Prescription medicine
Taletrectinib adipate Brand names: Ibtrozi
Taletrectinib adipate (Ibtrozi) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the taletrectinib adipate FDA label on DailyMed (effective March 23, 2026, Nuvation Bio Inc.); the NDA 219713 record on Drugs@FDA; every taletrectinib adipate label on DailyMed.
Highlights of the record
FDA label of March 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageIBTROZI ® (taletrectinib) is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) [see Dosage and Administration ( 2.1 )].
Forms and strengths
- 272 mg
Capsule.
On the market
- Earliest approval on file
- June 11, 2025 Ibtrozi, Nuvation; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 3, 2033 Ibtrozi 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
What is taletrectinib adipate used for?
From the label: indications and usageIBTROZI ® (taletrectinib) is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) [see Dosage and Administration ( 2.1 )]. IBTROZI is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC).
Conditions named in the indications of taletrectinib adipate's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (IBTROZI), Nuvation Bio Inc., effective March 23, 2026 (SPL set 51ac8e52-3269-4102-8dc8-dba22d82128c), via openFDA; the full label on DailyMed
What does the patient leaflet for taletrectinib adipate 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 IBTROZI?You should limit time in the sun during treatment with IBTROZI. IBTROZI may make your skin sensitive to sunlight. Wear a hat and clothes that cover your skin and use sunscreen with sun protective factor (SPF) if you are in the sun during treatment with IBTROZI and for at least 5 days after your last dose of IBTROZI. You should avoid grapefruit, grapefruit juice, or products that contain grapefruit during your treatment with IBTROZI. Grapefruit may increase the amount of IBTROZI in your blood, which may increase the risk of IBTROZI side effects.
From the patient leaflet: How should I store IBTROZI?Store IBTROZI at room temperature between 68°F to 77°F (20°C to 25°C). Keep IBTROZI and all medicines out of the reach of children.
Source: FDA drug label (IBTROZI), Nuvation Bio Inc., effective March 23, 2026 (SPL set 51ac8e52-3269-4102-8dc8-dba22d82128c), via openFDA; the full label on DailyMed
Is there a generic for taletrectinib adipate (Ibtrozi)?
No generic taletrectinib adipate is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Ibtrozi capsules: the compound patent runs to June 3, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What else is labeled for the same conditions as taletrectinib adipate?
26 other medicines are given the same way (oral) and in the same FDA class as taletrectinib adipate 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 |
| Lorlatinib | Lung cancer | none listed | n/a | A presentation being discontinued |
Every medicine labeled for the same conditions as taletrectinib adipate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to taletrectinib adipate
- 26 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other