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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 six 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. Six suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.

Summary for NDA: 205786

Merck Sharp Dohme
raltegravir potassium
Therapeutic Class:Antivirals

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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.