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Last Updated: October 20, 2021

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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 seven suppliers. There are six 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. Seven suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.
Summary for 203045
Applicant:Merck Sharp Dohme
Ingredient:raltegravir potassium
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 203045
Generic Entry Date for 203045*:
Constraining patent/regulatory exclusivity:

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 0006-0473-61 60 TABLET, CHEWABLE in 1 BOTTLE (0006-0473-61)
ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045 NDA Merck Sharp & Dohme Corp. 0006-0477 0006-0477-61 60 TABLET, CHEWABLE in 1 BOTTLE (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:May 22, 2021
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:⤷  Free Forever TrialPatent Expiration:Apr 3, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Free Forever TrialPatent Expiration:Apr 21, 2023Product Flag?Substance Flag?Delist Request?Y

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim

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