Prescription medicine
Lorlatinib Brand names: Lorbrena
Lorlatinib (Lorbrena) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
- A presentation discontinued
Check it at the source: the lorlatinib FDA label on DailyMed (effective June 26, 2026, Pfizer Laboratories Div Pfizer Inc); the NDA 210868 record on Drugs@FDA; every lorlatinib label on DailyMed.
Highlights of the record
FDA label of June 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageLORBRENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
Forms and strengths
- 25 mg
- 100 mg
Film-coated tablet.
On the market
- Earliest approval on file
- November 2, 2018 Lorbrena, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- October 4, 2038 Lorbrena tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 6,977 through July 30, 2026
What is lorlatinib used for?
From the label: indications and usageLORBRENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. LORBRENA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
Conditions named in the indications of lorlatinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Lorbrena), Pfizer Laboratories Div Pfizer Inc, effective June 26, 2026 (SPL set 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d), via openFDA; the full label on DailyMed
What does the patient leaflet for lorlatinib 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 LORBRENA?LORBRENA can cause serious side effects, including: • Liver problems due to interactions with other medicines. Liver problems can be severe. It is important to know what medicines not to take during treatment with LORBRENA. See “ Tell your healthcare provider about all the medicines you take, including .” • Central nervous system (CNS) effects. CNS effects can be severe. Tell your healthcare provider if you get any new or worsening symptoms of CNS effects, including: o problems with thinking, such as forgetfulness or confusion o changes in mood, such as depression and thoughts about suicide or dying o psychotic effects, such as seeing or hearing things that are not real (hallucinations) o seizures o changes in speech o changes in sleep • Increases in the cholesterol and triglycerides (lipid) levels in your blood. […] Tell your healthcare provider right away if you get signs or symptoms of high blood pressure, including: headaches, dizziness, blurred vision, chest pain or shortness of breath. • High blood sugar (hyperglycemia). LORBRENA can cause new or worsening increases in your blood sugar levels. Your healthcare provider will do blood tests to check your blood sugar levels before starting and during treatment with LORBRENA. Your healthcare provider may start or change your blood sugar medicine if you get high blood sugar. […]
From the patient leaflet: How should I store LORBRENA?Store LORBRENA at room temperature between 68°F to 77°F (20°C to 25°C). • LORBRENA comes in a bottle that contains a child resistant cap. Keep LORBRENA and all medicines out of the reach of children.
Source: FDA drug label (Lorbrena), Pfizer Laboratories Div Pfizer Inc, effective June 26, 2026 (SPL set 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d), via openFDA; the full label on DailyMed
Is there a generic for lorlatinib (Lorbrena)?
No generic lorlatinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Lorbrena tablets: the compound patent runs to October 4, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is lorlatinib in shortage?
No lorlatinib presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated June 15, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Lorbrena, Tablet, 25 mg; 120 tablets bottle with a child-resistant closure (NDC 0069-0227-03) | Pfizer Inc. | To Be Discontinued | June 15, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the lorlatinib label say about other medicines?
The lorlatinib label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Fluconazole | drug interactions | Fluconazole Avoid concomitant use of LORBRENA with fluconazole. |
| Rifampin | drug interactions | Severe hepatotoxicity occurred in healthy subjects receiving LORBRENA with rifampin, a strong CYP3A inducer. |
Source: FDA drug label (Lorbrena), Pfizer Laboratories Div Pfizer Inc, effective June 26, 2026 (SPL set 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d), via openFDA; the full label on DailyMed
What do FAERS reports show for lorlatinib?
The FDA Adverse Event Reporting System holds 6,977 reports that list lorlatinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,867 are coded as a death and 1,530 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 lorlatinib?
26 other medicines are given the same way (oral) and in the same FDA class as lorlatinib 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 |
| Brigatinib | Lung cancer | none listed | n/a | No current entry |
| Dabrafenib | Lung cancer | none listed | n/a | No current entry |
| Trametinib | Lung cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as lorlatinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to lorlatinib
- 26 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Lorlatinib side effects
- the label's list beside FAERS reports
- Lorlatinib shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other