Details for New Drug Application (NDA): 209092
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NDA 209092 describes KISQALI, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the KISQALI profile page.
The generic ingredient in KISQALI is letrozole; ribociclib succinate. There are twenty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the letrozole; ribociclib succinate profile page.
The generic ingredient in KISQALI is letrozole; ribociclib succinate. There are twenty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the letrozole; ribociclib succinate profile page.
Summary for 209092
| Tradename: | KISQALI |
| Applicant: | Novartis |
| Ingredient: | ribociclib succinate |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209092
Generic Entry Date for 209092*:
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: 209092
| Mechanism of Action | Cytochrome P450 3A Inhibitors Kinase Inhibitors |
Suppliers and Packaging for NDA: 209092
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KISQALI | ribociclib succinate | TABLET;ORAL | 209092 | NDA | Novartis Pharmaceuticals Corporation | 0078-0860 | 0078-0860-01 | 1 BLISTER PACK in 1 CARTON (0078-0860-01) / 21 TABLET, FILM COATED in 1 BLISTER PACK |
| KISQALI | ribociclib succinate | TABLET;ORAL | 209092 | NDA | Novartis Pharmaceuticals Corporation | 0078-0867 | 0078-0867-42 | 3 BLISTER PACK in 1 CARTON (0078-0867-42) / 14 TABLET, FILM COATED in 1 BLISTER PACK (0078-0867-14) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Mar 13, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 17, 2027 | ||||||||
| Regulatory Exclusivity Use: | IN COMBINATION WITH AN AROMATASE INHIBITOR FOR THE ADJUVANT TREATMENT OF ADULTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE STAGE II AND III EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE | ||||||||
| Regulatory Exclusivity Expiration: | Dec 10, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Apr 14, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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