Viewing data from:

AYVAKIT

NDA

AVAPRITINIB | N212608 | BLUEPRINT MEDICINES CORP

5 strengths8 unique patents4 unique exclusivities

Patent Timeline

8 unique patents, 4 exclusivities by expiration date

Active (8)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

Today

Oct. 15, 2034

Oct. 15, 2034

Oct. 15, 2034

Oct. 15, 2034

Apr. 10, 2040

Apr. 10, 2040

Mar. 8, 2042

Apr. 10, 2040

I-912

May. 22, 2026

ODE-366

Jan. 9, 2027

ODE-356

Jun. 16, 2028

ODE-434

May. 22, 2030

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Ayvakit (2023)

Total Spending

$55.2M

Total Claims

1,398

Beneficiaries

267

Avg Cost/Unit

$1247.64

Spending Trend

$6.9M(2020)→$15.5M(2021)→$32.3M(2022)→$55.2M(2023)

YoY Change:+5.2%

5yr CAGR:+4.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Nov 12, 2024	SUPPL -20	View Letter (PDF)
May 23, 2023	SUPPL -13	View Letter (PDF)
Mar 10, 2023	SUPPL -12	View Letter (PDF)
Jun 17, 2021	SUPPL -6	View Letter (PDF)
Jun 17, 2021	SUPPL -7	View Letter (PDF)
Jan 10, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 100MG

RLD

6 patents3 exclusivities▴

TABLET;ORAL | Approved: Jan 9, 2020

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9200002	Oct 15, 2034	—	Yes	Yes		—
9944651	Oct 15, 2034	—	Yes	Yes		—
9994575	Oct 15, 2034	—	Yes	Yes		—
11964980	Apr 10, 2040	—	Yes	Yes	—	—
11999744	Apr 10, 2040	—	—	—		—
12060354	Mar 8, 2042	—	—	—		—

Exclusivities (3)

Code	Date	Status
ODE-356	Jun 16, 2028	Active
ODE-366	Jan 9, 2027	< 1 year
ODE-434	May 22, 2030	Active

#002 — 200MG

RLD

6 patents3 exclusivities▾

TABLET;ORAL | Approved: Jan 9, 2020

#003 — 300MG

RLD

5 patents3 exclusivities▾

TABLET;ORAL | Approved: Jan 9, 2020

#004 — 25MG

RLD

7 patents4 exclusivities▾

TABLET;ORAL | Approved: Jun 16, 2021

#005 — 50MG

RLD

5 patents3 exclusivities▾

TABLET;ORAL | Approved: Jun 16, 2021