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Alunbrig

brigatinib · 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. Report adverse events to FDA MedWatch.

Overview

Brand name
Alunbrig
Generic name
brigatinib
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Takeda Pharmaceuticals America, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
4
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Brigatinib 180 mg/1 1921222 —
Brigatinib 30 mg/1 1921222 —
Brigatinib 90 mg/1 1921222 —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
7

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
Cytochrome P450 3A Inducers [MoA] MoA All 37 members
Kinase Inhibitor [EPC] EPC All 89 members
Tyrosine Kinase Inhibitors [MoA] MoA 6 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
208772
Application type
NDA · New Drug Application
Approval date
April 28, 2017
Sponsor
TAKEDA PHARMS USA
Products on application
3
Submissions recorded
6
Products approved under application 208772.
Product Trade name Form Strength Ingredient Status TE Flags
208772-001 ALUNBRIG TABLET BRIGATINIB Prescription — RLD
208772-002 ALUNBRIG TABLET BRIGATINIB Prescription — RLD RS
208772-003 ALUNBRIG TABLET BRIGATINIB 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
9273077 May 21, 2029 001 No U-2837 May 26, 2017
9273077 May 21, 2029 002 No U-2837 May 26, 2017
9273077 May 21, 2029 003 No U-2837 October 23, 2017
9012462 April 28, 2031 001 Yes May 26, 2017
9012462 April 28, 2031 002 Yes May 26, 2017
9012462 April 28, 2031 003 Yes October 23, 2017
9611283 April 10, 2034 001 No U-2837 May 26, 2017
9611283 April 10, 2034 002 No U-2837 May 26, 2017
9611283 April 10, 2034 003 No U-2837 October 23, 2017
10385078 November 10, 2035 001 Yes U-2837 September 10, 2019
10385078 November 10, 2035 002 Yes U-2837 September 10, 2019
10385078 November 10, 2035 003 Yes U-2837 September 10, 2019
Regulatory exclusivity periods.
Code Expires Product
ODE-300 May 22, 2027 001
ODE-300 May 22, 2027 002
ODE-300 May 22, 2027 003

Approval history

Source: Drugs@FDA
Most recent submissions on application 208772.
Type No. Action Status Date Review
Supplement 13 Efficacy Approved February 28, 2022 Standard
Supplement 12 Labeling Approved September 24, 2021 Standard
Supplement 8 Efficacy Approved May 22, 2020 Priority
Supplement 4 Efficacy Approved December 21, 2018 Standard
Supplement 2 Manufacturing (CMC) Approved October 2, 2017 N/A
Original application 1 Type 1 - New Molecular Entity Approved April 28, 2017 Priority

Review documents

  • 0 · Supplement · March 3, 2022
  • 0 · Supplement · March 1, 2022
  • 0 · Supplement · September 29, 2021
  • 0 · Supplement · September 28, 2021
  • 0 · Supplement · May 28, 2020
  • 0 · Supplement · May 22, 2020
  • 0 · Supplement · December 31, 2018
  • 0 · Supplement · December 26, 2018
  • 0 · Original application · May 30, 2017
  • 0 · Original application · April 28, 2017
  • 0 · Original application · April 28, 2017

Adverse event reports

Source: openFDA FAERS
3,630
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.

Attributed to this product's most-reported active ingredient: BRIGATINIB. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

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
63020-090-07 63020-090 Takeda Pharmaceuticals America, Inc. 7 TABLET, FILM COATED in 1 BOTTLE (63020-090-07) October 2, 2017
63020-090-30 63020-090 Takeda Pharmaceuticals America, Inc. 30 TABLET, FILM COATED in 1 BOTTLE (63020-090-30) October 2, 2017
63020-113-30 63020-113 Takeda Pharmaceuticals America, Inc. 30 TABLET, FILM COATED in 1 BOTTLE (63020-113-30) October 2, 2017
63020-180-30 63020-180 Takeda Pharmaceuticals America, Inc. 30 TABLET, FILM COATED in 1 BOTTLE (63020-180-30) October 2, 2017
63020-090 63020-090 Takeda Pharmaceuticals America, Inc. — April 28, 2017
63020-113 63020-113 Takeda Pharmaceuticals America, Inc. — April 28, 2017
63020-180 63020-180 Takeda Pharmaceuticals America, Inc. — April 28, 2017

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
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.