Lipocine. has filed a patent for a steroid-containing oral pharmaceutical composition comprising testosterone undecanoate, hydrophilic and lipophilic surfactants, and a solidifying agent. The composition aims to provide safe and effective testosterone levels over time for treating deficiencies in individuals. GlobalData’s report on Lipocine gives a 360-degree view of the company including its patenting strategy. Buy the report here.
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According to GlobalData’s company profile on Lipocine, Nanoparticle drug conjugates was a key innovation area identified from patents. Lipocine's grant share as of January 2024 was 47%. Grant share is based on the ratio of number of grants to total number of patents.
Oral pharmaceutical composition for testosterone deficiency treatment
A newly filed patent (Publication Number: US20240009206A1) discloses an oral pharmaceutical composition containing testosterone undecanoate in a range of greater than 20% w/w to 25% w/w. The composition also includes a hydrophilic surfactant carrier, a solidifying agent comprising no more than 20% w/w, and a lipophilic surfactant carrier comprising fatty acids or fatty acid esters. The pharmaceutical composition is designed to contain between 70 mg to 150 mg of testosterone undecanoate and have a predetermined viscosity. Additionally, the composition may include additives such as solids, liquids, or semi-solids, and may also contain phytosterols or esters thereof.
Furthermore, the patent claims that when this composition is orally administered as a unit dosage form twice daily with a meal to a hypogonadal male, it results in a plasma Cmax of testosterone of less than 2500 ng/dL. The steady-state plasma testosterone concentration in the hypogonadal male is expected to be in the range of about 250 ng/dL to 1200 ng/dL. The lipophilic surfactant carrier may include glycerol palmitostearate or glyceryl monolinoleate, and the composition may contain testosterone undecanoate in varying amounts ranging from about 8 mg to 140 mg. One specific claim mentions a composition comprising 25% w/w of testosterone undecanoate. These claims highlight the specific formulation and dosing regimen of the oral pharmaceutical composition for treating hypogonadism in males.
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GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies
