Akynzeo generics — when can they launch?
Akynzeo (NETUPITANT) · Helsinn Hlthcare · 12 active US patents · 0 expired
Where Akynzeo sits in the generic timeline
Mid-term cliff: earliest active US patent for Akynzeo expires in 2030 (~5 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Method of Use — 7 patents
- Composition of Matter — 4 patents
- Formulation — 1 patent
FDA U-codes carved out by Akynzeo patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-2293 | (no description) |
U-3522 | (no description) |
Sample patent estate
Showing 6 of 12 active US patents. View full estate on the Akynzeo drug page →
-
This patent protects compositions and methods for treating or preventing nausea and vomiting in patients undergoing chemotherapy, radiotherapy, or surgery.USPTO title: Compositions and methods for treating centrally mediated nausea and vomiting
-
This patent protects compositions and methods for treating or preventing nausea and vomiting in patients undergoing chemotherapy, radiotherapy, or surgery.USPTO title: Compositions and methods for treating centrally mediated nausea and vomiting
-
This patent protects compositions and methods for treating or preventing nausea and vomiting in patients undergoing chemotherapy, radiotherapy, or surgery.USPTO title: Compositions and methods for treating centrally mediated nausea and vomiting
-
This patent protects compositions and methods for treating or preventing nausea and vomiting in patients undergoing chemotherapy, radiotherapy, or surgery.USPTO title: Compositions and methods for treating centrally mediated nausea and vomiting
-
This patent protects compositions and methods for treating or preventing nausea and vomiting in patients undergoing chemotherapy, radiotherapy, or surgery.USPTO title: Compositions and methods for treating centrally mediated nausea and vomiting
-
This patent protects methods for treating nausea and vomiting in patients undergoing chemotherapy, radiotherapy, or surgery by co-administering netupitant, palonosetron, and dexamethasone.USPTO title: Compositions and methods for treating centrally mediated nausea and vomiting
Sources
- FDA Orange Book — patents listed against Akynzeo (NDA filed 2014)
- Akynzeo drug profile — full patent estate, indications, clinical trials, pricing
- Helsinn Hlthcare patent portfolio
- Patent cliff 2030 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
Get generic entry alerts
Free Pharma CI alerts on Akynzeo — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.
Subscribe free →