FOSTAMATINIB DISODIUM generics — when can they launch?
FOSTAMATINIB DISODIUM (FOSTAMATINIB DISODIUM) · · 20 active US patents · 8 expired
Where FOSTAMATINIB DISODIUM sits in the generic timeline
All listed Orange Book patents for FOSTAMATINIB DISODIUM 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 — 10 patents
- Formulation — 8 patents
- Composition of Matter — 2 patents
FDA U-codes carved out by FOSTAMATINIB DISODIUM 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-2294 | (no description) |
Sample patent estate
Showing 6 of 20 active US patents. View full estate on the FOSTAMATINIB DISODIUM drug page →
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This patent protects prodrugs of 2,4-pyrimidinediamine compounds and their uses to inhibit cellular degranulation and treat associated diseases.USPTO title: Prodrugs of 2,4-pyrimidinediamine compounds and their uses
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This patent protects prodrugs of 2,4-pyrimidinediamine compounds and their uses to inhibit cellular degranulation and treat associated diseases.USPTO title: Prodrugs of 2,4-pyrimidinediamine compounds and their uses
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This patent protects prodrugs of biologically active 2,4-pyrimidinediamine compounds and their uses, including compositions and methods for synthesizing them.USPTO title: Prodrugs of 2,4-pyrimidinediamine compounds and their uses
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This patent protects prodrugs of biologically active 2,4-pyrimidinediamine compounds and their uses, including salts and hydrates.USPTO title: Prodrugs of 2,4-pyrimidinediamine compounds and their uses
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This patent protects prodrugs of biologically active 2,4-pyrimidinediamine compounds and their uses, including compositions and methods for synthesizing them.USPTO title: Prodrugs of 2,4-pyrimidinediamine compounds and their uses
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This patent protects prodrugs of biologically active 2,4-pyrimidinediamine compounds and their uses, including compositions and methods for synthesizing them.USPTO title: Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Sources
- FDA Orange Book — patents listed against FOSTAMATINIB DISODIUM (NDA filed 2018)
- FOSTAMATINIB DISODIUM 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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