Oxbryta generics — when can they launch?
Oxbryta (voxelotor) · Global Blood Theraps · 32 active US patents · 0 expired
Where Oxbryta sits in the generic timeline
Long-dated protection: earliest active US patent for Oxbryta extends to 2032 (~7 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
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.
- Composition of Matter — 12 patents
- Method of Use — 12 patents
- Formulation — 8 patents
FDA U-codes carved out by Oxbryta 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-2676 | (no description) |
U-3459 | (no description) |
U-3133 | (no description) |
U-3893 | (no description) |
Sample patent estate
Showing 6 of 32 active US patents. View full estate on the Oxbryta drug page →
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This patent protects substituted benzaldehyde compounds that act as allosteric modulators of hemoglobin, including the active substance Oxbryta.USPTO title: Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation
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This patent protects substituted benzaldehyde compounds that act as allosteric modulators of hemoglobin, including the active substance Oxbryta.USPTO title: Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation
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This patent protects substituted benzaldehydes and their derivatives that act as allosteric modulators of hemoglobin, including the active substance Oxbryta.USPTO title: Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation
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This patent protects substituted benzaldehydes and their derivatives that act as allosteric modulators of hemoglobin, including the active substance Oxbryta.USPTO title: Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation
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This patent protects substituted benzaldehyde compounds that act as allosteric modulators of hemoglobin, including the active substance Oxbryta.USPTO title: Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation
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This patent protects compounds and pharmaceutical compositions for modulating hemoglobin, including methods for their preparation and use in treating various disorders.USPTO title: Compounds and uses thereof for the modulation of hemoglobin
Sources
- FDA Orange Book — patents listed against Oxbryta (NDA filed 2019)
- Oxbryta drug profile — full patent estate, indications, clinical trials, pricing
- Global Blood Theraps patent portfolio
- Patent cliff 2032 — 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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