DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 022145
The generic ingredient in ISENTRESS HD is raltegravir potassium. There are five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.
Summary for 022145
Tradename: | ISENTRESS HD |
Applicant: | Merck Sharp Dohme |
Ingredient: | raltegravir potassium |
Patents: | 5 |
Therapeutic Class: | Antivirals |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022145
Mechanism of Action | HIV Integrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 022145
Suppliers and Packaging for NDA: 022145
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISENTRESS | raltegravir potassium | TABLET;ORAL | 022145 | NDA | Merck Sharp & Dohme Corp. | 0006-0227 | N | 0006-0227-61 |
ISENTRESS | raltegravir potassium | TABLET;ORAL | 022145 | NDA | Merck Sharp & Dohme Corp. | 0006-3080 | N | 0006-3080-01 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 400MG BASE | ||||
Approval Date: | Oct 12, 2007 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | May 26, 2020 | ||||||||
Regulatory Exclusivity Use: | ADDITION OF 1200 MG ONCE DAILY DOSING FOR TREATMENT-NAIVE PATIENTS OR PATIENTS WHO ARE VIROLOGICALLY SUPPRESSED ON AN INITIAL REGIMEN OF RALTEGRAVIR FILM-COATED TABLETS 400 MG TWICE DAILY | ||||||||
Regulatory Exclusivity Expiration: | Nov 22, 2020 | ||||||||
Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Regulatory Exclusivity Expiration: | May 22, 2021 | ||||||||
Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY |
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