Marius Pharmaceuticals Receives Sixth U.S. Patent Allowance for KYZATREX® (TU) CIII Capsules Extending Coverage to 2040

madman

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Marius got this s**t on lock!

* This newly allowed patent provides additional protection for KYZATREX through 2040 and further underscores the unique formulation and delivery attributes that differentiate it from other testosterone replacement therapies.

* With six patents now protecting our therapy and more in progress, we are confident in our ability to remain insulated from generic disruption and compounding threats as KYZATREX becomes the go-to therapy option in this 25 million plus patient market.”





RALEIGH, N.C., May 28, 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) for a new patent related to its oral testosterone therapy, KYZATREX® (testosterone undecanoate) CIII Capsules. This is the sixth patent in the company’s growing intellectual property portfolio protecting KYZATREX.

This newly allowed patent provides additional protection for KYZATREX through 2040 and further underscores the unique formulation and delivery attributes that differentiate it from other testosterone replacement therapies. It reinforces the significant barriers to generic or compounded alternatives, and strengthens Marius Pharmaceuticals’ confidence in the durability of its proprietary, business model.

“This patent reinforces our commitment to evidence-based, precision treatment of testosterone deficiency,”
said Shalin Shah, CEO at Marius Pharmaceuticals. “By securing additional protection for KYZATREX, we continue to lead the way in oral testosterone innovation, making it easier for providers to deliver safe, effective care tailored to individual patient needs. With six patents now protecting our therapy and more in progress, we are confident in our ability to remain insulated from generic disruption and compounding threats as KYZATREX becomes the go-to therapy option in this 25 million plus patient market.”

The USPTO issues a Notice of Allowance when it determines that a patent application has met all formal requirements. This patent will extend protection for KYZATREX in the U.S. through 2040.


It adds to Marius’ robust global patent estate, which includes granted patents in the European Union, Canada, China, Taiwan, Japan, New Zealand, and other key markets, with pending applications in India and the U.S.
 

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Estradiol (E2)

A form of estrogen produced from testosterone. Important for bone health, mood, and libido. Too high can cause side effects; too low can affect well-being.

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Dihydrotestosterone is a potent androgen derived from testosterone. Affects hair growth, prostate health, and masculinization effects.

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The biologically active form of testosterone not bound to proteins. Directly available for cellular uptake and biological effects.

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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