Akynzeo Generic: When Will Generic Netupitant and Palonosetron 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
Akynzeo Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? September 2031 About 5 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 2037 22 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 netupitant and palonosetron hydrochloride is expected to be available in September 2031, about 5 years away. None is for sale yet. Each product has its own month below.
Why September 2031?
It is when Akynzeo’s patent 9,271,975 ends. That patent covers a way of using it, and once it ends, generics should be able to go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
If Akynzeo’s last patent runs to June 2037, how can a generic come sooner?
The 14 patents that run past the expected month, to June 2037 (8,426,450, 8,895,586, 9,403,772, 9,908,907 and 10 more), cover the active ingredient, the product’s formulation and a way of using it. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier date. Generic companies have been challenging Akynzeo’s patents with the FDA since April 2022. 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, 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 Akynzeo 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
- AkynzeoSeptember 2031Probable · patent expires
- for Injection2035 to 2036Probable · settlement between companies
Our month is only an estimate based on available information, so we never name a day.
Akynzeo 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
- $88M a yearSmaller seller, all 2 products
- FDA approved 2014 October 2014 FDA Orange Book
- Patents listed 22 last runs to June 2037 A generic is expected sooner, in September 2031. See why FDA Orange Book
- Medicare Part D spent $4.2M in 2025, for 1,022 people CMS Part D Spending by Drug
- Medicaid prescriptions 7,747 in the last four reported quarters, $5M CMS Medicaid drug utilization, to Q1 2026
Akynzeo’s Road to a Generic
Akynzeo has had the market to itself since the FDA approved it in October 2014 (Helsinn Healthcare SA). Its 22 listed patents run to June 2037. Generic companies have challenged its patents with the FDA since April 2022.
The first generic of Akynzeo is expected in September 2031.
Why that month: patent 9,271,975, on a way of using it, ends then. That is about 5.5 years before the last listed patent runs out, in June 2037.
Why a Generic Can Come Before June 2037
The last listed patent runs to June 2037; a court ruling or a settlement can bring a generic sooner. 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.
Akynzeo Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Akynzeo’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 9,271,975, which ends in September 2031, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,623,826 | A way of using it (U-2293) | November 2030 | Active |
| 8,951,969 | The product’s formulation | November 2030 | Active |
| 9,186,357 | A way of using it (U-2293, U-2301) | November 2030 | Active |
| 9,943,515 | A way of using it (U-2293) | November 2030 | Active |
| 11,559,523 | The product’s formulation; a way of using it (U-3522) | November 2030 | Active |
| 12,042,494 | The product’s formulation; a way of using it (U-3522) | November 2030 | Active |
| 10,828,297 | A way of using it (U-2293, U-2301) | December 2030 | Active |
| 9,271,975 Sets the expected month of generic availability | A way of using it (U-2293) | September 2031 | Active |
| 8,426,450 | The active ingredient; the product’s formulation | May 2032 | Active |
| 8,895,586 | A way of using it (U-2301) | May 2032 | Active |
| 9,403,772 | The active ingredient; a way of using it (U-2301) | May 2032 | Active |
| 9,908,907 | The active ingredient; the product’s formulation | May 2032 | Active |
| 10,208,073 | A way of using it (U-2301) | May 2032 | Active |
| 10,717,721 | The active ingredient | May 2032 | Active |
| 11,312,698 | The active ingredient; the product’s formulation | May 2032 | Active |
| 9,951,016 | The active ingredient; the product’s formulation | September 2035 | Active |
| 10,233,154 | The active ingredient | September 2035 | Active |
| 10,676,440 | The active ingredient; the product’s formulation | September 2035 | Active |
| 10,961,195 | The active ingredient; the product’s formulation | September 2035 | Active |
| 10,624,911 | The product’s formulation | June 2037 | Active |
| 11,529,362 | The product’s formulation | June 2037 | Active |
| 12,208,109 | The product’s formulation | June 2037 | Active |
Source: FDA Orange Book, application 205718, 210493. Patent numbers open the patent on Google Patents.
Patent Challenges to Akynzeo
The first patent challenge to Akynzeo reached the FDA in April 2022, from one company 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 Akynzeo’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 | |||||
| Solution in sdv, 235 mg/0.25 mg per 20 mL | April 2022 | 1 company | No decision yet | Not yet | Not yet | June 2037 |
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 Netupitant and Palonosetron Hydrochloride
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 Akynzeo yet.
Generic companies have challenged Akynzeo’s patents with the FDA since April 2022: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic netupitant and palonosetron hydrochloride. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic netupitant and palonosetron hydrochloride 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).
Akynzeo 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 Akynzeo, 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 Akynzeo
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 Akynzeo, before manufacturer rebates.
- $1.1M
- January to March 2026, the latest CMS has posted
For 464 people, about $1,061 per prescription fill - $4.2M
- 2025, the whole year
For 1,022 people, about $1,066 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $1,069,955 | 464 | $1,061.46 |
| 2025 | $4,234,465 | 1,022 | $1,066.08 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Akynzeo only, so no generic is counted in it. What CMS says it is used for: This product is a combination of 2 medications: fosnetupitant and palonosetron. It is used to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy).
Medicaid Prescriptions by Quarter
7,747 prescriptions in the four quarters to Q1 2026, $5M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 1,607 | $1,027,971 |
| Q4 2025 | 1,903 | $1,326,133 |
| Q3 2025 | 2,163 | $1,323,945 |
| Q2 2025 | 2,074 | $1,272,112 |
| Q1 2025 | 2,032 | $1,345,291 |
Source: CMS Medicaid State Drug Utilization Data, over Akynzeo’s own package codes.
Akynzeo Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 300MG;EQ 0.5MG BASE | Capsule | Oral | October 2014 | Prescription reference product |
| EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML) | Solution | Intravenous | May 2020 | Prescription reference product |
| EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL | Powder | Intravenous | April 2018 | Discontinued reference product |
Source: FDA Orange Book, Helsinn Healthcare SA. Listed for sale today by Helsinn Therapeutics (U.S.), Inc. (FDA NDC Directory).
Akynzeo NDC Codes and Packages
Each Akynzeo 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 |
|---|---|---|---|
| 69639-0102-01 | FOSNETUPITANT 260 mg/1 / PALONOSETRON HYDROCHLORIDE .28 mg/1 injection | vial of 1 injection | Helsinn Therapeutics (U.S.), Inc. |
| 69639-0102-01 | FOSNETUPITANT 260 mg/1 / PALONOSETRON HYDROCHLORIDE .28 mg/1 injection | vial of 1 injection | Helsinn Therapeutics (U.S.), Inc. |
| 69639-0105-01 | FOSNETUPITANT 260 mg/20mL / PALONOSETRON HYDROCHLORIDE .28 mg/20mL injection | vial of 20 mL | Helsinn Therapeutics (U.S.), Inc. |
| 69639-0105-01 | FOSNETUPITANT 260 mg/20mL / PALONOSETRON HYDROCHLORIDE .28 mg/20mL injection | vial of 20 mL | Helsinn Therapeutics (U.S.), Inc. |
| 69639-0106-01 | FOSNETUPITANT 260 mg/20mL / PALONOSETRON HYDROCHLORIDE .28 mg/20mL injection | vial of 20 mL | Helsinn Therapeutics (U.S.), Inc. |
| 69639-0106-01 | FOSNETUPITANT 260 mg/20mL / PALONOSETRON HYDROCHLORIDE .28 mg/20mL injection | vial of 20 mL | Helsinn Therapeutics (U.S.), Inc. |
| 69639-0101-01 | NETUPITANT 300 mg/1 / PALONOSETRON .5 mg/1 capsule | blister pack of 1 capsule | Helsinn Therapeutics (U.S.), Inc. |
| 69639-0101-01 | NETUPITANT 300 mg/1 / PALONOSETRON .5 mg/1 capsule | blister pack of 1 capsule | Helsinn Therapeutics (U.S.), Inc. |
| 69639-0101-04 | NETUPITANT 300 mg/1 / PALONOSETRON .5 mg/1 capsule | carton of 2 blister packs of 2 capsules | Helsinn Therapeutics (U.S.), Inc. |
| 69639-0101-04 | NETUPITANT 300 mg/1 / PALONOSETRON .5 mg/1 capsule | carton of 2 blister packs of 2 capsules | Helsinn Therapeutics (U.S.), Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Akynzeo’s own FDA approval (NDA 205718, NDA 210493) are listed, never a generic. Some codes belong to companies that repackage Akynzeo: it is the same medicine in a different package.
What a Generic Akynzeo Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Akynzeo 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 Akynzeo”. 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 Akynzeo
Is there a generic for Akynzeo right now?
No. As of October 9, 2026 no generic netupitant and palonosetron hydrochloride is listed for sale in the FDA NDC Directory.
When will Akynzeo go generic?
September 2031 is the expected month, and that is probable but not certain. It is when Akynzeo’s patent 9,271,975 ends. That patent covers a way of using it, and once it ends, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to June 2037; a court ruling or a settlement can bring a generic sooner.
Will generic netupitant and palonosetron hydrochloride be the same as Akynzeo?
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 Akynzeo?
Not yet. The FDA Orange Book lists no approved generic version of Akynzeo.
When does the Akynzeo patent expire?
The FDA Orange Book lists 22 patents for Akynzeo; the last runs to June 2037. The one behind the expected month is patent 9,271,975, which ends in September 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 (September 2031) weighs all of that.
Has anyone challenged the Akynzeo patents?
Yes. The first patent challenge to Akynzeo reached the FDA in April 2022, from one company 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 September 2031 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
- PlenvuAscorbic Acid, Polyethylene Glycol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, and Sodium Sulfate2028 to 2029
- TerlivazTerlipressin AcetateMarch 2030
- YcanthCantharidinJanuary 2031
- BrexafemmeIbrexafungerp Citrate2037 to 2039
- LitfuloRitlecitinib TosylateJune 2037
- Flonase Sensimist Allergy ReliefFluticasone FuroateTBD no date yet
About Akynzeo
- Generic name netupitant and palonosetron hydrochloride
- How it is taken By mouth
- Company Helsinn Healthcare SA
- Patent challenges Since April 2022 (FDA)
- More drugs Brand-name drugs starting with A
- Have a question? A pharmacist answers, free. Ask about Akynzeo
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.