Dojolvi Generic: When Will Generic Triheptanoin 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
Dojolvi Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? During 2033 Sometime that year 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? November 2034 2 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 triheptanoin is expected to be available sometime in 2033. None is for sale yet.
Why 2033?
The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
If Dojolvi’s last patent runs to November 2034, how can a generic come sooner?
The patent that runs to November 2034 (12,551,461) covers the product’s formulation. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. Here, the companies are expected to settle on a date. Generic companies have been challenging Dojolvi’s patents with the FDA since July 2024. 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, and more so as more companies sell one. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic. See the price pattern
What should I do now?
Keep taking Dojolvi 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.
Dojolvi by the Numbers
- Reason
- Settlement expectedThe patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
- How sure
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- Strong 5 companies have filed, 3 first in line
- Brand sales
- $32M a yearSmaller seller
- FDA approved 2020 June 2020 FDA Orange Book
- Patents listed 2 last runs to November 2034 A generic is expected sooner, sometime in 2033. See why FDA Orange Book
- Medicare Part D spent $3.4M in 2025, for 23 people CMS Part D Spending by Drug
- Medicaid prescriptions 1,046 in the last four reported quarters, $16.6M CMS Medicaid drug utilization, to Q1 2026
Dojolvi’s Road to a Generic
Dojolvi has had the market to itself since the FDA approved it in June 2020 (Ultragenyx Pharmaceutical Inc). Its FDA protection (orphan drug) runs to June 2027. Its 2 listed patents run to November 2034. Generic companies have challenged its patents with the FDA since July 2024.
The first generic of Dojolvi is expected sometime in 2033.
Why that month: the patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
Why a Generic Can Come Before November 2034
The last listed patent runs to November 2034, but it covers the product’s formulation, not the medicine itself, which a generic can often work around or challenge. 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.
Dojolvi Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Dojolvi’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.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,697,748 | The product’s formulation | April 2029 | Active |
| 12,551,461 | The product’s formulation | November 2034 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| Orphan drug ODE-311 | Seven years of protection for a use in a rare disease. | June 2027 | Active |
Source: FDA Orange Book, application 213687. Patent numbers open the patent on Google Patents.
Patent Challenges to Dojolvi
The first patent challenge to Dojolvi reached the FDA in July 2024, from 3 companies on that first day. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Dojolvi’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Oral liquid, 100% w/w | July 2024 | 3 companies | No decision yet | Not yet | Not yet | April 2029 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Triheptanoin
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
5 companies have applied to the FDA to make generic triheptanoin.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for these yet, so the companies are not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
First in line. 3 of them were first in line, all filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Dojolvi’s patents with the FDA since July 2024: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic triheptanoin. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic triheptanoin 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).
Dojolvi 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 Dojolvi, 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 Dojolvi
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 Dojolvi, before manufacturer rebates.
- $866.7K
- January to March 2026, the latest CMS has posted
For 16 people, about $26,264 per prescription fill - $3.4M
- 2025, the whole year
For 23 people, about $21,652 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $866,706 | 16 | $26,263.81 |
| 2025 | $3,356,040 | 23 | $21,651.87 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Dojolvi only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat certain inherited disorders (long-chain fatty acid oxidation disorders- LC-FAOD). People with LC-FAOD cannot break down certain nutrients (fatty acids) to use as energy due to the lack of certain enzymes.
Medicaid Prescriptions by Quarter
1,046 prescriptions in the four quarters to Q1 2026, $16.6M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 281 | $4,595,028 |
| Q4 2025 | 241 | $3,858,249 |
| Q3 2025 | 260 | $4,064,451 |
| Q2 2025 | 264 | $4,060,319 |
| Q1 2025 | 252 | $4,004,008 |
Source: CMS Medicaid State Drug Utilization Data, over Dojolvi’s own package codes.
Dojolvi Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100% w/w | Liquid | Oral | June 2020 | Prescription reference product |
Source: FDA Orange Book, Ultragenyx Pharmaceutical Inc. Listed for sale today by Ultragenyx Pharmaceutical Inc. (FDA NDC Directory).
Dojolvi NDC Codes and Packages
Each Dojolvi 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 |
|---|---|---|---|
| 69794-0050-50 | TRIHEPTANOIN .96 g/mL liquid | bottle of 500 mL | Ultragenyx Pharmaceutical Inc. |
| 69794-0050-50 | TRIHEPTANOIN .96 g/mL liquid | bottle of 500 mL | Ultragenyx Pharmaceutical Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Dojolvi’s own FDA approval (NDA 213687) are listed, never a generic. Some codes belong to companies that repackage Dojolvi: it is the same medicine in a different package.
What a Generic Dojolvi Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Dojolvi 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 Dojolvi”. 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 Dojolvi
Is there a generic for Dojolvi right now?
No. As of October 9, 2026 no generic triheptanoin is listed for sale in the FDA NDC Directory.
When will Dojolvi go generic?
Sometime in 2033 is the expected window, and that is toss-up but not certain. The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. The last listed patent runs to November 2034, but it covers the product’s formulation, not the medicine itself, which a generic can often work around or challenge.
Will generic triheptanoin be the same as Dojolvi?
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. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Dojolvi?
Not yet. The FDA Orange Book lists no approved generic version of Dojolvi.
When does the Dojolvi patent expire?
The FDA Orange Book lists 2 patents for Dojolvi; the last runs to November 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 window on this page (Sometime in 2033) weighs all of that.
Has anyone challenged the Dojolvi patents?
Yes. The first patent challenge to Dojolvi reached the FDA in July 2024, from 3 companies on that first day. The FDA has not approved a first challenger’s generic yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
Changes to This Projection
- First generic expected Sometime in 2033 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
- YutiqFluocinolone AcetonideJanuary 2028
- LokelmaSodium Zirconium CyclosilicateDuring 2034
- BrukinsaZanubrutinib2036 to 2037
- FocinvezFosaprepitant DimeglumineJanuary 2039
- TlandoTestosterone UndecanoateApril 2041
- PrepopikCitric Acid, Magnesium Oxide, and Sodium PicosulfateTBD no date yet
About Dojolvi
- Generic name triheptanoin
- How it is taken By mouth
- Company Ultragenyx Pharmaceutical Inc
- Patent challenges Since July 2024 (FDA)
- More drugs Brand-name drugs starting with D
- Have a question? A pharmacist answers, free. Ask about Dojolvi
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, FDA Paragraph IV Patent Certifications list, 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.