Lumakras generics — when can they launch?
Lumakras (SOTORASIB) · Amgen · 18 active US patents · 0 expired
Where Lumakras sits in the generic timeline
Long-dated protection: earliest active US patent for Lumakras extends to 2038 (~12 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 — 15 patents
- Composition of Matter — 3 patents
FDA U-codes carved out by Lumakras 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-4107 | (no description) |
U-3306 | (no description) |
Sample patent estate
Showing 6 of 18 active US patents. View full estate on the Lumakras drug page →
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This patent protects KRAS G12C inhibitors, their compositions, and methods of using them to treat various cancers, including pancreatic, colorectal, and lung cancers.USPTO title: KRAS G12C inhibitors and methods of using the same
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This patent protects KRAS G12C inhibitors, their compositions, and methods of using them to treat various cancers, including pancreatic, colorectal, and lung cancers.USPTO title: KRAS G12C inhibitors and methods of using the same
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This patent protects KRAS G12C inhibitors, their compositions, and methods of using them to treat various cancers, including pancreatic, colorectal, and lung cancers.USPTO title: KRAS G12C inhibitors and methods of using the same
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This patent protects a combination therapy that includes a KRASG12C inhibitor, such as Lumakras, and one or more additional active agents for treating cancers.USPTO title: Combination therapy including a KRASG12C inhibitor and one or more additional pharmaceutically active agents for the treatment of cancers
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This patent protects a combination therapy that includes a KRASG12C inhibitor, such as Lumakras, and one or more additional active agents for treating cancers.USPTO title: Combination therapy including a KRASG12C inhibitor and one or more additional pharmaceutically active agents for the treatment of cancers
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This patent protects a combination therapy that includes a KRASG12C inhibitor, such as Lumakras, and one or more additional active agents for treating cancers.USPTO title: Combination therapy including a KRASG12C inhibitor and one or more additional pharmaceutically active agents for the treatment of cancers
Sources
- FDA Orange Book — patents listed against Lumakras (NDA filed 2021)
- Lumakras drug profile — full patent estate, indications, clinical trials, pricing
- Amgen patent portfolio
- Patent cliff 2038 — 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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