Details for New Drug Application (NDA): 022145
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NDA 022145 describes ISENTRESS HD, which is a drug marketed by Msd Sub Merck and is included in one NDA. It is available from nine 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. Nine 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. Nine suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.
Summary for 022145
| Tradename: | ISENTRESS HD |
| Applicant: | Msd Sub Merck |
| Ingredient: | raltegravir potassium |
| Patents: | 6 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022145
Generic Entry Date for 022145*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 LLC | 0006-0227 | 0006-0227-61 | 60 TABLET, FILM COATED in 1 BOTTLE (0006-0227-61) |
| ISENTRESS | raltegravir potassium | TABLET;ORAL | 022145 | NDA | Merck Sharp & Dohme LLC | 0006-3080 | 0006-3080-01 | 60 TABLET, FILM COATED in 1 BOTTLE (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 | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 3, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 11, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 2, 2030 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF HIV INFECTION | ||||||||
Expired US Patents for NDA 022145
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Msd Sub Merck | ISENTRESS | raltegravir potassium | TABLET;ORAL | 022145-001 | Oct 12, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | ISENTRESS | raltegravir potassium | TABLET;ORAL | 022145-001 | Oct 12, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | ISENTRESS | raltegravir potassium | TABLET;ORAL | 022145-001 | Oct 12, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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