Beleodaq generics — when can they launch?
Beleodaq (belinostat) · Acrotech Biopharma · 2 active US patents · 0 expired
Where Beleodaq sits in the generic timeline
All listed Orange Book patents for Beleodaq have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
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 — 1 patent
- Formulation — 1 patent
FDA U-codes carved out by Beleodaq 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-1544 | (no description) |
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the Beleodaq drug page →
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This patent protects a class of carbamic acid compounds that inhibit HDAC activity and have a specific chemical structure.USPTO title: Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors
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This patent protects pharmaceutical compositions containing certain carbamic acid compounds, such as PXD-101, in combination with ingredients like cyclodextrin, arginine, and meglumine.USPTO title: Pharmaceutical formulations of HDAC inhibitors
Sources
- FDA Orange Book — patents listed against Beleodaq (NDA filed 2014)
- Beleodaq drug profile — full patent estate, indications, clinical trials, pricing
- Acrotech Biopharma patent portfolio
- Patent cliff 2026 — 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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