Lytgobi generics — when can they launch?
Lytgobi (futibatinib) · Taiho Oncology · 6 active US patents · 0 expired
Where Lytgobi sits in the generic timeline
Long-dated protection: earliest active US patent for Lytgobi extends to 2033 (~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.
- Method of Use — 2 patents
- Composition of Matter — 2 patents
- Formulation — 2 patents
FDA U-codes carved out by Lytgobi 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-3456 | (no description) |
Sample patent estate
Showing 6 of 6 active US patents. View full estate on the Lytgobi drug page →
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This patent protects a compound represented by Formula (I) and its salts, as defined in the specification.USPTO title: 3,5-disubstituted alkynylbenzene compound and salt thereof
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This patent protects a compound represented by Formula (I) and its salts, as defined in the specification.USPTO title: 3,5-disubstituted alkynylbenzene compound and salt thereof
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This patent protects a crystal form of the compound (S)-1-(3-(4-amino-3-((3,5-dimethoxyphenyl)ethynyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)-1-pyrrolidinyl)-2-propen-1-one.USPTO title: Crystal of 3,5-disubstituted benzene alkynyl compound
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This patent protects a crystal form of the compound (S)-1-(3-(4-amino-3-((3,5-dimethoxyphenyl)ethynyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)-1-pyrrolidinyl)-2-propen-1-one.USPTO title: Crystal of 3,5-disubstituted benzene alkynyl compound
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This patent protects a pharmaceutical composition that combines the antitumor agent (S)-1-(3-(4-amino-3-((3,5-dimethoxyphenyl)ethynyl-1H-pyrazolo[3,4-d]pyrimidin-1-yl-1-pyrrolidinyl)-2-propen-1-one with sodium lauryl sulfate.USPTO title: Pharmaceutical composition including sodium alkyl sulfate
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This patent protects a pharmaceutical composition that combines the antitumor agent (S)-1-(3-(4-amino-3-((3,5-dimethoxyphenyl)ethynyl-1H-pyrazolo[3,4-d]pyrimidin-1-yl-1-pyrrolidinyl)-2-propen-1-one with sodium lauryl sulfate.USPTO title: Pharmaceutical composition including sodium alkyl sulfate
Sources
- FDA Orange Book — patents listed against Lytgobi (NDA filed 2022)
- Lytgobi drug profile — full patent estate, indications, clinical trials, pricing
- Taiho Oncology patent portfolio
- Patent cliff 2033 — 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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