Leustatin generics — when can they launch?
Leustatin (CLADRIBINE) · · 3 active US patents · 0 expired
Where Leustatin sits in the generic timeline
Long-dated protection: earliest active US patent for Leustatin extends to 2038 (~13 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 — 3 patents
FDA U-codes carved out by Leustatin 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-3411 | (no description) |
U-4395 | (no description) |
U-4399 | (no description) |
Sample patent estate
Showing 3 of 3 active US patents. View full estate on the Leustatin drug page →
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This patent protects a specific regimen of the drug Cladribine for treating progressive forms of multiple sclerosis, including primary and secondary progressive multiple sclerosis.USPTO title: Cladribine regimen for treating progressive forms of multiple sclerosis
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This patent protects a treatment regimen for the treatment of autoimmune disorders with an advantageous safety profile and/or a high quality of life for the patient.USPTO title: Treatment regimen for the treatment of autoimmune disorders
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This patent protects a treatment regimen for the treatment of autoimmune disorders with an advantageous safety profile and/or a high quality of life for the patient.USPTO title: Treatment regimen for the treatment of autoimmune disorders
Sources
- FDA Orange Book — patents listed against Leustatin (NDA filed 1993)
- Leustatin drug profile — full patent estate, indications, clinical trials, pricing
- 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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