Details for New Drug Application (NDA): 213591

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 seven patents protecting this drug. Additional details are available on the TABRECTA profile page.

The generic ingredient in TABRECTA is capmatinib hydrochloride. There is one drug master file entry for this compound. 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:	7

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 213591

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: 213591

Mechanism of Action

Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inhibitors Mesenchymal Epithelial Transition Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Multidrug and Toxin Extrusion Transporter 2 K Inhibitors P-Glycoprotein Inhibitors

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:	RX	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE
Approval Date:	May 6, 2020	TE:		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
Patent:		Patent Expiration:	Jul 22, 2035	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:		Patent Expiration:	Nov 19, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	USE FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING MUTATION

Complete Access Available with Subscription