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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
US Army
US Department of Justice
Express Scripts

Generated: September 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022145

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NDA 022145 describes ISENTRESS HD, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from ten suppliers. There are five patents protecting this drug. Additional details are available on the ISENTRESS HD profile page.

The generic ingredient in ISENTRESS HD is raltegravir potassium. There are five drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.

Summary for NDA: 022145

Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 022145

Mechanism of ActionHIV Integrase Inhibitors

Suppliers and Packaging for NDA: 022145

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
raltegravir potassium
TABLET;ORAL 022145 NDA Merck Sharp & Dohme Corp. 0006-0227 0006-0227-61 60 TABLET, FILM COATED in 1 BOTTLE (0006-0227-61)
raltegravir potassium
TABLET;ORAL 022145 NDA Merck Sharp & Dohme Corp. 0006-3080 0006-3080-01 60 TABLET, FILM COATED in 1 BOTTLE (0006-3080-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Oct 12, 2007TE:RLD:Yes
Regulatory Exclusivity Expiration:May 26, 2020
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Nov 26, 2020
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:► SubscribePatent Expiration:Apr 3, 2024Product Flag?Substance Flag?Delist Request?Y

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Serving 500+ biopharmaceutical companies globally:

Argus Health
US Army
Daiichi Sankyo
US Department of Justice
Cantor Fitzgerald
Harvard Business School

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.

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