Prescription medicine
Sevabertinib Brand names: Hyrnuo
Sevabertinib (Hyrnuo) 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 sevabertinib FDA label on DailyMed (effective March 4, 2026, Bayer HealthCare Pharmaceuticals Inc.); the NDA 219972 record on Drugs@FDA; every sevabertinib label on DailyMed.
Highlights of the record
FDA label of March 4, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageHYRNUO is indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 ( ERBB2 ) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1) ], and who have received a prior systemic therapy.
Forms and strengths
- 10 mg
Film-coated tablet.
On the market
- Earliest approval on file
- November 19, 2025 Hyrnuo, Bayer Healthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 14, 2043 Hyrnuo 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
What is sevabertinib used for?
From the label: indications and usageHYRNUO is indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 ( ERBB2 ) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1) ], and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. […]
Conditions named in the indications of sevabertinib's FDA labels, with every medicine labeled for each:
Source: FDA drug label (HYRNUO), Bayer HealthCare Pharmaceuticals Inc., effective March 4, 2026 (SPL set d7a11334-6e7a-445b-9a16-bdcd9acbe61f), via openFDA; the full label on DailyMed
What does the patient leaflet for sevabertinib 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 HYRNUO?Avoid eating grapefruit or drinking grapefruit juice during treatment with HYRNUO. Grapefruit may increase the amount of HYRNUO in your blood.
From the patient leaflet: How should I store HYRNUO?Store HYRNUO at room temperature between 68°F to 77°F (20°C to 25°C). HYRNUO comes in a child-resistant container. Keep HYRNUO and all medicines out of the reach of children.
Source: FDA drug label (HYRNUO), Bayer HealthCare Pharmaceuticals Inc., effective March 4, 2026 (SPL set d7a11334-6e7a-445b-9a16-bdcd9acbe61f), via openFDA; the full label on DailyMed
Is there a generic for sevabertinib (Hyrnuo)?
No generic sevabertinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Hyrnuo tablets: the compound patent runs to November 14, 2043. 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
- 2043 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the sevabertinib label say about other medicines?
The sevabertinib 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 |
|---|---|---|
| Loperamide | warnings and precautions | At the first sign of diarrhea or increased bowel movement frequency, instruct patients to start an antidiarrheal treatment (e.g., loperamide [refer to full Prescribing Information] ), and to increase their fluid and electrolyte intake. |
Source: FDA drug label (HYRNUO), Bayer HealthCare Pharmaceuticals Inc., effective March 4, 2026 (SPL set d7a11334-6e7a-445b-9a16-bdcd9acbe61f), via openFDA; the full label on DailyMed
What else is labeled for the same conditions as sevabertinib?
26 other medicines are given the same way (oral) and in the same FDA class as sevabertinib 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 sevabertinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to sevabertinib
- 26 medicines for the same use
- Check an interaction
- what two or more labels say about each other