Details for New Drug Application (NDA): 209092
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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: | ⤷ Sign Up | Patent Expiration: | Apr 14, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? |
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