Ojemda generics — when can they launch?
Ojemda (TOVORAFENIB) · Day One Biopharms · 4 active US patents · 0 expired
Where Ojemda sits in the generic timeline
Mid-term cliff: earliest active US patent for Ojemda expires in 2031 (~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.
- Composition of Matter — 2 patents
- Formulation — 2 patents
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the Ojemda drug page →
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This patent protects compounds that inhibit the Raf protein kinase and compositions and methods for treating diseases mediated by Raf.USPTO title: Compounds useful as Raf kinase inhibitors
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This patent protects compounds that inhibit the Raf protein kinase and compositions and methods for treating diseases mediated by Raf.USPTO title: Compounds useful as Raf kinase inhibitors
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This patent protects a pharmaceutical composition containing Compound 1 or a salt thereof for treating cancer and a process for its preparation.USPTO title: Pharmaceutical formulations of a pan-RAF kinase inhibitor and processes for their preparation
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This patent protects a pharmaceutical composition containing Compound 1 or a salt thereof for treating cancer and a process for its preparation.USPTO title: Pharmaceutical formulations of a pan-RAF kinase inhibitor and processes for their preparation
Sources
- FDA Orange Book — patents listed against Ojemda (NDA filed 2024)
- Ojemda drug profile — full patent estate, indications, clinical trials, pricing
- Day One Biopharms patent portfolio
- Patent cliff 2031 — 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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