Prescription medicine

Avapritinib Brand names: Ayvakit

Avapritinib (Ayvakit) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the avapritinib FDA label on DailyMed (effective August 5, 2026, Blueprint Medicines Corporation); the NDA 212608 record on Drugs@FDA; every avapritinib label on DailyMed.

Highlights of the record

FDA label of August 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
AYVAKIT is a kinase inhibitor indicated for: Gastrointestinal Stromal Tumor (GIST) 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.

Forms and strengths

25 mg
50 mg
100 mg
200 mg
300 mg

Film-coated tablet.

On the market

Earliest approval on file: January 9, 2020 Ayvakit, Blueprint Medicines; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: March 8, 2042 Ayvakit tablets; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded

What is avapritinib used for?

From the label: indications and usage
AYVAKIT is a kinase inhibitor indicated for: Gastrointestinal Stromal Tumor (GIST) 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. ( 1.1 , 2.2 ) Advanced Systemic Mastocytosis (AdvSM) the treatment of adult patients with AdvSM. AdvSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). […]

FDA pharmacologic class: Kinase Inhibitor.

Source: FDA drug label (Ayvakit), Blueprint Medicines Corporation, effective August 5, 2026 (SPL set 645c887c-8cd4-4623-8da9-ac223d71a8b9), via openFDA; the full label on DailyMed

What does the patient leaflet for avapritinib say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What should I avoid while taking AYVAKIT?
Do not drive or operate heavy machinery if you have confusion or trouble thinking during treatment with AYVAKIT. Your skin may be sensitive to the sun or other forms of light (photosensitivity) during treatment with AYVAKIT. Avoid or limit exposure to direct sunlight, sunlamps, and other sources of ultraviolet radiation during treatment and for 1 week after stopping treatment with AYVAKIT. Use sunscreen or wear clothes that cover your skin if you need to be out in the sun.

From the patient leaflet: How should I store AYVAKIT?
Store AYVAKIT tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep AYVAKIT and all medicines out of the reach of children.

Source: FDA drug label (Ayvakit), Blueprint Medicines Corporation, effective August 5, 2026 (SPL set 645c887c-8cd4-4623-8da9-ac223d71a8b9), via openFDA; the full label on DailyMed

Is there a generic for avapritinib (Ayvakit)?

No generic avapritinib is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 8 patents for Ayvakit tablets: the compound patent runs to April 10, 2040, and the last listed entry to March 8, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2020 earliest approval on file
2042 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What next?

Other kinase inhibitors: the pharmacologic class, with prices and generics
Check an interaction: what two or more labels say about each other