Viewing data from:

ALUNBRIG

NDA

BRIGATINIB | N208772 | TAKEDA PHARMACEUTICALS USA INC

3 strengths4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Active (4)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Apr. 28, 2031

May. 21, 2029

Apr. 10, 2034

Nov. 10, 2035

ODE-300

May. 22, 2027

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

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Advancing Brigatinib Properties in ALK+ NSCLC Patients by Deep Phenotyping NCT04318938	Phase 2	Completed	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest	118	2020-03-30 → 2026-05-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Alunbrig (2023)

Total Spending

$33.3M

Total Claims

1,733

Beneficiaries

237

Avg Cost/Unit

$544.24

Spending Trend

$14.5M(2019)→$15.8M(2020)→$19.4M(2021)→$27.8M(2022)→$33.3M(2023)

YoY Change:+5.2%

5yr CAGR:+3.3%

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Mar 1, 2022	SUPPL -13	View Letter (PDF)
Sep 28, 2021	SUPPL -12	View Letter (PDF)
May 28, 2020	SUPPL -8	View Letter (PDF)
Dec 31, 2018	SUPPL -4	View Letter (PDF)
Apr 28, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 30MG

RLD

4 patents1 exclusivity▴

TABLET;ORAL | Approved: Apr 28, 2017

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9012462	Apr 28, 2031	—	Yes	—	—	—
9273077	May 21, 2029	—	—	—		—
9611283	Apr 10, 2034	—	—	—		—
10385078	Nov 10, 2035	—	Yes	Yes		—

Exclusivities (1)

Code	Date	Status
ODE-300	May 22, 2027	< 1 year

#002 — 90MG

RLD

4 patents1 exclusivity▾

TABLET;ORAL | Approved: Apr 28, 2017

#003 — 180MG

RLD

4 patents1 exclusivity▾

TABLET;ORAL | Approved: Oct 2, 2017