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KYZATREX Drug Patent Profile

When do Kyzatrex patents expire, and what generic alternatives are available?

Kyzatrex is a drug marketed by Marius Pharms Llc and is included in one NDA. There are four patents protecting this drug.

This drug has twenty patent family members in eleven countries.

The generic ingredient in KYZATREX is testosterone undecanoate. There are sixty-nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Kyzatrex

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 27, 2025. This may change due to patent challenges or generic licensing.

There is one tentative approval for the generic drug (testosterone undecanoate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for KYZATREX

International Patents:	20
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	1
Patent Applications:	1,479
Drug Prices:	Drug price information for KYZATREX
What excipients (inactive ingredients) are in KYZATREX?	KYZATREX excipients list
DailyMed Link:	KYZATREX at DailyMed

See drug prices for KYZATREX

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for KYZATREX

Constraining patent/regulatory exclusivity:

NEW PRODUCT

NDA:

213953

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for KYZATREX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
San Diego Sexual Medicine	Phase 2

See all KYZATREX clinical trials

Pharmacology for KYZATREX

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

US Patents and Regulatory Information for KYZATREX

KYZATREX is protected by four US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PRODUCT.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Marius Pharms Llc	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-001	Jul 27, 2022		RX	Yes	No			Y
Marius Pharms Llc	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-002	Jul 27, 2022		RX	Yes	No			Y
Marius Pharms Llc	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-001	Jul 27, 2022		RX	Yes	No			Y
Marius Pharms Llc	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-003	Jul 27, 2022		RX	Yes	Yes			Y

International Patents for KYZATREX

See the table below for patents covering KYZATREX around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	I673068
European Patent Office	2519230	MODULATION DE LA SOLUBILITÉ, DE LA STABILITÉ, DE L'ABSORPTION, DU MÉTABOLISME ET DU PROFIL PHARMACOCINÉTIQUE DE MÉDICAMENTS LIPOPHILES PAR LES STÉROLS (MODULATION OF SOLUBILITY, STABILITY, ABSORPTION, METABOLISM, AND PHARMACOKINETIC PROFILE OF LIPOPHILIC DRUGS BY STEROLS)
Japan	5836322
Hong Kong	1219061	乳液製劑 (EMULSION FORMULATIONS)

KYZATREX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for KYZATREX

Introduction to KYZATREX

KYZATREX, developed by Marius Pharmaceuticals, is an oral testosterone replacement therapy (TRT) approved by the U.S. Food and Drug Administration (FDA) for treating conditions associated with a deficiency or absence of endogenous testosterone, commonly known as hypogonadism[3].

Market Need and Demand

Prevalence of Hypogonadism

Hypogonadism affects a significant portion of the male population, with approximately 40% of men older than 45 years and 30-50% of men with obesity or type 2 diabetes suffering from this condition. This widespread prevalence creates a substantial market demand for effective TRT options[3].

Competitive Landscape

The testosterone replacement therapy market is diverse, with various product types such as injectables, gels, patches, and now oral formulations like KYZATREX. The injectable segment currently dominates the market, but oral formulations are expected to grow significantly due to their convenience and patient preference[1].

Product Differentiation and Advantages

Unique Formulation

KYZATREX is distinguished by its proprietary softgel oral formulation, which is absorbed primarily via the lymphatic system, avoiding liver toxicity. This formulation utilizes phytosterols, a first in pharmaceutical products, to ensure safe and effective oral testosterone delivery[3][4].

Clinical Efficacy

Clinical trials have demonstrated the efficacy of KYZATREX in restoring normal testosterone levels. Up to 96% of patients achieved normal testosterone levels by Day 90, and the treatment also showed improvements in quality of life, energy, erectile function, and mood[3][4].

Market Dynamics

Regional Growth

The global testosterone replacement therapy market is expected to grow, with North America currently holding a major share due to the strong presence of key players and well-developed healthcare infrastructure. However, the Asia-Pacific region is anticipated to register the highest CAGR during the forecast period due to the rising incidence of hypogonadism and unhealthy lifestyles[1].

End User Segment

Clinics are the dominant end users in the TRT market, and this segment is expected to register the fastest growth during the forecast period. This growth is driven by the increasing number of patients seeking treatment for hypogonadism in clinical settings[1].

Financial Trajectory

Approval and Launch Impact

The FDA approval of KYZATREX in 2022 marked a significant milestone for Marius Pharmaceuticals. The commercial launch of KYZATREX is expected to contribute substantially to the company's revenue, given the large patient population suffering from hypogonadism and the lack of convenient oral TRT options[3].

Revenue Projections

While specific revenue projections for KYZATREX are not detailed in the available sources, the overall testosterone replacement therapy market is projected to grow from $1.9 billion in 2022 to $2.9 billion by 2032, with a CAGR that indicates strong market growth. The oral segment, where KYZATREX operates, is expected to register a high CAGR during this period[1].

Industry Trends and Innovations

The success of KYZATREX is part of a broader trend in the pharmaceutical industry towards innovative delivery systems and patient-centric treatments. Companies like Marius Pharmaceuticals are investing heavily in research and development to bring new and effective treatments to market, which is expected to drive financial growth and market expansion[3][4].

Competitive Analysis and Market Positioning

Market Positioning

KYZATREX is positioned as a convenient and effective oral TRT option, addressing the needs of patients who prefer oral medications over injectables or other forms of delivery. This positioning is crucial in capturing a significant share of the growing TRT market[3].

Competitive Advantage

The unique formulation and clinical efficacy of KYZATREX provide a competitive advantage over other TRT products. The safety profile, including the avoidance of liver toxicity, and the improvements in quality of life and metabolic factors further enhance its market appeal[3][4].

Future Outlook

Expansion and Research

Marius Pharmaceuticals plans to continue researching the importance of testosterone in male and female health, potentially expanding the use of KYZATREX beyond its current indications. This ongoing research and development are expected to further solidify KYZATREX's position in the market and drive future growth[3][4].

Market Penetration

With the FDA approval and positive clinical data, KYZATREX is poised to become a leading therapy in the TRT market. The company's commercial efforts, including marketing and distribution strategies, will be crucial in achieving widespread market penetration and maximizing revenue potential[3].

Key Takeaways

• Market Demand: Hypogonadism affects a significant portion of the male population, creating a substantial market demand for effective TRT options.
• Product Differentiation: KYZATREX's unique oral formulation and clinical efficacy set it apart in the market.
• Regional Growth: The Asia-Pacific region is expected to register the highest CAGR in the TRT market.
• Financial Trajectory: The overall TRT market is projected to grow significantly, with KYZATREX expected to contribute substantially to Marius Pharmaceuticals' revenue.
• Competitive Advantage: KYZATREX's safety profile, convenience, and clinical efficacy provide a competitive edge.

FAQs

What is KYZATREX used for?

KYZATREX is an oral testosterone replacement therapy used to treat adult males with conditions associated with a deficiency or absence of endogenous testosterone, known as hypogonadism[3].

How is KYZATREX different from other TRT products?

KYZATREX is distinguished by its proprietary softgel oral formulation, which is absorbed via the lymphatic system, avoiding liver toxicity. It also utilizes phytosterols, a first in pharmaceutical products[3][4].

What are the clinical efficacy results of KYZATREX?

Clinical trials have shown that KYZATREX is up to 96% effective in restoring normal testosterone levels by Day 90 and improves quality of life, energy, erectile function, and mood[3][4].

What is the market outlook for KYZATREX?

The market outlook is positive, with the Asia-Pacific region expected to register the highest CAGR in the TRT market. KYZATREX is poised to capture a significant share due to its unique formulation and clinical efficacy[1][3].

What are the potential side effects of KYZATREX?

Common side effects include increased blood pressure, and there are also risks of prostate cancer, blood clots, abuse, and liver problems. It is important to follow the prescribed dosage and monitor for any adverse effects[3].

Sources

1. Allied Market Research - Testosterone Replacement Therapy Market Size Report, 2032
2. 2023 Annual Report - [PDF] 2023 Annual Report
3. Biospace - Marius Pharmaceuticals Receives FDA Approval of KYZATREX
4. PR Newswire - Marius Pharmaceuticals Announces Final Published Phase 3 Data from MRS-TU-2019EXT Studying the Safety and Efficacy of FDA-Approved KYZATREX Testosterone Undecanoate CII Capsules