Lutetium Lu 177 Dotatate generics — when can they launch?
Lutetium Lu 177 Dotatate (Lutetium Lu 177 Dotatate) · National Cancer Institute (NCI) · 18 active US patents · 0 expired
Where Lutetium Lu 177 Dotatate sits in the generic timeline
Long-dated protection: earliest active US patent for Lutetium Lu 177 Dotatate 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.
- Other — 9 patents
- Method of Use — 6 patents
- Formulation — 3 patents
FDA U-codes carved out by Lutetium Lu 177 Dotatate 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-4036 | (no description) |
Sample patent estate
Showing 6 of 18 active US patents. View full estate on the Lutetium Lu 177 Dotatate drug page →
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This patent protects a method for creating stable, concentrated solutions of radionuclide complexes suitable for use as a drug product.USPTO title: Stable, concentrated radionuclide complex solutions
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This patent protects a method for creating stable, concentrated solutions of radionuclide complexes suitable for use as a drug product.USPTO title: Stable, concentrated radionuclide complex solutions
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This patent protects a method for creating stable, concentrated solutions of radionuclide complexes suitable for use as a drug product.USPTO title: Stable, concentrated radionuclide complex solutions
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This patent protects a method of using a radionuclide complex solution, specifically Lutetium Lu 177 Dotatate, with added stabilizers to prevent degradation.USPTO title: Stable, concentrated radionuclide complex solutions
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This patent protects a method of using a radionuclide complex solution, specifically Lutetium Lu 177 Dotatate, with added stabilizers to prevent degradation.USPTO title: Stable, concentrated radionuclide complex solutions
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This patent protects a method of using a radionuclide complex solution, specifically Lutetium Lu 177 Dotatate, with added stabilizers to prevent degradation.USPTO title: Stable, concentrated radionuclide complex solutions
Sources
- FDA Orange Book — patents listed against Lutetium Lu 177 Dotatate (NDA)
- Lutetium Lu 177 Dotatate drug profile — full patent estate, indications, clinical trials, pricing
- National Cancer Institute (NCI) 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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