Daurismo Generic: When Will Generic Glasdegib Be Available?

Dr. Brian Staiger, PharmD, BCPS

This page is aggregated from FDA records, court filings and company announcements. Coded and designed by

Updated October 9, 2026 How we build our data

Daurismo Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? November 2032 About 6 years away Why then?
  2. Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
  3. When does the last patent end? April 2036 5 patents listed with the FDA Why is a generic expected sooner?
  4. Can you buy a generic today? Not yet No company lists one for sale

Explains

PharmD, BCPS · Clinical pharmacist Updated

Generic glasdegib maleate is expected to be available in November 2032, about 6 years away. None is for sale yet.

Why November 2032?

It is when Daurismo’s patent 8,148,401 ends. That patent covers the active ingredient and the product’s formulation, and once it ends, generics should be able to go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.

If Daurismo’s last patent runs to April 2036, how can a generic come sooner?

The 3 patents that run past the expected month, to April 2036 (10,414,748, 11,168,066 and 11,891,372), 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. 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 Daurismo 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.

Daurismo by the Numbers

Reason
Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
How sure
Probable More likely than not, but it can still move.
Price competition
None filed yet No filers on record
Brand sales
$4M a yearSmaller seller
  • FDA approved 2018 November 2018 FDA Orange Book
  • Patents listed 5 last runs to April 2036 A generic is expected sooner, in November 2032. See why FDA Orange Book
  • Medicare Part D spent $3.2M in 2025, for 49 people CMS Part D Spending by Drug

Daurismo’s Road to a Generic

Daurismo has had the market to itself since the FDA approved it in November 2018 (Pfizer Inc). Its 5 listed patents run to April 2036.

The first generic of Daurismo is expected in November 2032.

Why that month: patent 8,148,401, on the active ingredient and the product’s formulation, ends then. That is about 3.5 years before the last listed patent runs out, in April 2036.

Brand alone on the market Since FDA approval, November 2018
Patent 8,431,597 Expires June 2028
Patent 8,148,401 Expires November 2032 The patent behind the expected month of generic availability
Patent 10,414,748 Expires April 2036
Patent 11,168,066 Expires April 2036
Patent 11,891,372 Expires April 2036
Brand alone on the market Patent on the active ingredient Patent on the formulation Patent on a use First generic expected Swipe the chart sideways to see every year.

Why a Generic Can Come Before April 2036

The last listed patent runs to April 2036; 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.

Daurismo Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Daurismo’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 8,148,401, which ends in November 2032, the month the first generic is expected. Why the later ones may not hold it back

Patents listed with the FDA (5)
PatentWhat it coversProtects untilStatus
8,431,597 The product’s formulation June 2028 Active
8,148,401 Sets the expected month of generic availability The active ingredient; the product’s formulation November 2032 Active
10,414,748 The active ingredient; the product’s formulation April 2036 Active
11,168,066 A way of using it (U-3254) April 2036 Active
11,891,372 A way of using it (U-3254) April 2036 Active

Source: FDA Orange Book, application 210656. Patent numbers open the patent on Google Patents.

Who Is Lined Up to Make Generic Glasdegib Maleate

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.

1

Applied to the FDA

No company is recorded as having applied to the FDA to make a generic Daurismo yet.

2

Approved by the FDA

Not yet. The FDA has not approved a generic glasdegib maleate. Final approval often comes close to the day a generic can be sold.

3

For Sale in Pharmacies

Not yet. No company lists a generic glasdegib maleate 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).

Daurismo 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 Daurismo, 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 Daurismo

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 Daurismo, before manufacturer rebates.

$894K
January to March 2026, the latest CMS has posted
For 21 people, about $23,526 per prescription fill
$3.2M
2025, the whole year
For 49 people, about $23,541 per prescription fill
See the numbers
PeriodSpendingPeoplePer fill
January to March 2026$893,97821$23,525.73
2025$3,201,55649$23,540.86

Source: CMS Medicare Part D Spending by Drug, matched by the brand name Daurismo only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat a certain type of cancer (acute myeloid leukemia-AML). It works by slowing or stopping the growth of cancer cells.

Daurismo Strengths and Forms

StrengthFormHow it is takenApprovedStatus
EQ 100MG BASETabletOralNovember 2018Prescription reference product
EQ 25MG BASETabletOralNovember 2018Prescription reference product

Source: FDA Orange Book, Pfizer Inc. Listed for sale today by Pfizer Laboratories Div Pfizer Inc (FDA NDC Directory).

Daurismo NDC Codes and Packages

Each Daurismo 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.

Daurismo packages (4)
NDCProductPackageCompany
00069-1531-30GLASDEGIB 100 mg/1 tablet, film coatedbottle of 30 tabletsPfizer Laboratories Div Pfizer Inc
00069-1531-30GLASDEGIB 100 mg/1 tablet, film coatedbottle of 30 tabletsPfizer Laboratories Div Pfizer Inc
00069-0298-60GLASDEGIB 25 mg/1 tablet, film coatedbottle of 60 tabletsPfizer Laboratories Div Pfizer Inc
00069-0298-60GLASDEGIB 25 mg/1 tablet, film coatedbottle of 60 tabletsPfizer Laboratories Div Pfizer Inc

Source: the FDA NDC Directory, current listings only. Only packages sold under Daurismo’s own FDA approval (NDA 210656) are listed, never a generic. Some codes belong to companies that repackage Daurismo: it is the same medicine in a different package.

What a Generic Daurismo Means for You

Nothing Changes Until It Is in Pharmacies

Until a generic is actually for sale, keep filling Daurismo 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 Daurismo”. 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 Daurismo

Is there a generic for Daurismo right now?

No. As of October 9, 2026 no generic glasdegib maleate is listed for sale in the FDA NDC Directory.

When will Daurismo go generic?

November 2032 is the expected month, and that is probable but not certain. It is when Daurismo’s patent 8,148,401 ends. That patent covers the active ingredient and the product’s formulation, and once it ends, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to April 2036; a court ruling or a settlement can bring a generic sooner.

Will generic glasdegib maleate be the same as Daurismo?

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 Daurismo?

Not yet. The FDA Orange Book lists no approved generic version of Daurismo.

When does the Daurismo patent expire?

The FDA Orange Book lists 5 patents for Daurismo; the last runs to April 2036. The one behind the expected month is patent 8,148,401, which ends in November 2032. 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 (November 2032) weighs all of that.

Changes to This Projection

  • First generic expected November 2032 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

All upcoming generics

About Daurismo

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, CMS Medicare Part D Spending by Drug, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.