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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 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: 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

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 25MG BASE
Approval Date:Dec 21, 2011TE:RLD:No
Patent:7,169,780Patent Expiration:Oct 3, 2023Product Flag?YSubstance Flag?YDelist Request?
Patent:7,217,713Patent Expiration:Oct 21, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HIV INFECTION
Patent:7,435,734Patent Expiration:Oct 21, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HIV INFECTION


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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.

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