ALECTINIB HYDROCHLORIDE generics — when can they launch?
ALECTINIB HYDROCHLORIDE (ALECTINIB HYDROCHLORIDE) · · 5 active US patents · 0 expired
Where ALECTINIB HYDROCHLORIDE sits in the generic timeline
Mid-term cliff: earliest active US patent for ALECTINIB HYDROCHLORIDE expires in 2030 (~4 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.
- Formulation — 4 patents
- Composition of Matter — 1 patent
Sample patent estate
Showing 5 of 5 active US patents. View full estate on the ALECTINIB HYDROCHLORIDE drug page →
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This patent protects a compound represented by Formula (I), useful as an ALK inhibitor for treating or preventing diseases like cancer.USPTO title: Tetracyclic compound
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This patent protects a compound represented by Formula (I), useful as an ALK inhibitor for treating or preventing diseases like cancer.USPTO title: Tetracyclic compound
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This patent protects a composition that includes a poorly water-soluble tetracyclic compound, a carrier, and a dissolution aid.USPTO title: Composition comprising tetracyclic compound
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This patent protects an improved solubility of a pharmaceutical composition containing a tetracyclic compound, achieved by forming granules of the compound with a disintegrating agent.USPTO title: Preparation containing tetracyclic compound at high dose
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This patent protects an improved solubility of a pharmaceutical composition containing a tetracyclic compound, achieved by forming granules of the compound with a disintegrating agent.USPTO title: Preparation containing tetracyclic compound at high dose
Sources
- FDA Orange Book — patents listed against ALECTINIB HYDROCHLORIDE (NDA filed 2015)
- ALECTINIB HYDROCHLORIDE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2030 — 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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