Rhapsido Generic: When Will Generic Remibrutinib Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Rhapsido Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? January 2043 About 16.5 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? January 2043 3 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic remibrutinib is expected to be available in January 2043, about 16.5 years away. None is for sale yet.
Why January 2043?
It is when Rhapsido’s patent 12,419,889 ends. That patent covers a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them. It is too early to rate how firm that is.
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Rhapsido as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Rhapsido by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Not rated Too early to rate. The month is where the records point today.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2025 September 2025 FDA Orange Book
- Patents listed 3 last runs to January 2043 FDA Orange Book
- Pharmacies pay $72.46 per tablet NADAC, October 2026
- Medicare Part D spent $2.2M in 2025, for 291 people CMS Part D Spending by Drug
- Medicaid prescriptions 12 in the last four reported quarters, $54.4K CMS Medicaid drug utilization, to Q4 2025
Rhapsido’s Road to a Generic
Rhapsido has had the market to itself since the FDA approved it in September 2025 (Novartis Pharmaceuticals Corp). Its FDA protection (new chemical entity) runs to September 2030. Its 3 listed patents run to January 2043.
The first generic of Rhapsido is expected in January 2043.
Why that month: patent 12,419,889, on a way of using it, ends then.
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Rhapsido Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Rhapsido’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
The one that matters for a generic launch: patent 12,419,889, which ends in January 2043, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,512,084 | The active ingredient; the product’s formulation | November 2034 | Active |
| 10,457,647 | A way of using it (U-4280) | November 2034 | Active |
| 12,419,889 Sets the expected month of generic availability | A way of using it (U-4281) | January 2043 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | September 2030 | Active |
Source: FDA Orange Book, application 218436. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Remibrutinib
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No company is recorded as having applied to the FDA to make a generic Rhapsido yet.
Approved by the FDA
Not yet. The FDA has not approved a generic remibrutinib. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic remibrutinib for sale with the FDA.
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Rhapsido Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Rhapsido 25 mg tablet
$72.46 per tablet in October 2026.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per tablet |
|---|---|
| October 2026 | $72.46 |
| September 2026 | $72.46 |
| August 2026 | $72.53 |
| July 2026 | $72.43 |
| June 2026 | $72.26 |
| May 2026 | $72.01 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Rhapsido today: $72.46 per tablet for Rhapsido 25 mg tablet in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Dollar figures apply FDA’s median drops to the $72.46 pharmacies pay per tablet today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Rhapsido
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Rhapsido, before manufacturer rebates.
- $6.6M
- January to March 2026, the latest CMS has posted
For 733 people, about $5,003 per prescription fill - $2.2M
- 2025, the whole year
For 291 people, about $5,241 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $6,588,648 | 733 | $5,002.77 |
| 2025 | $2,196,158 | 291 | $5,241.43 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Rhapsido only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat hives from an unknown cause (chronic spontaneous urticaria-CSU). Remibrutinib belongs to a class of drugs known as kinase inhibitors.
Rhapsido Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 25MG | Tablet | Oral | September 2025 | Prescription reference product |
Source: FDA Orange Book, Novartis Pharmaceuticals Corp. Listed for sale today by Novartis Pharmaceuticals Corporation (FDA NDC Directory).
Rhapsido NDC Codes and Packages
Each Rhapsido package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 00078-1483-20 | REMIBRUTINIB 25 mg/1 tablet | bottle of 60 tablets | Novartis Pharmaceuticals Corporation |
| 00078-1483-92 | REMIBRUTINIB 25 mg/1 tablet | carton of 2 bottles of 30 tablets | Novartis Pharmaceuticals Corporation |
| 00078-1483-93 | REMIBRUTINIB 25 mg/1 tablet | bottle of 30 tablets | Novartis Pharmaceuticals Corporation |
Source: the FDA NDC Directory, current listings only. Only packages sold under Rhapsido’s own FDA approval (NDA 218436) are listed, never a generic. Some codes belong to companies that repackage Rhapsido: it is the same medicine in a different package.
What a Generic Rhapsido Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Rhapsido as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Rhapsido”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Rhapsido
Is there a generic for Rhapsido right now?
No. As of October 9, 2026 no generic remibrutinib is listed for sale in the FDA NDC Directory.
When will Rhapsido go generic?
January 2043 is the expected month. It is when Rhapsido’s patent 12,419,889 ends. That patent covers a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic remibrutinib be the same as Rhapsido?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Rhapsido?
Not yet. The FDA Orange Book lists no approved generic version of Rhapsido.
When does the Rhapsido patent expire?
The FDA Orange Book lists 3 patents for Rhapsido; the last runs to January 2043. The one behind the expected month is patent 12,419,889, which ends in January 2043. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected month on this page (January 2043) weighs all of that.
How much does Rhapsido cost now?
Pharmacies paid about $72.46 per tablet for Rhapsido 25 mg tablet in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected January 2043 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- ExondysEteplirsenFebruary 2029
- TadliqTadalafil2030 to 2031
- OzempicSemaglutide2031 to 2032
- KynmobiApomorphine HydrochlorideApril 2036
- XipereTriamcinolone AcetonideApril 2040
- Belviq XRLorcaserin HydrochlorideTBD no date yet
About Rhapsido
- Generic name remibrutinib
- How it is taken By mouth
- Company Novartis Pharmaceuticals Corp
- More drugs Brand-name drugs starting with R
- Have a question? A pharmacist answers, free. Ask about Rhapsido
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.