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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 six 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. Six suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.
The generic ingredient in ISENTRESS HD 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 022145
| Tradename: | ISENTRESS HD |
| Applicant: | Merck Sharp Dohme |
| Ingredient: | raltegravir potassium |
| Patents: | 5 |
| 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 | 0006-0227-61 | 60 TABLET, FILM COATED in 1 BOTTLE (0006-0227-61) |
| ISENTRESS HD | 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) |
Paragraph IV (Patent) Challenges for 022145
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ISENTRESS HD | TABLET;ORAL | raltegravir potassium | 022145 | 2011-10-12 |
| ISENTRESS | TABLET;ORAL | raltegravir potassium | 022145 | 2011-10-12 |
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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