Prescription medicine
Fosnetupitant and palonosetron Brand names: Akynzeo
Fosnetupitant and palonosetron (Akynzeo) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: fosnetupitant and palonosetron labels on DailyMed; the NDA 210493 record on Drugs@FDA; every fosnetupitant and palonosetron label on DailyMed.
Highlights of the record
no current FDA label; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
The label in openFDA carries no indications section.
Forms and strengths
- 260 mg/20ml / 0.28 mg/20ml
Injection.
On the market
- Earliest approval on file
- April 19, 2018 Akynzeo, Helsinn Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 2, 2037 Akynzeo injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,137 through July 30, 2026
Is there a generic for fosnetupitant and palonosetron (Akynzeo)?
No generic fosnetupitant and palonosetron is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 12 patents for Akynzeo injection: the compound patent runs to May 23, 2032, and the last listed entry to June 2, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for fosnetupitant and palonosetron?
The FDA Adverse Event Reporting System holds 1,137 reports that list fosnetupitant and palonosetron among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 159 are coded as a death and 593 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other serotonin-3 receptor antagonists
- the pharmacologic class, with prices and generics
- Fosnetupitant and palonosetron side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other