LAZERTINIB MESYLATE generics — when can they launch?
LAZERTINIB MESYLATE (LAZERTINIB MESYLATE) · · 14 active US patents · 0 expired
Where LAZERTINIB MESYLATE sits in the generic timeline
Long-dated protection: earliest active US patent for LAZERTINIB MESYLATE extends to 2035 (~9 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 — 8 patents
- Formulation — 4 patents
- Composition of Matter — 2 patents
FDA U-codes carved out by LAZERTINIB MESYLATE 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-3985 | (no description) |
Sample patent estate
Showing 6 of 14 active US patents. View full estate on the LAZERTINIB MESYLATE drug page →
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This patent protects a group of protein kinase inhibitors, including aminopyrimidine derivatives and their pharmaceutically acceptable salts, for treating cell proliferative diseases and disorders.USPTO title: Compounds and compositions for modulating EGFR mutant kinase activities
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This patent protects a group of protein kinase inhibitors, including aminopyrimidine derivatives and their pharmaceutically acceptable salts, for treating cell proliferative diseases and disorders.USPTO title: Compounds and compositions for modulating EGFR mutant kinase activities
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This patent protects a novel mesylate salt of the compound N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1H-pyrazol-1-yl)pyrimidine-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide.USPTO title: Salt of an aminopyridine derivative compound, a crystalline form thereof, and a process for preparing the same
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This patent protects a pharmaceutical composition for oral administration that includes the active ingredient Lazertinib or its salt, combined with microcrystalline cellulose and mannitol.USPTO title: Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or its salt
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This patent protects a novel mesylate salt of a specific aminopyridine derivative compound and a process for preparing it.USPTO title: Salt of an aminopyridine derivative compound, a crystalline form thereof, and a process for preparing the same
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This patent protects a pharmaceutical composition for oral administration that includes the active ingredient Lazertinib or its salt, combined with microcrystalline cellulose and mannitol.USPTO title: Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or its salt
Sources
- FDA Orange Book — patents listed against LAZERTINIB MESYLATE (NDA filed 2024)
- LAZERTINIB MESYLATE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2035 — 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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