Ztalmy Generic: When Will Generic Ganaxolone 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
Ztalmy Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? September 2042 About 16 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? September 2042 11 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic ganaxolone is expected to be available in September 2042, about 16 years away. None is for sale yet.
Why September 2042?
It is when Ztalmy’s patents 12,115,169 and 12,268,696 end. They cover a way of using it, and once they end, generics can go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
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 Ztalmy 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.
Ztalmy 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 2022 June 2022 FDA Orange Book
- Patents listed 11 last runs to September 2042 FDA Orange Book
- Medicare Part D spent $2.5M in 2025, for 12 people CMS Part D Spending by Drug
- Medicaid prescriptions 1,122 in the last four reported quarters, $19.5M CMS Medicaid drug utilization, to Q1 2026
Ztalmy’s Road to a Generic
Ztalmy has had the market to itself since the FDA approved it in June 2022 (Immedica Pharma AB). Its FDA protection (orphan drug) runs to June 2029. Its 11 listed patents run to September 2042.
The first generic of Ztalmy is expected in September 2042.
Why that month: patents 12,115,169 and 12,268,696, on a way of using it, end 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.
Ztalmy Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Ztalmy’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: patents 12,115,169 and 12,268,696, which end in September 2042, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 7,858,609 | The product’s formulation | November 2026 | Active |
| 8,022,054 | The product’s formulation | November 2026 | Active |
| 8,367,651 | The product’s formulation | November 2026 | Active |
| 8,618,087 | A way of using it (U-3374) | November 2026 | Active |
| 9,029,355 | The product’s formulation | November 2026 | Active |
| 9,056,116 | A way of using it (U-3374) | November 2026 | Active |
| 8,318,714 | The product’s formulation | November 2031 | Active |
| 10,603,308 | A way of using it (U-3374) | August 2037 | Active |
| 12,144,801 | A way of using it (U-4034) | August 2037 | Active |
| 12,115,169 Sets the expected month of generic availability | A way of using it (U-3374) | September 2042 | Active |
| 12,268,696 Sets the expected month of generic availability | A way of using it (U-3374) | September 2042 | 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. | June 2027 | Active |
| New dosing D-197 | Three years of protection for a new way of dosing it. | October 2028 | Active |
| Orphan drug ODE-395 | Seven years of protection for a use in a rare disease. | June 2029 | Active |
Source: FDA Orange Book, application 215904. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Ganaxolone
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 Ztalmy yet.
Approved by the FDA
Not yet. The FDA has not approved a generic ganaxolone. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic ganaxolone 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).
Ztalmy 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 Ztalmy, 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 Ztalmy
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 Ztalmy, before manufacturer rebates.
- $737.3K
- January to March 2026, the latest CMS has posted
For 11 people, about $23,042 per prescription fill - $2.5M
- 2025, the whole year
For 12 people, about $19,309 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $737,333 | 11 | $23,041.65 |
| 2025 | $2,490,905 | 12 | $19,309.34 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Ztalmy only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat seizures caused by a certain inherited disease (cyclin-dependent kinase-like 5 deficiency disorder-CDD). It is not known exactly how ganaxolone works, but it may affect the action of some nerves that cause seizures.
Medicaid Prescriptions by Quarter
1,122 prescriptions in the four quarters to Q1 2026, $19.5M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 296 | $5,506,173 |
| Q4 2025 | 280 | $4,884,903 |
| Q3 2025 | 337 | $5,497,769 |
| Q2 2025 | 209 | $3,649,884 |
| Q1 2025 | 264 | $4,440,943 |
Source: CMS Medicaid State Drug Utilization Data, over Ztalmy’s own package codes.
Ztalmy Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 50MG/ML | Suspension | Oral | June 2022 | Prescription reference product |
Source: FDA Orange Book, Immedica Pharma AB. Listed for sale today by Marinus Pharmaceuticals, Inc. and Immedica Pharma US Inc (FDA NDC Directory).
Ztalmy NDC Codes and Packages
Each Ztalmy 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 |
|---|---|---|---|
| 81583-0100-01 | GANAXOLONE 50 mg/mL suspension | bottle of 110 mL | Immedica Pharma US Inc |
| 81583-0100-01 | GANAXOLONE 50 mg/mL suspension | bottle of 110 mL | Immedica Pharma US Inc |
| 81583-0100-05 | GANAXOLONE 50 mg/mL suspension | carton of 5 bottles of 110 mL | Immedica Pharma US Inc |
Source: the FDA NDC Directory, current listings only. Only packages sold under Ztalmy’s own FDA approval (NDA 215904) are listed, never a generic. Some codes belong to companies that repackage Ztalmy: it is the same medicine in a different package.
What a Generic Ztalmy Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Ztalmy 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 Ztalmy”. 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 Ztalmy
Is there a generic for Ztalmy right now?
No. As of October 9, 2026 no generic ganaxolone is listed for sale in the FDA NDC Directory.
When will Ztalmy go generic?
September 2042 is the expected month, and that is probable but not certain. It is when Ztalmy’s patents 12,115,169 and 12,268,696 end. They cover a way of using it, and once they end, generics can go on sale as soon as the FDA approves them.
Will generic ganaxolone be the same as Ztalmy?
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 Ztalmy?
Not yet. The FDA Orange Book lists no approved generic version of Ztalmy.
When does the Ztalmy patent expire?
The FDA Orange Book lists 11 patents for Ztalmy; the last runs to September 2042. The one behind the expected month is patents 12,115,169 and 12,268,696, which end in September 2042. 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 (September 2042) weighs all of that.
Changes to This Projection
- First generic expected September 2042 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
- KerendiaFinerenoneAugust 2033
- OrilissaElagolix Sodium2034 to 2036
- WeliregBelzutifanAugust 2035
- AuvelityBupropion Hydrochloride and Dextromethorphan HydrobromideSeptember 2038
- EpinephrineEpinephrineMarch 2039
- SubsysFentanylTBD no date yet
About Ztalmy
- Generic name ganaxolone
- How it is taken By mouth
- Company Immedica Pharma AB
- More drugs Brand-name drugs starting with Z
- Have a question? A pharmacist answers, free. Ask about Ztalmy
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.