Yondelis Generic: When Will Generic Trabectedin 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
Yondelis Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? July 2028 About a year and a half 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? July 2028 Its only patent listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic trabectedin is expected to be available in July 2028, about a year and a half away. None is for sale yet.
Why July 2028?
It is when Yondelis’s patent 8,895,557 ends. That patent covers 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. 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. 3 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic. See the price pattern
What should I do now?
Keep taking Yondelis 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.
Yondelis 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
- Moderate 3 companies have filed, 2 first in line
- Brand sales
- Sales not reported
- FDA approved 2015 October 2015 FDA Orange Book
- Patents listed 1 last runs to July 2028 FDA Orange Book
- Medicare Part D spent $1.1M in 2025, for 35 people CMS Part D Spending by Drug
- Medicaid prescriptions 614 in the last four reported quarters, $4M CMS Medicaid drug utilization, to Q4 2025
Yondelis’s Road to a Generic
Yondelis has had the market to itself since the FDA approved it in October 2015 (Janssen Products LP). Its one listed patent runs to July 2028. Generic companies have challenged its patents with the FDA since April 2020.
The first generic of Yondelis is expected in July 2028.
Why that month: patent 8,895,557, on 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.
Yondelis Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Yondelis’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 8,895,557, which ends in July 2028, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,895,557 Sets the expected month of generic availability | The product’s formulation | July 2028 with the pediatric extension | Active |
Source: FDA Orange Book, application 207953. Patent numbers open the patent on Google Patents.
Patent Challenges to Yondelis
The first patent challenge to Yondelis reached the FDA in April 2020, from 2 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 Yondelis’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 | |||||
| Powder for injection, 1 mg/vial | April 2020 | 2 companies | No decision yet | Not yet | Not yet | January 2028 |
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 Trabectedin
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
3 companies have applied to the FDA to make generic trabectedin.
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. 2 of them were first in line, both 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 Yondelis’s patents with the FDA since April 2020: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic trabectedin. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic trabectedin 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).
Yondelis 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 Yondelis, 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 Yondelis
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 Yondelis, before manufacturer rebates.
- $202.5K
- January to March 2026, the latest CMS has posted
About $8,099 per prescription fill - $1.1M
- 2025, the whole year
For 35 people, about $8,828 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $202,476 | – | $8,099.05 |
| 2025 | $1,147,646 | 35 | $8,828.04 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Yondelis only, so no generic is counted in it. What CMS says it is used for: Trabectedin is used to treat certain types of cancer. It is a chemotherapy drug that works by slowing the growth of cancer cells.
Medicaid Prescriptions by Quarter
614 prescriptions in the four quarters to Q4 2025, $4M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q4 2025 | 139 | $786,158 |
| Q3 2025 | 157 | $1,017,097 |
| Q2 2025 | 169 | $1,282,156 |
| Q1 2025 | 149 | $888,880 |
Source: CMS Medicaid State Drug Utilization Data, over Yondelis’s own package codes.
Yondelis Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 1MG/VIAL | Powder | Intravenous | October 2015 | Prescription reference product |
Source: FDA Orange Book, Janssen Products LP. Listed for sale today by Janssen Products, LP (FDA NDC Directory).
Yondelis NDC Codes and Packages
Each Yondelis 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 |
|---|---|---|---|
| 59676-0610-01 | TRABECTEDIN .05 mg/mL injection, powder, lyophilized, for solution | vial of 20 mL | Janssen Products, LP |
| 59676-0610-01 | TRABECTEDIN .05 mg/mL injection, powder, lyophilized, for solution | vial of 20 mL | Janssen Products, LP |
Source: the FDA NDC Directory, current listings only. Only packages sold under Yondelis’s own FDA approval (NDA 207953) are listed, never a generic. Some codes belong to companies that repackage Yondelis: it is the same medicine in a different package.
What a Generic Yondelis Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Yondelis 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 Yondelis”. 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 Yondelis
Is there a generic for Yondelis right now?
No. As of October 9, 2026 no generic trabectedin is listed for sale in the FDA NDC Directory.
When will Yondelis go generic?
July 2028 is the expected month, and that is probable but not certain. It is when Yondelis’s patent 8,895,557 ends. That patent covers the product’s formulation, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic trabectedin be the same as Yondelis?
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. 3 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Yondelis?
Not yet. The FDA Orange Book lists no approved generic version of Yondelis.
When does the Yondelis patent expire?
One patent is listed for Yondelis in the FDA Orange Book; it runs to July 2028, counting a six-month pediatric extension. The one behind the expected month is patent 8,895,557, which ends in July 2028. 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 2028) weighs all of that.
Has anyone challenged the Yondelis patents?
Yes. The first patent challenge to Yondelis reached the FDA in April 2020, from 2 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 July 2028 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
- Invokamet XRCanagliflozin and Metformin Hydrochloride2027 to 2028
- VictrelisBoceprevirNovember 2027
- SeglentisCelecoxib and Tramadol HydrochlorideApril 2030
- AlunbrigBrigatinibApril 2034
- Drizalma SprinkleDuloxetine HydrochlorideApril 2037
- Nurtec ODTRimegepant SulfateMarch 2039
About Yondelis
- Generic name trabectedin
- How it is taken Into a vein (IV)
- Company Janssen Products LP
- Patent challenges Since April 2020 (FDA)
- More drugs Brand-name drugs starting with Y
- Have a question? A pharmacist answers, free. Ask about Yondelis
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.