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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207865

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NDA 207865 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 207865
Applicant:Msd Merck Co
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 207865
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMEND aprepitant FOR SUSPENSION;ORAL 207865 NDA Merck Sharp & Dohme Corp. 0006-3066 0006-3066-03 1 POUCH in 1 CARTON (0006-3066-03) > 1 POWDER, FOR SUSPENSION in 1 POUCH (0006-3066-01)
Paragraph IV (Patent) Challenges for 207865
Tradename Dosage Ingredient NDA Submissiondate
EMEND FOR SUSPENSION;ORAL aprepitant 207865 2016-11-23

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/KIT
Approval Date:Dec 17, 2015TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Sep 26, 2027Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Express Scripts
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