US11752129 — Formulations of apremilast
Method of Use · Assigned to Amgen Inc · Expires 2042-05-27 · 16y remaining
What this patent protects
This patent protects formulations of apremilast, specifically oral dosage forms that provide once-a-day dosing and are suitable for treating diseases or disorders ameliorated by inhibiting phosphodiesterase subtype IV.
USPTO Abstract
Provided herein are oral dosage forms comprising a) a core tablet comprising (i) a drug layer comprising apremilast and hypromellose acetate succinate (HPMCAS) in an amorphous solid dispersion; and (ii) a swellable layer comprising one or more swellable polymers; and b) a coating layer disposed on the core tablet, wherein the oral dosage form surface comprises at least one drug release orifice. The disclosed oral dosage forms provide once-a-day dosing of apremilast and are suitable for treating diseases or disorders ameliorated by inhibiting phosphodiesterase subtype IV (PDE4).
Drugs covered by this patent
- Otezla (APREMILAST) · Amgen
FDA Patent Use Codes
When a patent is method-of-use, FDA lists it once per applicable indication ("U-code"). Each U-code carves out a specific therapeutic use that generic filers must either license or design around.
| Code | Description | Drug |
|---|---|---|
U-4264 |
— | Otezla |
Bibliographic data sourced from FDA Orange Book + USPTO public records. Plain-English summary generated by AI grounded in source text. Patent term extensions (PTR, SPC, pediatric) may shift the effective expiry. Not legal advice.
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