US9943527 — High-strength testosterone undecanoate compositions
Method of Use · Assigned to Lipocine Inc · Expires 2030-11-30 · 5y remaining
What this patent protects
This patent protects pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate.
USPTO Abstract
The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone C max to serum testosterone C ave of about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration C ave range for a male subject is provided.
Drugs covered by this patent
- Aveed (TESTOSTERONE UNDECANOATE) · Marius
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-1500 |
— | Aveed |
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.
Track this patent
Get a daily-checked alert when vulnerability score, expiry, classification, or assignee changes. Email, Slack, or Teams delivery. Pro: 50 watches, Free: 3.