Details for New Drug Application (NDA): 215358
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NDA 215358 describes SCEMBLIX, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the SCEMBLIX profile page.
The generic ingredient in SCEMBLIX is asciminib hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the asciminib hydrochloride profile page.
The generic ingredient in SCEMBLIX is asciminib hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the asciminib hydrochloride profile page.
Summary for 215358
| Tradename: | SCEMBLIX |
| Applicant: | Novartis |
| Ingredient: | asciminib hydrochloride |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215358
Generic Entry Date for 215358*:
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.
Suppliers and Packaging for NDA: 215358
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SCEMBLIX | asciminib hydrochloride | TABLET;ORAL | 215358 | NDA | Novartis Pharmaceuticals Corporation | 0078-1091 | 0078-1091-20 | 60 TABLET, FILM COATED in 1 BOTTLE (0078-1091-20) |
| SCEMBLIX | asciminib hydrochloride | TABLET;ORAL | 215358 | NDA | Novartis Pharmaceuticals Corporation | 0078-1091 | 0078-1091-94 | 14 TABLET, FILM COATED in 1 BOTTLE (0078-1091-94) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Oct 29, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 2, 2028 | ||||||||
| Regulatory Exclusivity Use: | MODIFICATIONS TO LABELING TO INCLUDE UPDATED RECOMMENDATIONS FOR CYP3A4 INDUCERS AND SUBSTRATES OF BCRP AND UPDATED DATA FOR STRONG CYP3A4 INDUCERS AND OATP1B SUBSTRATES | ||||||||
| Regulatory Exclusivity Expiration: | Oct 29, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Oct 29, 2027 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOID LEUKEMIA (PH+ CML) IN CHRONIC PHASE (CP) | ||||||||
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