Details for New Drug Application (NDA): 212608

NDA 212608 describes AYVAKIT, which is a drug marketed by Blueprint Medicines 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 AYVAKIT profile page.

The generic ingredient in AYVAKIT is avapritinib. One supplier is listed for this compound. Additional details are available on the avapritinib profile page.

Summary for 212608

Tradename:	AYVAKIT
Applicant:	Blueprint Medicines
Ingredient:	avapritinib
Patents:	4

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 212608

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: 212608

Mechanism of Action

Bile Salt Export Pump Inhibitors Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C9 Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Multidrug and Toxin Extrusion Transporter 2 K Inhibitors P-Glycoprotein Inhibitors Tyrosine Kinase Inhibitors

Suppliers and Packaging for NDA: 212608

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AYVAKIT	avapritinib	TABLET;ORAL	212608	NDA	Blueprint Medicines Corporation	72064-110	72064-110-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-110-30)
AYVAKIT	avapritinib	TABLET;ORAL	212608	NDA	Blueprint Medicines Corporation	72064-120	72064-120-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-120-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Jan 9, 2020	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 16, 2028
Regulatory Exclusivity Use:	FOR THE TREATMENT OF ADULT PATIENTS WITH ADVANCED SYSTEMIC MASTOCYTOSIS (ADVSM). ADVSM INCLUDES PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH AN ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), AND MAST CELL LEUKEMIA (MCL)
Regulatory Exclusivity Expiration:	Jan 9, 2027
Regulatory Exclusivity Use:	INDICATED FOR THE TREATMENT OF ADULTS WITH UNRESECTABLE OR METASTATIC GIST HARBORING A PLATELET-DERIVED GROWTH FACTOR RECEPTOR ALPHA (PDGFRA) EXON 18 MUTATION, INCLUDING PDGFRA D842V MUTATIONS
Regulatory Exclusivity Expiration:	Jan 9, 2025
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY

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