Details for New Drug Application (NDA): 203045
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NDA 203045 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 203045
| Tradename: | ISENTRESS |
| Applicant: | Msd Sub Merck |
| Ingredient: | raltegravir potassium |
| Patents: | 3 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203045
Generic Entry Date for 203045*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, CHEWABLE;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: 203045
| Mechanism of Action | HIV Integrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 203045
Suppliers and Packaging for NDA: 203045
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ISENTRESS | raltegravir potassium | TABLET, CHEWABLE;ORAL | 203045 | NDA | Merck Sharp & Dohme LLC | 0006-0473 | 0006-0473-61 | 60 TABLET, CHEWABLE in 1 BOTTLE (0006-0473-61) |
| ISENTRESS | raltegravir potassium | TABLET, CHEWABLE;ORAL | 203045 | NDA | Merck Sharp & Dohme LLC | 0006-0477 | 0006-0477-61 | 60 TABLET, CHEWABLE in 1 BOTTLE (0006-0477-61) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Dec 21, 2011 | 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 | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Dec 21, 2011 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 3, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
Expired US Patents for NDA 203045
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Msd Sub Merck | ISENTRESS | raltegravir potassium | TABLET, CHEWABLE;ORAL | 203045-001 | Dec 21, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | ISENTRESS | raltegravir potassium | TABLET, CHEWABLE;ORAL | 203045-001 | Dec 21, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | ISENTRESS | raltegravir potassium | TABLET, CHEWABLE;ORAL | 203045-002 | Dec 21, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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