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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 five 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.
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 205786
| Tradename: | ISENTRESS |
| Applicant: | Merck Sharp Dohme |
| Ingredient: | raltegravir potassium |
| Patents: | 4 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205786
| Mechanism of Action | HIV Integrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 205786
Suppliers and Packaging for NDA: 205786
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ISENTRESS | 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) |
| ISENTRESS | raltegravir potassium | POWDER;ORAL | 205786 | NDA | Merck Sharp & Dohme Corp. | 0006-3603 | 0006-3603-61 | 60 PACKET in 1 CARTON (0006-3603-61) > 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | EQ 100MG BASE/PACKET | ||||
| Approval Date: | Dec 20, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 22, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | May 22, 2021 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | Start Trial | Patent Expiration: | Apr 3, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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