Prescription medicine
Remibrutinib Brand names: Rhapsido
Remibrutinib (Rhapsido) is a prescription medicine with an FDA approval on record since 2025. No generic is listed; pharmacies paid $72.46 per Rhapsido 25 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the remibrutinib FDA label on DailyMed (effective March 23, 2026, Novartis Pharmaceuticals Corporation); the NDA 218436 record on Drugs@FDA; every remibrutinib label on DailyMed.
Highlights of the record
FDA label of March 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageRHAPSIDO ® is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment.
Forms and strengths
- 25 mg
Tablet.
On the market
- Earliest approval on file
- September 30, 2025 Rhapsido, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- January 19, 2043 Rhapsido tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $72.46 per tablet Rhapsido 25 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 972 through July 30, 2026
What is remibrutinib used for?
From the label: indications and usageRHAPSIDO ® is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. Limitations of Use: RHAPSIDO is not indicated for other forms of urticaria. RHAPSIDO ® is a kinase inhibitor indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. ( 1 ) Limitations of Use: Not indicated for other forms of urticaria.
Conditions named in the indications of remibrutinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (RHAPSIDO), Novartis Pharmaceuticals Corporation, effective March 23, 2026 (SPL set e5e89bff-6ced-4165-acc5-fb13136b3a3d), via openFDA; the full label on DailyMed
Is there a generic for remibrutinib (Rhapsido)?
No generic remibrutinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Rhapsido tablets: the compound patent runs to November 13, 2034, and the last listed entry to January 19, 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 do pharmacies pay for remibrutinib (Rhapsido)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $72.46 per Rhapsido 25 mg tablet. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Rhapsido 25 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Rhapsido 25 mg tablet | Brand | $72.46 per tablet | $2,173.87 | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the remibrutinib label say about other medicines?
The remibrutinib label names 3 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 |
|---|---|---|
| Clopidogrel | drug interactions | Use of the antiplatelet agents, acetyl salicylic acid at doses up to 100 mg daily or clopidogrel up to 75 mg daily, was allowed in the RHAPSIDO clinical studies. |
| Digoxin | drug interactions | Monitor more frequently for adverse reactions when using RHAPSIDO with P-glycoprotein (P-gp) substrates where minimal concentration changes may lead to serious adverse reactions (e.g., digoxin). |
| Salicylic acid | drug interactions | Use of the antiplatelet agents, acetyl salicylic acid at doses up to 100 mg daily or clopidogrel up to 75 mg daily, was allowed in the RHAPSIDO clinical studies. |
Source: FDA drug label (RHAPSIDO), Novartis Pharmaceuticals Corporation, effective March 23, 2026 (SPL set e5e89bff-6ced-4165-acc5-fb13136b3a3d), via openFDA; the full label on DailyMed
What do FAERS reports show for remibrutinib?
The FDA Adverse Event Reporting System holds 972 reports that list remibrutinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 22 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 remibrutinib?
10 other medicines are given the same way (oral) and in the same FDA class as remibrutinib or labeled mainly for the same use (allergies), the same class first. Allergies lists all 36 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 |
|---|---|---|---|---|
| Cetirizine | Allergies | 164 labelers | $0.0613 per tablet 10 mg tablet | No current entry |
| Fexofenadine | Allergies | 110 labelers | $0.230 per tablet 180 mg tablet | No current entry |
| Levocetirizine | Allergies | 53 labelers | $0.0511 per tablet 5 mg tablet | No current entry |
| Chlorpheniramine | Allergies | 2 labelers | $0.0177 per tablet 4 mg tablet | No current entry |
| Desloratadine | Allergies | 9 labelers | $0.258 per tablet 5 mg tablet | No current entry |
| Carbinoxamine | Allergies | 7 labelers | $0.398 per tablet 4 mg tablet | No current entry |
| Chlorpheniramine and ibuprofen and phenylephrine | Allergies | none listed | n/a | No current entry |
| Clemastine | Allergies | 3 labelers | $3.18 per tablet 2.68 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Remibrutinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other