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Ayvakit

avapritinib · Tablet, Film Coated

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
Ayvakit
Generic name
avapritinib
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Blueprint Medicines Corporation
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
5
NDC product codes
5
Packages
5
Data completeness
60% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Avapritinib 100 mg/1 — —
Avapritinib 200 mg/1 — —
Avapritinib 25 mg/1 — —
Avapritinib 300 mg/1 — —
Avapritinib 50 mg/1 — —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
10

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Bile Salt Export Pump Inhibitors [MoA] MoA 1 member — no class page
Breast Cancer Resistance Protein Inhibitors [MoA] MoA All 44 members
Cytochrome P450 2C9 Inhibitors [MoA] MoA All 34 members
Kinase Inhibitor [EPC] EPC All 89 members
Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA] MoA 9 members — no class page
Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA] MoA 3 members — no class page
P-Glycoprotein Inhibitors [MoA] MoA All 105 members
Tyrosine Kinase Inhibitors [MoA] MoA 6 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
212608
Application type
NDA · New Drug Application
Approval date
January 9, 2020
Sponsor
BLUEPRINT MEDICINES
Products on application
5
Submissions recorded
6
Products approved under application 212608.
Product Trade name Form Strength Ingredient Status TE Flags
212608-001 AYVAKIT TABLET AVAPRITINIB Prescription — RLD
212608-002 AYVAKIT TABLET AVAPRITINIB Prescription — RLD
212608-003 AYVAKIT TABLET AVAPRITINIB Prescription — RLD RS
212608-004 AYVAKIT TABLET AVAPRITINIB Prescription — RLD
212608-005 AYVAKIT TABLET AVAPRITINIB Prescription — RLD

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
9944651 October 15, 2034 001 Yes U-2726 February 5, 2020
9994575 October 15, 2034 001 Yes U-2726 February 5, 2020
9200002 October 15, 2034 001 Yes U-2726 February 5, 2020
9200002 October 15, 2034 001 Yes U-3168 February 5, 2020
9944651 October 15, 2034 001 Yes U-3168 February 5, 2020
9994575 October 15, 2034 001 Yes U-3168 February 5, 2020
9994575 October 15, 2034 002 Yes U-2726 February 5, 2020
9200002 October 15, 2034 002 Yes U-2726 February 5, 2020
9944651 October 15, 2034 002 Yes U-2726 February 5, 2020
9200002 October 15, 2034 002 Yes U-3168 February 5, 2020
9944651 October 15, 2034 002 Yes U-3168 February 5, 2020
9994575 October 15, 2034 002 Yes U-3168 February 5, 2020
9944651 October 15, 2034 003 Yes U-2726 February 5, 2020
9994575 October 15, 2034 003 Yes U-2726 February 5, 2020
9200002 October 15, 2034 003 Yes U-2726 February 5, 2020
9200002 October 15, 2034 004 Yes U-3168 July 13, 2021
9944651 October 15, 2034 004 Yes U-3168 July 13, 2021
9994575 October 15, 2034 004 Yes U-3168 July 13, 2021
9944651 October 15, 2034 004 Yes U-3506 July 13, 2021
9994575 October 15, 2034 004 Yes U-3506 July 13, 2021
9200002 October 15, 2034 004 Yes U-3506 July 13, 2021
11827642 October 15, 2034 004 Yes U-3506 December 21, 2023
9200002 October 15, 2034 005 Yes U-3168 July 13, 2021
9944651 October 15, 2034 005 Yes U-3168 July 13, 2021
9994575 October 15, 2034 005 Yes U-3168 July 13, 2021
11999744 April 10, 2040 001 No U-3168 June 5, 2024
11964980 April 10, 2040 001 Yes April 23, 2024
11999744 April 10, 2040 002 No U-3168 June 5, 2024
11964980 April 10, 2040 002 Yes April 23, 2024
11964980 April 10, 2040 003 Yes April 23, 2024
11999744 April 10, 2040 004 No U-3168 June 5, 2024
11999744 April 10, 2040 004 No U-3506 June 5, 2024
12252494 April 10, 2040 004 No U-3506 April 16, 2025
11964980 April 10, 2040 004 Yes April 23, 2024
11999744 April 10, 2040 005 No U-3168 June 5, 2024
11964980 April 10, 2040 005 Yes April 23, 2024
12060354 March 8, 2042 001 No U-2726 August 14, 2024
12060354 March 8, 2042 002 No U-2726 August 14, 2024
12060354 March 8, 2042 003 No U-2726 August 14, 2024
Regulatory exclusivity periods.
Code Expires Product
I-912 May 22, 2026 004
ODE-366 January 9, 2027 001
ODE-366 January 9, 2027 002
ODE-366 January 9, 2027 003
ODE-366 January 9, 2027 004
ODE-366 January 9, 2027 005
ODE-356 June 16, 2028 001
ODE-356 June 16, 2028 002
ODE-356 June 16, 2028 003
ODE-356 June 16, 2028 004
ODE-356 June 16, 2028 005
ODE-434 May 22, 2030 001
ODE-434 May 22, 2030 002
ODE-434 May 22, 2030 003
ODE-434 May 22, 2030 004
ODE-434 May 22, 2030 005

Approval history

Source: Drugs@FDA
Most recent submissions on application 212608.
Type No. Action Status Date Review
Supplement 20 Labeling Approved November 8, 2024 Standard
Supplement 13 Efficacy Approved May 22, 2023 Priority
Supplement 12 Labeling Approved March 9, 2023 Standard
Supplement 7 Efficacy Approved June 16, 2021 Priority
Supplement 6 Efficacy Approved June 16, 2021 Priority
Original application 1 Type 1 - New Molecular Entity Approved January 9, 2020 Priority

Review documents

  • 0 · Supplement · February 24, 2026
  • 0 · Supplement · November 12, 2024
  • 0 · Supplement · November 12, 2024
  • 0 · Supplement · October 25, 2023
  • 0 · Supplement · May 23, 2023
  • 0 · Supplement · May 23, 2023
  • 0 · Supplement · March 10, 2023
  • 0 · Supplement · March 10, 2023
  • 0 · Supplement · December 9, 2022
  • 0 · Supplement · June 17, 2021
  • 0 · Supplement · June 17, 2021
  • 0 · Supplement · June 16, 2021
  • 0 · Supplement · June 16, 2021
  • 0 · Original application · February 13, 2020
  • 0 · Original application · January 10, 2020
  • 0 · Original application · January 9, 2020

Adverse event reports

Source: openFDA FAERS
0
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
72064-110-30 72064-110 Blueprint Medicines Corporation 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-110-30) January 9, 2020
72064-120-30 72064-120 Blueprint Medicines Corporation 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-120-30) January 9, 2020
72064-125-30 72064-125 Blueprint Medicines Corporation 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-125-30) June 16, 2021
72064-130-30 72064-130 Blueprint Medicines Corporation 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-130-30) January 9, 2020
72064-150-30 72064-150 Blueprint Medicines Corporation 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-150-30) June 16, 2021
72064-110 72064-110 Blueprint Medicines Corporation — January 9, 2020
72064-120 72064-120 Blueprint Medicines Corporation — January 9, 2020
72064-125 72064-125 Blueprint Medicines Corporation — June 16, 2021
72064-130 72064-130 Blueprint Medicines Corporation — January 9, 2020
72064-150 72064-150 Blueprint Medicines Corporation — June 16, 2021

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity

Generated September 25, 2026 · 10 sections on this page.