CABOZANTINIB S-MALATE generics — when can they launch?
CABOZANTINIB S-MALATE (CABOZANTINIB S-MALATE) · · 46 active US patents · 0 expired
Where CABOZANTINIB S-MALATE sits in the generic timeline
All listed Orange Book patents for CABOZANTINIB S-MALATE have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
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 — 21 patents
- Formulation — 15 patents
- Composition of Matter — 10 patents
FDA U-codes carved out by CABOZANTINIB S-MALATE 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-4131 | (no description) |
U-4156 | (no description) |
U-1617 | (no description) |
U-3225 | (no description) |
U-1480 | (no description) |
U-2488 | (no description) |
U-1220 | (no description) |
Sample patent estate
Showing 6 of 46 active US patents. View full estate on the CABOZANTINIB S-MALATE drug page →
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This patent protects compounds, including quinazolines and quinolines, that inhibit or modulate certain kinase receptors, such as c-Met.USPTO title: c-Met modulators and methods of use
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This patent protects compounds, including quinazolines and quinolines, that inhibit or modulate certain kinase receptors, such as c-Met.USPTO title: c-Met modulators and methods of use
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This patent protects compounds, including quinazolines and quinolines, that inhibit or modulate certain kinase receptors, such as c-Met.USPTO title: c-Met modulators and methods of use
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This patent protects compounds, including quinazolines and quinolines, that inhibit or modulate certain kinase receptors, such as c-Met.USPTO title: c-Met modulators and methods of use
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This patent protects compounds, including quinazolines and quinolines, that inhibit or modulate certain kinase receptors, such as c-Met.USPTO title: c-Met modulators and methods of use
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This patent protects the malate salts of the cancer drug cabozantinib, including crystalline and amorphous forms, and methods of treating cancer with these salts.USPTO title: Malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-Nâ²-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide, and crystalline forms therof for the treatment of cancer
Sources
- FDA Orange Book — patents listed against CABOZANTINIB S-MALATE (NDA filed 2012)
- CABOZANTINIB S-MALATE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2026 — 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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