Ojemda Generic: When Will Generic Tovorafenib 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
Ojemda Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? August 2036 About 10 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? June 2035 2 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic tovorafenib is expected to be available in August 2036, about 10 years away. None is for sale yet.
Why August 2036?
It is when Ojemda’s patent 8,293,752 ends. That patent covers the active ingredient and the product’s formulation, 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 Ojemda 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.
Ojemda 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
- $173M a yearBig seller
- FDA approved 2024 April 2024 FDA Orange Book
- Patents listed 2 last runs to June 2035 FDA Orange Book
- Medicare Part D spent $5.7M in 2025, for 27 people CMS Part D Spending by Drug
- Medicaid prescriptions 706 in the last four reported quarters, $30.4M CMS Medicaid drug utilization, to Q1 2026
Ojemda’s Road to a Generic
Ojemda has had the market to itself since the FDA approved it in April 2024 (Day One Biopharmaceuticals Inc). Its FDA protection (orphan drug) runs to April 2031. Its 2 listed patents run to June 2035.
The first generic of Ojemda is expected in August 2036.
Why that month: patent 8,293,752, on the active ingredient and the product’s formulation, 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.
Ojemda Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Ojemda’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 8,293,752, which ends in August 2031; the first generic is expected after it, in August 2036, about 10 years away.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,293,752 Sets the expected month of generic availability | The active ingredient; the product’s formulation | August 2031 | Active |
| 10,426,782 | The product’s formulation | June 2035 | 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. | April 2029 | Active |
| Orphan drug ODE-478 | Seven years of protection for a use in a rare disease. | April 2031 | Active |
Source: FDA Orange Book, application 218033, 217700. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Tovorafenib
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 Ojemda yet.
Approved by the FDA
Not yet. The FDA has not approved a generic tovorafenib. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic tovorafenib 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).
Ojemda 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 Ojemda, 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 Ojemda
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 Ojemda, before manufacturer rebates.
- $1.9M
- January to March 2026, the latest CMS has posted
For 20 people, about $39,195 per prescription fill - $5.7M
- 2025, the whole year
For 27 people, about $37,503 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $1,881,356 | 20 | $39,194.91 |
| 2025 | $5,662,976 | 27 | $37,503.15 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Ojemda 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 (pediatric low-grade glioma). Tovorafenib belongs to a class of drugs known as kinase inhibitors.
Medicaid Prescriptions by Quarter
706 prescriptions in the four quarters to Q1 2026, $30.4M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 178 | $8,006,991 |
| Q4 2025 | 169 | $7,100,913 |
| Q3 2025 | 242 | $10,296,593 |
| Q2 2025 | 117 | $4,983,632 |
| Q1 2025 | 74 | $3,241,142 |
Source: CMS Medicaid State Drug Utilization Data, over Ojemda’s own package codes.
Ojemda Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100MG | Tablet | Oral | April 2024 | Prescription reference product |
| 25MG/ML | For suspension | Oral | April 2024 | Prescription reference product |
Source: FDA Orange Book, Day One Biopharmaceuticals Inc. Listed for sale today by Day One Biopharmaceuticals, Inc. (FDA NDC Directory).
Ojemda NDC Codes and Packages
Each Ojemda 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 |
|---|---|---|---|
| 82950-0001-16 | TOVORAFENIB 100 mg/1 tablet, film coated | carton of 4 blister packs of 4 tablets | Day One Biopharmaceuticals, Inc. |
| 82950-0001-20 | TOVORAFENIB 100 mg/1 tablet, film coated | carton of 4 blister packs of 5 tablets | Day One Biopharmaceuticals, Inc. |
| 82950-0001-24 | TOVORAFENIB 100 mg/1 tablet, film coated | carton of 4 blister packs of 6 tablets | Day One Biopharmaceuticals, Inc. |
| 82950-0012-01 | kit | 1 KIT in 1 CARTON * 12 mL in 1 BOTTLE, GLASS | Day One Biopharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Ojemda’s own FDA approval (NDA 218033, NDA 217700) are listed, never a generic. Some codes belong to companies that repackage Ojemda: it is the same medicine in a different package.
What a Generic Ojemda Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Ojemda 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 Ojemda”. 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 Ojemda
Is there a generic for Ojemda right now?
No. As of October 9, 2026 no generic tovorafenib is listed for sale in the FDA NDC Directory.
When will Ojemda go generic?
August 2036 is the expected month, and that is probable but not certain. It is when Ojemda’s patent 8,293,752 ends. That patent covers the active ingredient and the product’s formulation, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic tovorafenib be the same as Ojemda?
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 Ojemda?
Not yet. The FDA Orange Book lists no approved generic version of Ojemda.
When does the Ojemda patent expire?
The FDA Orange Book lists 2 patents for Ojemda; the last runs to June 2035. The one behind the expected month is patent 8,293,752, which ends in August 2031. 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 2036) weighs all of that.
Changes to This Projection
- First generic expected August 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
- LumifyBrimonidine TartrateJune 2027
- ZemdriPlazomicin SulfateJune 2032
- GanciclovirGanciclovirSeptember 2034
- Calcium Gluconate in Sodium ChlorideCalcium GluconateJuly 2037
- TrikaftaElexacaftor, Ivacaftor, and TezacaftorDecember 2037
- Purified CortrophinCorticotropinOctober 2043
About Ojemda
- Generic name tovorafenib
- How it is taken By mouth
- Company Day One Biopharmaceuticals Inc
- More drugs Brand-name drugs starting with O
- Have a question? A pharmacist answers, free. Ask about Ojemda
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.