US Patent

US12427136 — Formulations of apremilast

Method of Use · Assigned to Amgen Inc · Expires 2042-05-27 · 16y remaining

Vulnerability score 58/100 Moderate — design-around opportunities exist

What this patent protects

This patent protects oral dosage forms of apremilast 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

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.

CodeDescriptionDrug
U-1858 — Otezla

Patent Metadata

Patent number
US12427136
Jurisdiction
US
Classification
Method of Use
Expires
2042-05-27
Drug substance claim
No
Drug product claim
No
Assignee
Amgen Inc
Source
FDA Orange Book + USPTO grounding via Google Patents

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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