Details for New Drug Application (NDA): 205786
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NDA 205786 describes ISENTRESS, which is a drug marketed by Msd Sub Merck and is included in three NDAs. It is available from nine suppliers. There are six 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. Nine 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. Nine suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.
Summary for 205786
| Tradename: | ISENTRESS |
| Applicant: | Msd Sub Merck |
| Ingredient: | raltegravir potassium |
| Patents: | 4 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205786
Generic Entry Date for 205786*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;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: 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 LLC | 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 LLC | 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 | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 3, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 21, 2023 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 21, 2023 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 205786
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Msd Sub Merck | ISENTRESS | raltegravir potassium | POWDER;ORAL | 205786-001 | Dec 20, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | ISENTRESS | raltegravir potassium | POWDER;ORAL | 205786-001 | Dec 20, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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