Rydapt Generic: When Will Generic Midostaurin 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
Rydapt Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2026 to 2027 A wide window Why then?
- Has the FDA approved a generic? April 2024 2 companies approved Why not on sale?
- When does the last patent end? December 2030 2 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic midostaurin is expected to be available between 2026 and 2027. None is for sale yet.
Why 2026 to 2027?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it probable: more likely than not, but it can still move.
If Rydapt’s last patent runs to December 2030, how can a generic come sooner?
The 2 patents that run past the expected month, to December 2030 (7,973,031 and 8,575,146), cover a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. Here, a settlement between the companies sets the date. Generic companies have been challenging Rydapt’s patents with the FDA since April 2021. That is why the expected month comes before the last protection ends. See the road to a generic
If the FDA approved a generic, why can’t I buy one?
FDA approval is permission to sell, not a launch. 2 companies have held approvals since April 2024, but a patent, a settlement or a company’s own plans can hold a generic back until the expected month. See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic. See the price pattern
What should I do now?
Keep taking Rydapt 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.
Rydapt by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Strong 5 companies have filed, 4 first in line
- Brand sales
- Sales not reported
- FDA approved 2017 April 2017 FDA Orange Book
- Patents listed 2 last runs to December 2030 A generic is expected sooner, between 2026 and 2027. See why FDA Orange Book
- Generics FDA-approved 2 companies, the first approved April 2024 FDA Orange Book
- Medicare Part D spent $31.3M in 2025, for 301 people CMS Part D Spending by Drug
- Medicaid prescriptions 56 in the last four reported quarters, $1.3M CMS Medicaid drug utilization, to Q1 2026
Rydapt’s Road to a Generic
Rydapt has had the market to itself since the FDA approved it in April 2017 (Novartis Pharmaceuticals Corp). Its 2 listed patents run to December 2030. Generic companies have challenged its patents with the FDA since April 2021.
The first generic of Rydapt is expected between 2026 and 2027.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Why a Generic Can Come Before December 2030
The last listed patent runs to December 2030, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
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.
Rydapt Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Rydapt’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.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 7,973,031 | A way of using it (U-2007) | October 2028 | Active |
| 8,575,146 | A way of using it (U-2008) | December 2030 | Active |
Source: FDA Orange Book, application 207997. Patent numbers open the patent on Google Patents.
Patent Challenges to Rydapt
The first patent challenge to Rydapt reached the FDA in April 2021, from 4 companies on that first day. The FDA approved a first challenger’s generic in April 2024, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Rydapt’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Capsules, 25 mg | April 2021 | 4 companies | First challenger eligible decided May 2024 | April 2024 | Not yet | December 2030 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Midostaurin
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
5 companies have applied to the FDA to make generic midostaurin.
The FDA has tentatively approved one company’s generic: Lotus Pharm Co Ltd (August 2022). A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
First in line. 4 of them were first in line, all filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Rydapt’s patents with the FDA since April 2021: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 2 companies, the first in April 2024. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Not yet. No company lists a generic midostaurin for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Lupin Inc | May 2024 | 25MG | AB |
| Dr Reddys Laboratories Ltd | June 2024 | 25MG | AB |
| Teva Pharmaceuticals Development Inc discontinued | April 2024 | 25MG | – |
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).
Rydapt Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Rydapt, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay 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).
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 Rydapt
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 Rydapt, before manufacturer rebates.
- $7.9M
- January to March 2026, the latest CMS has posted
For 140 people, about $24,419 per prescription fill - $31.3M
- 2025, the whole year
For 301 people, about $23,916 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $7,887,489 | 140 | $24,419.47 |
| 2025 | $31,329,719 | 301 | $23,915.82 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Rydapt only, so no generic is counted in it. What CMS says it is used for: Midostaurin is used to treat certain types of blood cell cancer (acute myeloid leukemia-AML, mast cell leukemia-MCL) or an immune system disorder (mastocytosis). It works by slowing or stopping the growth of cancer cells and certain immune system cells (mast cells).
Medicaid Prescriptions by Quarter
56 prescriptions in the four quarters to Q1 2026, $1.3M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 22 | $503,740 |
| Q4 2025 | 11 | $170,903 |
| Q3 2025 | 23 | $621,145 |
| Q2 2025 | 0 | $0 |
| Q1 2025 | 12 | $330,842 |
Source: CMS Medicaid State Drug Utilization Data, over Rydapt’s own package codes.
Rydapt Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 25MG | Capsule | Oral | April 2017 | Prescription reference product |
Source: FDA Orange Book, Novartis Pharmaceuticals Corp. Listed for sale today by Novartis Pharmaceuticals Corporation (FDA NDC Directory).
Rydapt NDC Codes and Packages
Each Rydapt 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 |
|---|---|---|---|
| 00078-0698-19 | MIDOSTAURIN 25 mg/1 capsule, liquid filled | carton of 4 cartons of 14 blister packs of 2 capsules | Novartis Pharmaceuticals Corporation |
| 00078-0698-19 | MIDOSTAURIN 25 mg/1 capsule, liquid filled | carton of 4 cartons of 14 blister packs of 2 capsules | Novartis Pharmaceuticals Corporation |
| 00078-0698-99 | MIDOSTAURIN 25 mg/1 capsule, liquid filled | carton of 2 cartons of 14 blister packs of 2 capsules | Novartis Pharmaceuticals Corporation |
| 00078-0698-99 | MIDOSTAURIN 25 mg/1 capsule, liquid filled | carton of 2 cartons of 14 blister packs of 2 capsules | Novartis Pharmaceuticals Corporation |
Source: the FDA NDC Directory, current listings only. Only packages sold under Rydapt’s own FDA approval (NDA 207997) are listed, never a generic. Some codes belong to companies that repackage Rydapt: it is the same medicine in a different package.
What a Generic Rydapt Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Rydapt 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 Rydapt”. 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 Rydapt
Is there a generic for Rydapt right now?
No. As of October 9, 2026 no generic midostaurin is listed for sale in the FDA NDC Directory. 3 generic versions are FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Rydapt go generic?
2026 to 2027 is the expected window, and that is probable but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. The last listed patent runs to December 2030, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic midostaurin be the same as Rydapt?
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. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Rydapt?
Yes. The FDA Orange Book lists approved generic versions from 2 companies, the first approved in April 2024: Lupin Inc and Dr Reddys Laboratories Ltd. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Rydapt patent expire?
The FDA Orange Book lists 2 patents for Rydapt; the last runs to December 2030. 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 window on this page (2026 to 2027) weighs all of that.
Has anyone challenged the Rydapt patents?
Yes. The first patent challenge to Rydapt reached the FDA in April 2021, from 4 companies on that first day. The FDA approved a first challenger’s generic in April 2024, and the list records no sale by a first challenger yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
Changes to This Projection
- First generic expected 2026 to 2027 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
- PifeltroDoravirineAugust 2032
- FinteplaFenfluramine HydrochlorideOctober to December 2033
- BrexafemmeIbrexafungerp Citrate2037 to 2039
- LilettaLevonorgestrelSeptember 2040
- YeztugoLenacapavir Sodium2041 to 2042
- TembexaBrincidofovirTBD no date yet
About Rydapt
- Generic name midostaurin
- How it is taken By mouth
- Company Novartis Pharmaceuticals Corp
- Patent challenges Since April 2021 (FDA)
- More drugs Brand-name drugs starting with R
- Have a question? A pharmacist answers, free. Ask about Rydapt
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, FDA Paragraph IV Patent Certifications list, 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.