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Farmers Insurance
Fuji
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Boehringer Ingelheim
Covington
Healthtrust
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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203045

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NDA 203045 describes ISENTRESS, which is a drug marketed by Merck Sharp Dohme and is included in three NDAs. It is available from eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.
Summary for 203045
Tradename:ISENTRESS
Applicant:Merck Sharp Dohme
Ingredient:raltegravir potassium
Patents:4
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 203045
Mechanism of ActionHIV Integrase Inhibitors
Medical Subject Heading (MeSH) Categories for 203045
Suppliers and Packaging for NDA: 203045
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045 NDA Merck Sharp & Dohme Corp. 0006-0473 N 0006-0473-61
ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045 NDA Merck Sharp & Dohme Corp. 0006-0477 N 0006-0477-61

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 25MG BASE
Approval Date:Dec 21, 2011TE: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:➤ Try a Free TrialPatent Expiration:Apr 3, 2024Product Flag?Substance Flag?Delist Request?Y

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Federal Trade Commission
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Chinese Patent Office
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Dow
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