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Last Updated: March 28, 2024

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 two patents protecting this drug. Additional details are available on the SCEMBLIX profile page.

The generic ingredient in SCEMBLIX is asciminib hydrochloride. 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:2
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:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Oct 29, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 29, 2026
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Oct 29, 2028
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOID LEUKEMIA (PH+ CML) IN CHRONIC PHASE (CP) WITH THE T315I MUTATION
Regulatory Exclusivity Expiration:Oct 29, 2028
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOID LEUKEMIA (PH+ CML) IN CHRONIC PHASE (CP), PREVIOUSLY TREATED WITH TWO OR MORE TYROSINE KINASE INHIBITORS (TKIS)

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.