Onivyde Generic: When Will Generic Irinotecan 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
Onivyde Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? October 2036 About 10 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet
- When does the last patent end? October 2036 14 patents listed with the FDA
- Can you buy a generic today? Yes 16 companies list one
It already is. A generic irinotecan is listed for sale by 16 companies, so ask your pharmacy whether it can fill your prescription with one.
Why October 2036?
It is when Onivyde’s patents 9,339,497, 10,456,360, 10,993,914 and 12,059,497 end. They cover a way of using it and the product’s formulation, and once they end, 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.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Onivyde, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Onivyde 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
- $291M a yearBig seller
- FDA approved 2015 October 2015 FDA Orange Book
- Patents listed 14 last runs to October 2036 FDA Orange Book
- Medicare Part D spent $3.2M in 2025, for 70 people CMS Part D Spending by Drug
- Medicaid prescriptions 1,148 in the last four reported quarters, $4.6M CMS Medicaid drug utilization, to Q1 2026
Onivyde’s Road to a Generic
Onivyde has had the market to itself since the FDA approved it in October 2015 (Ipsen Biopharmaceuticals Inc). Its FDA protection (orphan drug) runs to February 2031. Its 14 listed patents run to October 2036.
The first generic of Onivyde is expected in October 2036.
Why that month: patents 9,339,497, 10,456,360, 10,993,914 and 12,059,497, on a way of using it and the product’s formulation, end 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.
Onivyde Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Onivyde’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: patents 9,339,497, 10,456,360, 10,993,914 and 12,059,497, which end in June 2033; the first generic is expected after it, in October 2036, about 10 years away.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,329,213 | The active ingredient; the product’s formulation | January 2027 | Active |
| 8,147,867 | The active ingredient; the product’s formulation | August 2028 | Active |
| 9,339,497 Sets the expected month of generic availability | A way of using it (U-1848) | June 2033 | Active |
| 9,364,473 | A way of using it (U-1856) | June 2033 | Active |
| 9,452,162 | A way of using it (U-1899) | June 2033 | Active |
| 9,492,442 | A way of using it (U-1917, U-1899, U-1848) | June 2033 | Active |
| 9,717,724 | A way of using it (U-2091, U-1848) | June 2033 | Active |
| 10,980,795 | A way of using it (U-1848) | June 2033 | Active |
| 11,369,597 | A way of using it (U-1848) | June 2033 | Active |
| 12,364,691 | A way of using it (U-1848) | June 2033 | Active |
| 11,344,552 | A way of using it (U-3824) | August 2036 | Active |
| 10,456,360 Sets the expected month of generic availability | The product’s formulation | October 2036 | Active |
| 10,993,914 Sets the expected month of generic availability | The product’s formulation | October 2036 | Active |
| 12,059,497 Sets the expected month of generic availability | The product’s formulation | October 2036 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New use I-932 | Three years of protection for a newly approved use (indication). | February 2027 | Active |
| Orphan drug ODE-463 | Seven years of protection for a use in a rare disease. | February 2031 | Active |
Source: FDA Orange Book, application 207793. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Irinotecan
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 Onivyde yet.
Approved by the FDA
Not yet. The FDA has not approved a generic irinotecan. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Yes. A generic irinotecan is listed for sale by 16 companies. Ask your pharmacy whether it can fill your prescription with it.
Actavis Pharma, Inc., Apotex Corp., Areva Pharmaceuticals,Inc., Areva Pharmaceuticals, Inc., Armas Pharmaceuticals Inc., AuroMedics Pharma LLC and 10 more
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).
Onivyde 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 Onivyde, 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 Onivyde
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 Onivyde, before manufacturer rebates.
- $874.8K
- January to March 2026, the latest CMS has posted
For 37 people, about $12,678 per prescription fill - $3.2M
- 2025, the whole year
For 70 people, about $14,215 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $874,812 | 37 | $12,678.43 |
| 2025 | $3,184,260 | 70 | $14,215.45 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Onivyde only, so no generic is counted in it. What CMS says it is used for: Irinotecan liposomal is used to treat cancer of the pancreas.
Medicaid Prescriptions by Quarter
1,148 prescriptions in the four quarters to Q1 2026, $4.6M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 263 | $1,063,025 |
| Q4 2025 | 247 | $847,025 |
| Q3 2025 | 280 | $1,087,932 |
| Q2 2025 | 358 | $1,622,119 |
| Q1 2025 | 398 | $1,708,509 |
Source: CMS Medicaid State Drug Utilization Data, over Onivyde’s own package codes.
Onivyde Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | Injectable, liposomal | Intravenous | October 2015 | Prescription reference product |
Source: FDA Orange Book, Ipsen Biopharmaceuticals Inc. Listed for sale today by Ipsen Biopharmaceuticals, Inc. (FDA NDC Directory).
Onivyde NDC Codes and Packages
Each Onivyde 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 |
|---|---|---|---|
| 15054-0043-01 | IRINOTECAN HYDROCHLORIDE 4.3 mg/mL injection, powder, for solution | vial of 10 mL | Ipsen Biopharmaceuticals, Inc. |
| 15054-0043-01 | IRINOTECAN HYDROCHLORIDE 4.3 mg/mL injection, powder, for solution | vial of 10 mL | Ipsen Biopharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Onivyde’s own FDA approval (NDA 207793) are listed, never a generic. Some codes belong to companies that repackage Onivyde: it is the same medicine in a different package.
What a Generic Onivyde Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
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.
Questions people ask about Onivyde
Is there a generic for Onivyde right now?
Yes. The FDA NDC Directory lists a generic irinotecan from 16 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Onivyde go generic?
It already has. The FDA NDC Directory lists a generic irinotecan from 16 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic irinotecan be the same as Onivyde?
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 Onivyde?
Not yet. The FDA Orange Book lists no approved generic version of Onivyde.
When does the Onivyde patent expire?
The FDA Orange Book lists 14 patents for Onivyde; the last runs to October 2036. The one behind the expected month is patents 9,339,497, 10,456,360, 10,993,914 and 12,059,497, which end in June 2033. 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 (October 2036) weighs all of that.
Changes to This Projection
- First generic expected October 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
- ZokinvyLonafarnibNovember 2027
- Tudorza PressairAclidinium BromideMarch 2029
- Quillichew ERMethylphenidate Hydrochloride2031 to 2032
- GlyxambiEmpagliflozin and Linagliptin2032 to 2033
- CibinqoAbrocitinibJanuary 2036
- MavyretGlecaprevir and PibrentasvirDecember 2036
About Onivyde
- Generic name irinotecan
- How it is taken Into a vein (IV)
- Company Ipsen Biopharmaceuticals Inc
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- More drugs Brand-name drugs starting with O
- Have a question? A pharmacist answers, free. Ask about Onivyde
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.