Scemblix Generic: When Will Generic Asciminib 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
Scemblix Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2035 to 2036 A wide window 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? May 2040 4 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 asciminib hydrochloride is expected to be available between 2035 and 2036. None is for sale yet.
Why 2035 to 2036?
No generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early. We rate it likely: firm enough to plan around, but a court ruling or a new deal could still move it.
If Scemblix’s last patent runs to May 2040, how can a generic come sooner?
The 3 patents that run past the expected month, to May 2040 (11,407,735, 12,252,478 and 12,252,479), cover the active ingredient, the product’s formulation and a way of using it. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier date. Generic companies have been challenging Scemblix’s patents with the FDA since November 2025. That is why the expected month comes before the last protection ends. See the road to a generic
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 Scemblix 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.
Scemblix by the Numbers
- Reason
- Not yet clearNo generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
- How sure
- Likely Firm enough to plan around, but a court ruling or a new deal could still move it.
- Price competition
- None filed yet No filers on record
- Brand sales
- $1.2B a yearBlockbuster
- FDA approved 2021 October 2021 FDA Orange Book
- Patents listed 4 last runs to May 2040 A generic is expected sooner, between 2035 and 2036. See why FDA Orange Book
- Medicare Part D spent $467.5M in 2025, for 3,267 people CMS Part D Spending by Drug
- Medicaid prescriptions 3,790 in the last four reported quarters, $89M CMS Medicaid drug utilization, to Q1 2026
Scemblix’s Road to a Generic
Scemblix has had the market to itself since the FDA approved it in October 2021 (Novartis Pharmaceuticals Corp). Its FDA protection (orphan drug) runs to October 2031. Its 4 listed patents run to May 2040. Generic companies have challenged its patents with the FDA since November 2025.
The first generic of Scemblix is expected between 2035 and 2036.
No generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
Why a Generic Can Come Before May 2040
The last listed patent runs to May 2040; a court ruling or a settlement can bring a generic sooner. 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.
Scemblix Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Scemblix’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 |
|---|---|---|---|
| 8,829,195 | The active ingredient; a way of using it (U-1374) | October 2035 | Active |
| 11,407,735 | The active ingredient | May 2040 | Active |
| 12,252,478 | The product’s formulation | May 2040 | Active |
| 12,252,479 | A way of using it (U-1374) | May 2040 | 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. | October 2026 | Active |
| New use I-953 | Three years of protection for a newly approved use (indication). | October 2027 | Active |
| New use I-954 | Three years of protection for a newly approved use (indication). | October 2027 | Active |
| New clinical information M-318 | Three years of protection for a change backed by new clinical studies. | October 2028 | Active |
| FDA exclusivity ODE* | A period of protection the FDA granted (code ODE*). | October 2028 | Active |
| Orphan drug ODE-381 | Seven years of protection for a use in a rare disease. | October 2028 | Active |
| Orphan drug ODE-382 | Seven years of protection for a use in a rare disease. | October 2028 | Active |
| Orphan drug ODE-499 | Seven years of protection for a use in a rare disease. | October 2031 | Active |
| Orphan drug ODE-500 | Seven years of protection for a use in a rare disease. | October 2031 | Active |
Source: FDA Orange Book, application 215358. Patent numbers open the patent on Google Patents.
Patent Challenges to Scemblix
The first patent challenge to Scemblix reached the FDA in November 2025, from 5 companies on that first day. The FDA’s list has 2 entries for Scemblix, by form and strength. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Scemblix’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 | |||||
| Tablets, 100 mg | November 2025 | 5 companies | No decision yet | Not yet | Not yet | May 2040 |
| Tablets, 20 mg and 40 mg | November 2025 | 6 companies | No decision yet | Not yet | Not yet | May 2040 |
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 Asciminib Hydrochloride
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 Scemblix yet.
Generic companies have challenged Scemblix’s patents with the FDA since November 2025: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic asciminib hydrochloride. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic asciminib hydrochloride 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).
Scemblix 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 Scemblix, 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 Scemblix
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 Scemblix, before manufacturer rebates.
- $164.6M
- January to March 2026, the latest CMS has posted
For 3,208 people, about $22,035 per prescription fill - $467.5M
- 2025, the whole year
For 3,267 people, about $22,471 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $164,579,077 | 3,208 | $22,034.95 |
| 2025 | $467,537,401 | 3,267 | $22,471.28 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Scemblix only, so no generic is counted in it. What CMS says it is used for: Asciminib is used to treat a certain type of cancer (chronic myeloid leukemia-CML). Asciminib belongs to a class of drugs known as kinase inhibitors.
Medicaid Prescriptions by Quarter
3,790 prescriptions in the four quarters to Q1 2026, $89M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 1,091 | $25,298,379 |
| Q4 2025 | 1,060 | $24,987,539 |
| Q3 2025 | 948 | $22,991,865 |
| Q2 2025 | 691 | $15,713,944 |
| Q1 2025 | 589 | $13,931,652 |
Source: CMS Medicaid State Drug Utilization Data, over Scemblix’s own package codes.
Scemblix Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 20MG BASE | Tablet | Oral | October 2021 | Prescription reference product |
| EQ 40MG BASE | Tablet | Oral | October 2021 | Prescription reference product |
| EQ 100MG BASE | Tablet | Oral | April 2024 | Prescription reference product |
Source: FDA Orange Book, Novartis Pharmaceuticals Corp. Listed for sale today by Novartis Pharmaceuticals Corporation (FDA NDC Directory).
Scemblix NDC Codes and Packages
Each Scemblix 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 |
|---|---|---|---|
| 00078-1196-20 | ASCIMINIB HYDROCHLORIDE 100 mg/1 tablet, film coated | bottle of 60 tablets | Novartis Pharmaceuticals Corporation |
| 00078-1091-20 | ASCIMINIB HYDROCHLORIDE 20 mg/1 tablet, film coated | bottle of 60 tablets | Novartis Pharmaceuticals Corporation |
| 00078-1091-20 | ASCIMINIB HYDROCHLORIDE 20 mg/1 tablet, film coated | bottle of 60 tablets | Novartis Pharmaceuticals Corporation |
| 00078-1091-94 | ASCIMINIB HYDROCHLORIDE 20 mg/1 tablet, film coated | bottle of 14 tablets | Novartis Pharmaceuticals Corporation |
| 00078-1091-94 | ASCIMINIB HYDROCHLORIDE 20 mg/1 tablet, film coated | bottle of 14 tablets | Novartis Pharmaceuticals Corporation |
| 00078-1098-20 | ASCIMINIB HYDROCHLORIDE 40 mg/1 tablet, film coated | bottle of 60 tablets | Novartis Pharmaceuticals Corporation |
| 00078-1098-20 | ASCIMINIB HYDROCHLORIDE 40 mg/1 tablet, film coated | bottle of 60 tablets | Novartis Pharmaceuticals Corporation |
| 00078-1098-30 | ASCIMINIB HYDROCHLORIDE 40 mg/1 tablet, film coated | carton of 5 bottles of 60 tablets | Novartis Pharmaceuticals Corporation |
| 00078-1098-94 | ASCIMINIB HYDROCHLORIDE 40 mg/1 tablet, film coated | bottle of 14 tablets | Novartis Pharmaceuticals Corporation |
| 00078-1098-94 | ASCIMINIB HYDROCHLORIDE 40 mg/1 tablet, film coated | bottle of 14 tablets | Novartis Pharmaceuticals Corporation |
Source: the FDA NDC Directory, current listings only. Only packages sold under Scemblix’s own FDA approval (NDA 215358) are listed, never a generic. Some codes belong to companies that repackage Scemblix: it is the same medicine in a different package.
What a Generic Scemblix Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Scemblix 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 Scemblix”. 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 Scemblix
Is there a generic for Scemblix right now?
No. As of October 9, 2026 no generic asciminib hydrochloride is listed for sale in the FDA NDC Directory.
When will Scemblix go generic?
2035 to 2036 is the expected window, and that is likely but not certain. No generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early. The last listed patent runs to May 2040; a court ruling or a settlement can bring a generic sooner.
Will generic asciminib hydrochloride be the same as Scemblix?
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 Scemblix?
Not yet. The FDA Orange Book lists no approved generic version of Scemblix.
When does the Scemblix patent expire?
The FDA Orange Book lists 4 patents for Scemblix; the last runs to May 2040. 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 (2035 to 2036) weighs all of that.
Has anyone challenged the Scemblix patents?
Yes. The first patent challenge to Scemblix reached the FDA in November 2025, from 5 companies on that first day. The FDA has not approved a first challenger’s generic 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 2035 to 2036 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
- BryhaliHalobetasol PropionateDuring 2026
- LivmarliMaralixibat ChlorideJanuary to June 2032
- YutrepiaTreprostinil SodiumMay 2037
- FocinvezFosaprepitant DimeglumineJanuary 2039
- PonvoryPonesimodOctober 2042
- TiglutikRiluzoleTBD no date yet
About Scemblix
- Generic name asciminib hydrochloride
- How it is taken By mouth
- Company Novartis Pharmaceuticals Corp
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since November 2025 (FDA)
- More drugs Brand-name drugs starting with S
- Have a question? A pharmacist answers, free. Ask about Scemblix
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.