Duvyzat Generic: When Will Generic Givinostat 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
Duvyzat Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? May 2036 About 9.5 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? May 2040 5 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 givinostat hydrochloride is expected to be available in May 2036, about 9.5 years away. None is for sale yet.
Why May 2036?
It is when Duvyzat’s patent 9,421,184 ends. That patent covers a way of using it, 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 Duvyzat’s last patent runs to May 2040, how can a generic come sooner?
The 2 patents that run past the expected month, to May 2040 (10,688,047 and 12,606,519), cover the product’s formulation, a way of using it and the active ingredient. 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 Duvyzat 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.
Duvyzat 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
- Sales not reported
- FDA approved 2024 March 2024 FDA Orange Book
- Patents listed 5 last runs to May 2040 A generic is expected sooner, in May 2036. See why FDA Orange Book
- Medicare Part D spent $9.7M in 2025, for 31 people CMS Part D Spending by Drug
- Medicaid prescriptions 4,424 in the last four reported quarters, $227.7M CMS Medicaid drug utilization, to Q1 2026
Duvyzat’s Road to a Generic
Duvyzat has had the market to itself since the FDA approved it in March 2024 (Italfarmaco SpA). Its FDA protection (orphan drug) runs to March 2031. Its 5 listed patents run to May 2040.
The first generic of Duvyzat is expected in May 2036.
Why that month: patent 9,421,184, on a way of using it, ends then. That is about 4 years before the last listed patent runs out, in May 2040.
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.
Duvyzat Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Duvyzat’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 9,421,184, which ends in February 2032; the first generic is expected after it, in May 2036, about 9.5 years away. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 7,329,689 | The active ingredient; the product’s formulation | January 2027 | Active |
| 9,421,184 Sets the expected month of generic availability | A way of using it (U-3885) | February 2032 | Active |
| 9,867,799 | A way of using it (U-3885) | February 2032 | Active |
| 10,688,047 | The product’s formulation; a way of using it (U-3885) | October 2036 | Active |
| 12,606,519 | The active ingredient; the product’s formulation | 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. | March 2029 | Active |
| Orphan drug ODE-473 | Seven years of protection for a use in a rare disease. | March 2031 | Active |
Source: FDA Orange Book, application 217865. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Givinostat 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 Duvyzat yet.
Approved by the FDA
Not yet. The FDA has not approved a generic givinostat 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 givinostat 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).
Duvyzat 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 Duvyzat, 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 Duvyzat
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 Duvyzat, before manufacturer rebates.
- $4M
- January to March 2026, the latest CMS has posted
For 24 people, about $63,714 per prescription fill - $9.7M
- 2025, the whole year
For 31 people, about $58,934 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $4,013,963 | 24 | $63,713.71 |
| 2025 | $9,724,055 | 31 | $58,933.66 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Duvyzat only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat a certain inherited muscle disorder (Duchenne muscular dystrophy-DMD) that causes muscles to weaken. Givinostat may help slow down the worsening of muscle weakness.
Medicaid Prescriptions by Quarter
4,424 prescriptions in the four quarters to Q1 2026, $227.7M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 1,264 | $62,119,062 |
| Q4 2025 | 1,218 | $62,895,234 |
| Q3 2025 | 1,127 | $60,122,538 |
| Q2 2025 | 815 | $42,573,439 |
| Q1 2025 | 589 | $31,630,537 |
Source: CMS Medicaid State Drug Utilization Data, over Duvyzat’s own package codes.
Duvyzat Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 8.86MG BASE/ML | Suspension | Oral | March 2024 | Prescription reference product |
Source: FDA Orange Book, Italfarmaco SpA. Listed for sale today by Italfarmaco SPA (FDA NDC Directory).
Duvyzat NDC Codes and Packages
Each Duvyzat 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 |
|---|---|---|---|
| 11797-0110-02 | GIVINOSTAT 8.86 mg/mL suspension | bottle of 140 mL | Italfarmaco SPA |
Source: the FDA NDC Directory, current listings only. Only packages sold under Duvyzat’s own FDA approval (NDA 217865) are listed, never a generic. Some codes belong to companies that repackage Duvyzat: it is the same medicine in a different package.
What a Generic Duvyzat Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Duvyzat 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 Duvyzat”. 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 Duvyzat
Is there a generic for Duvyzat right now?
No. As of October 9, 2026 no generic givinostat hydrochloride is listed for sale in the FDA NDC Directory.
When will Duvyzat go generic?
May 2036 is the expected month, and that is probable but not certain. It is when Duvyzat’s patent 9,421,184 ends. That patent covers a way of using it, 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 May 2040; a court ruling or a settlement can bring a generic sooner.
Will generic givinostat hydrochloride be the same as Duvyzat?
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 Duvyzat?
Not yet. The FDA Orange Book lists no approved generic version of Duvyzat.
When does the Duvyzat patent expire?
The FDA Orange Book lists 5 patents for Duvyzat; the last runs to May 2040. The one behind the expected month is patent 9,421,184, which ends in February 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 (May 2036) weighs all of that.
Changes to This Projection
- First generic expected May 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
- CabometyxCabozantinib S-MalateJanuary 2031
- LupkynisVoclosporin2033 to 2034
- Pylarify TruvuPiflufolastat F 18June 2034
- ZelsuvmiBerdazimer Sodium2035 to 2036
- GalafoldMigalastat HydrochlorideJanuary 2037
- TrifericFerric Pyrophosphate CitrateTBD no date yet
About Duvyzat
- Generic name givinostat hydrochloride
- How it is taken By mouth
- Company Italfarmaco SpA
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- More drugs Brand-name drugs starting with D
- Have a question? A pharmacist answers, free. Ask about Duvyzat
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, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.