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Generated: November 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205786

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NDA 205786 describes ISENTRESS, which is a drug marketed by Merck Sharp Dohme and is included in three NDAs. It is available from nine suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ISENTRESS profile page.

The generic ingredient in ISENTRESS is raltegravir potassium. There are five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.
Summary for 205786
Tradename:ISENTRESS
Applicant:Merck Sharp Dohme
Ingredient:raltegravir potassium
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 205786
Mechanism of ActionHIV Integrase Inhibitors
Medical Subject Heading (MeSH) Categories for 205786
Suppliers and Packaging for NDA: 205786
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISENTRESS raltegravir potassium POWDER;ORAL 205786 NDA Merck Sharp & Dohme Corp. 0006-3603 0006-3603-60 60 PACKET in 1 CARTON (0006-3603-60) > 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01)
ISENTRESS raltegravir potassium POWDER;ORAL 205786 NDA Merck Sharp & Dohme Corp. 0006-3603 0006-3603-61 60 PACKET in 1 CARTON (0006-3603-61) > 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrengthEQ 100MG BASE/PACKET
Approval Date:Dec 20, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 22, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:May 22, 2021
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:➤ Sign UpPatent Expiration:Apr 3, 2024Product Flag?Substance Flag?Delist Request?Y

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