Modeyso Generic: When Will Generic Dordaviprone 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
Modeyso Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? August 2039 About 13 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 2037 7 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic dordaviprone is expected to be available in August 2039, about 13 years away. None is for sale yet.
Why August 2039?
It is when Modeyso’s patent 10,172,862 ends. That patent covers a way of using it, and once it ends, 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. A company may already hold a “tentative” approval, which this record does not show.
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 Modeyso 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.
Modeyso 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 2025 August 2025 FDA Orange Book
- Patents listed 7 last runs to January 2037 FDA Orange Book
- Medicare Part D spent $3.2M in 2025, for 17 people CMS Part D Spending by Drug
- Medicaid prescriptions 35 in the last four reported quarters, $1.8M CMS Medicaid drug utilization, to Q4 2025
Modeyso’s Road to a Generic
Modeyso has had the market to itself since the FDA approved it in August 2025 (Chimerix Inc). Its FDA protection (orphan drug) runs to August 2032. Its 7 listed patents run to January 2037.
The first generic of Modeyso is expected in August 2039.
Why that month: patent 10,172,862, on a way of using it, ends 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.
Modeyso Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Modeyso’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 10,172,862, which ends in January 2037; the first generic is expected after it, in August 2039, about 13 years away.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,629,842 | A way of using it (U-4254) | April 2032 | Active |
| RE46290 | A way of using it (U-4254) | August 2032 | Active |
| 9,265,765 | The product’s formulation | July 2034 | Active |
| 11,976,068 | The product’s formulation | March 2036 | Active |
| 10,172,862 Sets the expected month of generic availability | A way of using it (U-4254) | January 2037 | Active |
| 10,369,154 | A way of using it (U-4254) | January 2037 | Active |
| 12,102,639 | A way of using it (U-4254) | January 2037 | 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 2030 | Active |
| Orphan drug ODE-547 | Seven years of protection for a use in a rare disease. | August 2032 | Active |
Source: FDA Orange Book, application 219876. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Dordaviprone
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 Modeyso yet.
Approved by the FDA
Not yet. The FDA has not approved a generic dordaviprone. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic dordaviprone for sale with the FDA.
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Modeyso 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 Modeyso, 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 Modeyso
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 Modeyso, before manufacturer rebates.
- $2.8M
- January to March 2026, the latest CMS has posted
For 20 people, about $57,060 per prescription fill - $3.2M
- 2025, the whole year
For 17 people, about $58,401 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $2,795,941 | 20 | $57,060.02 |
| 2025 | $3,212,073 | 17 | $58,401.33 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Modeyso 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 brain tumor (diffuse midline glioma). It works by slowing or stopping the growth of tumor cells.
Medicaid Prescriptions by Quarter
35 prescriptions in the four quarters to Q4 2025, $1.8M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q4 2025 | 35 | $1,788,512 |
| Q3 2025 | 0 | $0 |
Source: CMS Medicaid State Drug Utilization Data, over Modeyso’s own package codes.
Modeyso Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 125MG BASE | Capsule | Oral | August 2025 | Prescription reference product |
Source: FDA Orange Book, Chimerix Inc. Listed for sale today by Jazz Pharmaceuticals, Inc. (FDA NDC Directory).
Modeyso NDC Codes and Packages
Each Modeyso 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 |
|---|---|---|---|
| 68727-0250-01 | DORDAVIPRONE 125 mg/1 capsule | bottle of 10 capsules | Jazz Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Modeyso’s own FDA approval (NDA 219876) are listed, never a generic. Some codes belong to companies that repackage Modeyso: it is the same medicine in a different package.
What a Generic Modeyso Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Modeyso 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 Modeyso”. 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 Modeyso
Is there a generic for Modeyso right now?
No. As of October 9, 2026 no generic dordaviprone is listed for sale in the FDA NDC Directory.
When will Modeyso go generic?
August 2039 is the expected month, and that is probable but not certain. It is when Modeyso’s patent 10,172,862 ends. That patent covers a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic dordaviprone be the same as Modeyso?
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 Modeyso?
Not yet. The FDA Orange Book lists no approved generic version of Modeyso.
When does the Modeyso patent expire?
The FDA Orange Book lists 7 patents for Modeyso; the last runs to January 2037. The one behind the expected month is patent 10,172,862, which ends in January 2037. 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 (August 2039) weighs all of that.
Changes to This Projection
- First generic expected August 2039 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
- KaterziaAmlodipine Benzoate2029 to 2030
- OriahnnElagolix, Estradiol, and Norethindrone Acetate2035 to 2036
- WynzoraBetamethasone Dipropionate and CalcipotrieneMarch 2039
- SunlencaLenacapavir Sodium2041 to 2042
- AvaclyrAcyclovirTBD no date yet
- EpanedEnalapril MaleateTBD no date yet
About Modeyso
- Generic name dordaviprone
- How it is taken By mouth
- Company Chimerix Inc
- More drugs Brand-name drugs starting with M
- Have a question? A pharmacist answers, free. Ask about Modeyso
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, 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.