Voranigo Generic: When Will Generic Vorasidenib 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
Voranigo Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? July 2038 About 12 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? January 2039 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 vorasidenib is expected to be available in July 2038, about 12 years away. None is for sale yet.
Why July 2038?
It is when Voranigo’s patent 9,579,324 ends. That patent covers the active ingredient, 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 Voranigo’s last patent runs to January 2039, how can a generic come sooner?
The patent that runs to January 2039 (11,345,677) covers 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 Voranigo 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.
Voranigo 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
- $31M a yearSmaller seller
- FDA approved 2024 August 2024 FDA Orange Book
- Patents listed 5 last runs to January 2039 A generic is expected sooner, in July 2038. See why FDA Orange Book
- Medicare Part D spent $157M in 2025, for 619 people CMS Part D Spending by Drug
- Medicaid prescriptions 1,947 in the last four reported quarters, $77.8M CMS Medicaid drug utilization, to Q1 2026
Voranigo’s Road to a Generic
Voranigo has had the market to itself since the FDA approved it in August 2024 (Servier Pharmaceuticals LLC). Its FDA protection (orphan drug) runs to August 2031. Its 5 listed patents run to January 2039.
The first generic of Voranigo is expected in July 2038.
Why that month: patent 9,579,324, on the active ingredient, ends then. That is a few months before the last listed patent runs out, in January 2039.
Why a Generic Can Come Before January 2039
The last listed patent runs to January 2039; 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.
Voranigo Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Voranigo’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 9,579,324, which ends in July 2034; the first generic is expected after it, in July 2038, about 12 years away. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,579,324 Sets the expected month of generic availability | The active ingredient | July 2034 | Active |
| 10,172,864 | The active ingredient; the product’s formulation | July 2034 | Active |
| 12,433,895 | A way of using it (U-4286) | July 2034 | Active |
| 11,844,758 | A way of using it (U-3977) | December 2035 | Active |
| 11,345,677 | The active ingredient; the product’s formulation; a way of using it (U-3978) | January 2039 | 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. | August 2029 | Active |
| Orphan drug ODE-491 | Seven years of protection for a use in a rare disease. | August 2031 | Active |
Source: FDA Orange Book, application 218784. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Vorasidenib
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 Voranigo yet.
Approved by the FDA
Not yet. The FDA has not approved a generic vorasidenib. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic vorasidenib 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).
Voranigo 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 Voranigo, 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 Voranigo
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 Voranigo, before manufacturer rebates.
- $54.8M
- January to March 2026, the latest CMS has posted
For 553 people, about $40,112 per prescription fill - $157M
- 2025, the whole year
For 619 people, about $38,802 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $54,753,084 | 553 | $40,112.15 |
| 2025 | $156,993,966 | 619 | $38,802.27 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Voranigo only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat certain types of brain tumors (astrocytoma, oligodendroglioma). Vorasidenib works by stopping or slowing the growth of tumor cells.
Medicaid Prescriptions by Quarter
1,947 prescriptions in the four quarters to Q1 2026, $77.8M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 558 | $22,480,952 |
| Q4 2025 | 556 | $22,218,938 |
| Q3 2025 | 453 | $18,017,577 |
| Q2 2025 | 380 | $15,117,753 |
| Q1 2025 | 274 | $10,906,045 |
Source: CMS Medicaid State Drug Utilization Data, over Voranigo’s own package codes.
Voranigo Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 10MG | Tablet | Oral | August 2024 | Prescription reference product |
| 40MG | Tablet | Oral | August 2024 | Prescription reference product |
Source: FDA Orange Book, Servier Pharmaceuticals LLC. Listed for sale today by Servier Pharmaceuticals LLC (FDA NDC Directory).
Voranigo NDC Codes and Packages
Each Voranigo 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 |
|---|---|---|---|
| 72694-0879-10 | VORASIDENIB 10 mg/1 tablet, film coated | bottle of 30 tablets | Servier Pharmaceuticals LLC |
| 72694-0728-40 | VORASIDENIB 40 mg/1 tablet, film coated | bottle of 30 tablets | Servier Pharmaceuticals LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Voranigo’s own FDA approval (NDA 218784) are listed, never a generic. Some codes belong to companies that repackage Voranigo: it is the same medicine in a different package.
What a Generic Voranigo Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Voranigo 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 Voranigo”. 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 Voranigo
Is there a generic for Voranigo right now?
No. As of October 9, 2026 no generic vorasidenib is listed for sale in the FDA NDC Directory.
When will Voranigo go generic?
July 2038 is the expected month, and that is probable but not certain. It is when Voranigo’s patent 9,579,324 ends. That patent covers the active ingredient, 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 January 2039; a court ruling or a settlement can bring a generic sooner.
Will generic vorasidenib be the same as Voranigo?
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 Voranigo?
Not yet. The FDA Orange Book lists no approved generic version of Voranigo.
When does the Voranigo patent expire?
The FDA Orange Book lists 5 patents for Voranigo; the last runs to January 2039. The one behind the expected month is patent 9,579,324, which ends in July 2034. 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 (July 2038) weighs all of that.
Changes to This Projection
- First generic expected July 2038 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
- QdoloTramadol Hydrochloride2027 to 2028
- Cardene IVNicardipine HydrochlorideDecember 2027
- TriptodurTriptorelin PamoateJune 2029
- ZeposiaOzanimod Hydrochloride2033 to 2034
- LynkuetElinzanetant2042 to 2043
- GilenyaFingolimod HydrochlorideTBD no date yet
About Voranigo
- Generic name vorasidenib
- How it is taken By mouth
- Company Servier Pharmaceuticals LLC
- More drugs Brand-name drugs starting with V
- Have a question? A pharmacist answers, free. Ask about Voranigo
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.