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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 213591


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NDA 213591 describes TABRECTA, which is a drug marketed by Novartis Pharm and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the TABRECTA profile page.

The generic ingredient in TABRECTA is capmatinib hydrochloride. One supplier is listed for this compound. Additional details are available on the capmatinib hydrochloride profile page.
Summary for 213591
Tradename:TABRECTA
Applicant:Novartis Pharm
Ingredient:capmatinib hydrochloride
Patents:6
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213591
Generic Entry Date for 213591*:
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: 213591
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABRECTA capmatinib hydrochloride TABLET;ORAL 213591 NDA Novartis Pharmaceuticals Corporation 0078-0709 0078-0709-56 56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-56)
TABRECTA capmatinib hydrochloride TABLET;ORAL 213591 NDA Novartis Pharmaceuticals Corporation 0078-0709 0078-0709-94 56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-94)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:May 6, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:May 6, 2027
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE A MUTATION THAT LEADS TO MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING AS DETECTED BY AN FDA-APPROVED TEST
Regulatory Exclusivity Expiration:May 6, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Sign UpPatent Expiration:Jul 22, 2035Product Flag?YSubstance Flag?YDelist Request?

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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.