Details for New Drug Application (NDA): 209935
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NDA 209935 describes KISQALI FEMARA CO-PACK (COPACKAGED), which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the KISQALI FEMARA CO-PACK (COPACKAGED) profile page.
The generic ingredient in KISQALI FEMARA CO-PACK (COPACKAGED) 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 FEMARA CO-PACK (COPACKAGED) 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 209935
| Tradename: | KISQALI FEMARA CO-PACK (COPACKAGED) |
| Applicant: | Novartis |
| Ingredient: | letrozole; ribociclib succinate |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209935
*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.
Suppliers and Packaging for NDA: 209935
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole; ribociclib succinate | TABLET;ORAL | 209935 | NDA | Novartis Pharmaceuticals Corporation | 0078-0909 | 0078-0909-61 | 1 KIT in 1 KIT (0078-0909-61) * 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50) * 21 TABLET in 1 BLISTER PACK (0078-0888-21) |
| KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole; ribociclib succinate | TABLET;ORAL | 209935 | NDA | Novartis Pharmaceuticals Corporation | 0078-0916 | 0078-0916-61 | 1 KIT in 1 KIT (0078-0916-61) * 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50) * 14 TABLET in 1 BLISTER PACK (0078-0895-14) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG;EQ 200MG BASE | ||||
| Approval Date: | May 4, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 17, 2027 | ||||||||
| Regulatory Exclusivity Use: | 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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