CAPSULE;ORAL 021549-001 Mar 26, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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