FOSNETUPITANT CHLORIDE HYDROCHLORIDE generics — when can they launch?
FOSNETUPITANT CHLORIDE HYDROCHLORIDE (FOSNETUPITANT CHLORIDE HYDROCHLORIDE) · · 24 active US patents · 0 expired
Where FOSNETUPITANT CHLORIDE HYDROCHLORIDE sits in the generic timeline
Mid-term cliff: earliest active US patent for FOSNETUPITANT CHLORIDE HYDROCHLORIDE 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 — 10 patents
- Composition of Matter — 8 patents
- Formulation — 6 patents
FDA U-codes carved out by FOSNETUPITANT CHLORIDE HYDROCHLORIDE 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-2301 | (no description) |
Sample patent estate
Showing 6 of 24 active US patents. View full estate on the FOSNETUPITANT CHLORIDE HYDROCHLORIDE drug page →
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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
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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
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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
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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
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This patent protects compounds, compositions, and methods for preventing and/or treating diseases mediated by the neurokinin (NK1) receptor.USPTO title: Substituted piperaziniums for the treatment of emesis
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This patent protects compounds, compositions, and methods for preventing and/or treating diseases mediated by the neurokinin (NK1) receptor.USPTO title: Substituted 4-phenyl pyridines having anti-emetic effect
Sources
- FDA Orange Book — patents listed against FOSNETUPITANT CHLORIDE HYDROCHLORIDE (NDA filed 2018)
- FOSNETUPITANT CHLORIDE HYDROCHLORIDE drug profile — full patent estate, indications, clinical trials, pricing
- 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.
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