US Patent

US12011503 — Fixed dose oral testosterone undecanoate compositions and use thereof

Method of Use · Assigned to Lipocine Inc · Expires 2040-10-16 · 14y remaining

Vulnerability score 75/100 Vulnerable — likely target for IPR or design-around

What this patent protects

This patent protects fixed dose oral testosterone undecanoate compositions for use in testosterone replacement therapy regimens without dose titration.

USPTO Abstract

Disclosed are effective fixed dose oral testosterone undecanoate compositions for use in regimens without dose titration and methods for treatment of patients in need of testosterone replacement therapy. Also disclosed are criteria for continuation and discontinuation of such regimens, based on single serum T concentration levels measured at a steady state at predetermined times after initiation of said regimen and at a predetermined number of hours after administration of a morning dose of the regimen.

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-3964 — Aveed

Patent Metadata

Patent number
US12011503
Jurisdiction
US
Classification
Method of Use
Expires
2040-10-16
Drug substance claim
No
Drug product claim
Yes
Assignee
Lipocine 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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