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Generated: April 29, 2017

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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 four 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 NDA: 205786

Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 205786

Mechanism of ActionHIV Integrase Inhibitors

Suppliers and Packaging for NDA: 205786

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrengthEQ 100MG BASE/PACKET
Approval Date:Dec 20, 2013TE:RLD:Yes
Patent:7,169,780Patent Expiration:Oct 3, 2023Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Dec 20, 2016
Regulatory Exclusivity Use:NEW DOSAGE FORM
Patent:7,217,713Patent Expiration:Oct 21, 2022Product Flag?Substance Flag?Delist Request?

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