Marius Pharmaceuticals Strengthens IP Portfolio with New KYZATREX® (testosterone undecanoate) CIII Capsules Formulation Patent

madman

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RALEIGH, N.C., March 25, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a new patent, strengthening the company’s intellectual property protection for its proprietary oral testosterone therapy, KYZATREX® (testosterone undecanoate) CIII Capsules.

This marks Marius Pharmaceuticals’ fifth U.S. patent, further reinforcing its leadership in the field of testosterone replacement therapy. The newly allowed patent specifically covers the company’s unique, novel formulation, which utilizes a self-emulsifying drug delivery system (SEDDS) incorporating phytosterol esters. This innovative technology enhances the bioavailability of oral testosterone, optimizing its absorption and effectiveness.

The USPTO issues a Notice of Allowance after determining that a patent application has met all necessary requirements, indicating that the patent will be granted upon payment of the issuance fee. This latest patent extends protection for KYZATREX® through 2033 and will be listed in the FDA’s Orange Book, further solidifying Marius Pharmaceuticals’ competitive position in the market.

This milestone supplements the company’s already robust global patent portfolio for KYZATREX®, which includes granted patents in the European Union, Canada, China, Taiwan, Japan, New Zealand, and other key markets, as well as pending applications in India and the U.S. Additionally, Marius Pharmaceuticals has multiple patent filings that could further extend protection beyond 2033, with the potential to reach 2040.
 
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Scientific Reference

Lakshman KM, Kaplan B, Travison TG, Basaria S, Knapp PE, Singh AB, LaValley MP, Mazer NA, Bhasin S. The effects of injected testosterone dose and age on the conversion of testosterone to estradiol and dihydrotestosterone in young and older men. J Clin Endocrinol Metab. 2010 Aug;95(8):3955-64.

DOI: 10.1210/jc.2010-0102 | PMID: 20534765 | PMCID: PMC2913038

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