Prescription medicine
Ensartinib Brand names: Ensacove
Ensartinib (Ensacove) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ensartinib FDA label on DailyMed (effective February 17, 2026, Xcovery Holdings, Inc.); the NDA 218171 record on Drugs@FDA; every ensartinib label on DailyMed.
Highlights of the record
FDA label of February 17, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageENSACOVE is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)as detected by an FDA-approved test [see Dosage and Administration ( 2.1 )] who have not previously received an ALK-inhibitor.
Forms and strengths
- 25 mg
- 100 mg
Capsule.
On the market
- Earliest approval on file
- December 18, 2024 Ensacove, Xcovery; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- June 1, 2037 Ensacove capsules; 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
- 32 through July 30, 2026
What is ensartinib used for?
From the label: indications and usageENSACOVE is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)as detected by an FDA-approved test [see Dosage and Administration ( 2.1 )] who have not previously received an ALK-inhibitor. ENSACOVE is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test who have not previously received an ALK-inhibitor.
Conditions named in the indications of ensartinib's FDA labels, with every medicine labeled for each:
Source: FDA drug label (ENSACOVE), Xcovery Holdings, Inc., effective February 17, 2026 (SPL set 1e1b2f79-678a-472a-b924-66909c8a4b2e), via openFDA; the full label on DailyMed
What does the patient leaflet for ensartinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking ENSACOVE?Limit your time in the sun during treatment with ENSACOVE and for at least 1 week after your last dose. ENSACOVE 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.
From the patient leaflet: How should I store ENSACOVE?Store ENSACOVE at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Keep ENSACOVE capsules in the original bottle. The bottle of ENSACOVE capsules contains a drying agent (desiccant) to help keep your medicine dry. Do not remove the desiccant from the bottle after opening. Do not open or eat the desiccant. Keep ENSACOVE and all medicines out of the reach of children.
Source: FDA drug label (ENSACOVE), Xcovery Holdings, Inc., effective February 17, 2026 (SPL set 1e1b2f79-678a-472a-b924-66909c8a4b2e), via openFDA; the full label on DailyMed
Is there a generic for ensartinib (Ensacove)?
No generic ensartinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Ensacove capsules: the compound patent runs to June 1, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ensartinib label say about other medicines?
The ensartinib label names 1 other medicine 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 |
|---|---|---|
| Aspirin | warnings and precautions | Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. |
Source: FDA drug label (ENSACOVE), Xcovery Holdings, Inc., effective February 17, 2026 (SPL set 1e1b2f79-678a-472a-b924-66909c8a4b2e), via openFDA; the full label on DailyMed
What do FAERS reports show for ensartinib?
The FDA Adverse Event Reporting System holds 32 reports that list ensartinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 7 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.
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 ensartinib?
26 other medicines are given the same way (oral) and in the same FDA class as ensartinib 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 |
| Dacomitinib | Lung cancer | none listed | n/a | A presentation being discontinued |
Every medicine labeled for the same conditions as ensartinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ensartinib
- 26 medicines for the same use
- Ensartinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other