Prescription medicine
Brigatinib Brand names: Alunbrig
Brigatinib (Alunbrig) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the brigatinib FDA label on DailyMed (effective January 12, 2026, Takeda Pharmaceuticals America, Inc.); the NDA 208772 record on Drugs@FDA; every brigatinib label on DailyMed.
Highlights of the record
FDA label of January 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test [see Dosage and Administration (2.1) ].
Forms and strengths
- 30 mg
- 90 mg
- 180 mg
Film-coated tablet; kit.
On the market
- Earliest approval on file
- April 28, 2017 Alunbrig, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- November 10, 2035 Alunbrig 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
- FAERS reports
- 3,630 through July 30, 2026
What is brigatinib used for?
From the label: indications and usageALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test [see Dosage and Administration (2.1) ]. ALUNBRIG is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
Conditions named in the indications of brigatinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Alunbrig), Takeda Pharmaceuticals America, Inc., effective January 12, 2026 (SPL set 0fe9ff20-d402-41f3-bc1e-7002ea7007db), via openFDA; the full label on DailyMed
What does the patient leaflet for brigatinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ALUNBRIG?ALUNBRIG can cause serious side effects, including: Lung problems. ALUNBRIG may cause severe or life-threatening swelling (inflammation) of the lungs any time during treatment, and can lead to death. These lung problems happen especially within the first week of treatment with ALUNBRIG. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms, including: trouble breathing or shortness of breath chest pain cough with or without mucus fever High blood pressure (hypertension). ALUNBRIG may cause high blood pressure. Your healthcare provider will check your blood pressure before starting and during treatment with ALUNBRIG. Tell your healthcare provider right away if you get headaches, dizziness, blurred vision, chest pain or shortness of breath. Slow heart rate (bradycardia). ALUNBRIG may cause very slow heartbeats that can be severe. […] Tell your healthcare provider right away if you get new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness. Inflammation of the pancreas (pancreatitis). ALUNBRIG may increase enzymes in your blood called amylase and lipase, which may be a sign of pancreatitis. Your healthcare provider will do blood tests to check your pancreatic enzyme blood levels during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs and symptoms of pancreatitis, including upper abdominal pain that may spread to the back and get worse with eating, weight loss, or nausea. […]
From the patient leaflet: What should I avoid while taking ALUNBRIG?Limit your time in the sun during treatment with ALUNBRIG and for at least 5 days after your final dose. ALUNBRIG may make your skin sensitive to sunlight. You may burn more easily and get severe sunburns. When you are in the sun, wear a hat and protective clothing, and use a broad-spectrum sunscreen and lip balm with a Sun Protection Factor (SPF) of 30 or greater to protect against sunburn. Avoid eating grapefruit or drinking grapefruit juice during treatment with ALUNBRIG. Grapefruit may increase the amount of ALUNBRIG in your blood.
From the patient leaflet: How should I store ALUNBRIG?Store ALUNBRIG at room temperature between 68°F to 77°F (20°C to 25°C). Keep ALUNBRIG and all medicines out of the reach of children.
Source: FDA drug label (Alunbrig), Takeda Pharmaceuticals America, Inc., effective January 12, 2026 (SPL set 0fe9ff20-d402-41f3-bc1e-7002ea7007db), via openFDA; the full label on DailyMed
Is there a generic for brigatinib (Alunbrig)?
No generic brigatinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Alunbrig tablets: the compound patent runs to November 10, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for brigatinib?
The FDA Adverse Event Reporting System holds 3,630 reports that list brigatinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 786 are coded as a death and 995 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as brigatinib?
26 other medicines are given the same way (oral) and in the same FDA class as brigatinib or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Erlotinib | Lung cancer | 10 labelers | n/a | No current entry |
| Afatinib | Lung cancer | 1 labeler | n/a | No current entry |
| Selpercatinib | Lung cancer | none listed | n/a | No current entry |
| Crizotinib | Lung cancer | none listed | n/a | No current entry |
| Gefitinib | Lung cancer | 4 labelers | n/a | No current entry |
| Dabrafenib | Lung cancer | none listed | n/a | No current entry |
| Lorlatinib | Lung cancer | none listed | n/a | A presentation being discontinued |
| Trametinib | Lung cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as brigatinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to brigatinib
- 26 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Brigatinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other