KYZATREX Drug Patent Profile

Which patents cover Kyzatrex, and when can generic versions of Kyzatrex launch?

Kyzatrex is a drug marketed by Marius and is included in one NDA. There are six 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. Five suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Kyzatrex

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:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	1
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

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 six US patents and one FDA Regulatory Exclusivity.

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

International Patents for KYZATREX

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

Country	Patent Number	Title	Estimated Expiration
Canada	2822435
World Intellectual Property Organization (WIPO)	2014143127
Spain	2710149

Market Dynamics and Financial Trajectory for KYZATREX (Testosterone Undecanoate)

Last updated: July 27, 2025

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Introduction

KYZATREX (testosterone undecanoate) presents a unique position within the testosterone replacement therapy (TRT) landscape. As an injectable androgen, KYZATREX offers specific pharmacokinetic advantages and treatment flexibility. Analyzing its market dynamics and financial trajectory entails understanding the evolving therapeutic landscape, regulatory considerations, competitive environment, and emerging opportunities shaping its commercialization prospects.

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Pharmaceutical Overview and Therapeutic Context

KYZATREX is a long-acting injectable testosterone undecanoate designed to treat male hypogonadism. Its mode of administration provides sustained testosterone levels, reducing the frequency of injections compared to shorter-acting formulations. The drug competes primarily with established TRT options such as testosterone gels, patches, and shorter-acting injections like testosterone enanthate and cypionate.

The global testosterone replacement therapy market is projected to expand significantly, driven by increasing awareness of male hypogonadism, aging populations, and advances in drug delivery systems [1]. KYZATREX's pharmacokinetic profile positions it favorably for patients seeking less frequent dosing and improved adherence.

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Market Dynamics

1. Growing Demand for TRT

The TRT market has experienced robust growth, forecasted to reach USD 4 billion by 2025, with a compound annual growth rate (CAGR) of approximately 7-9% [2]. Factors contributing include:

• Aging male populations globally.
• Improved diagnosis and screening protocols.
• Patient preference for convenient, effective treatment modalities.
• Increased acceptance of hormone therapy, despite concerns about safety.

KYZATREX’s long-acting profile aligns well with consumer demand for more convenient treatment options, which may accelerate its adoption over shorter-acting or topical formulations.

2. Regulatory Environment and Market Access

Regulatory approvals significantly influence KYZATREX’s commercial trajectory. In the United States, the FDA approved testosterone undecanoate (such as Aveed/Andriol) decades ago, with subsequent approvals expanding to other regions [3]. KYZATREX’s approval status, dosing guidelines, and label indications directly impact its market penetration.

Limited competitive barriers exist in certain regions, but regulatory hurdles for demonstrating safety—particularly regarding cardiovascular and prostate health—remain pivotal. A clear regulatory pathway enhances investor confidence and facilitates broader market access.

3. Competitive Landscape

KYZATREX faces competition from:

• Topical products: gels, patches, and creams (e.g., AndroGel, Testim).
• Other injectables: testosterone enanthate, cypionate, and recently introduced long-acting formulations.
• Pellet implants: offering semi-permanent solutions.

The market favors formulations offering ease of use, consistent testosterone levels, and fewer adverse effects. KYZATREX’s longer dosing intervals can provide a competitive edge, particularly for patients seeking less frequent injections and reduced application site reactions.

4. Prescriber and Patient Acceptance

Physician acceptance hinges on safety profile, efficacy, and ease of administration. Patient preferences are shifting toward therapies with minimal dosing frequency and predictable pharmacokinetics. KYZATREX’s once-every-10-14-week dosing schedule appeals to these needs, potentially increasing patient compliance and satisfaction.

5. Pricing and Reimbursement Factors

Pricing strategies and reimbursement policies heavily influence market penetration. Higher-priced injectable therapies may face reimbursement challenges, especially against inexpensive topical options. Demonstrating superior efficacy, safety, and patient quality of life improvements is essential to justify premium pricing.

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Financial Trajectory

1. Revenue Projections

Forecasting KYZATREX’s revenue involves assessing market share potential, prescribing patterns, and reimbursement dynamics. Given the expanding TRT market:

• Early adoption is anticipated among urologists and endocrinologists.
• Coverage and formulary inclusion in major health systems will catalyze revenue growth.
• Market penetration could reach 10-15% of the long-acting injectable market within 5 years post-launch, translating into billions annually in global sales (assuming a conservative market share of approximately 5-7%).

The trajectory is sensitive to clinical trial outcomes, safety profiles, and marketing efforts. First-mover advantage in the long-acting injectable segment may result in faster revenue accrual.

2. Cost Structure and Profitability

Development costs encompass manufacturing scale-up, clinical trials, regulatory submissions, and marketing. Once established, manufacturing efficiencies and economies of scale should improve gross margins. The profitability trajectory depends on:

• Pricing strategies aligned with perceived value.
• Market penetration rates.
• Competition-induced price erosion.

Operationally, achieving breakeven could occur within 3-5 years post-commercialization if market uptake aligns with projections.

3. Risks and Challenges

Key risks include:

• Regulatory delays or rejections.
• Safety concerns affecting prescriber confidence.
• Competition from biosimilars or new formulations.
• Market saturation and reimbursement limitations.

Addressing these challenges through robust clinical data, targeted marketing, and strategic partnerships will be central to financial success.

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Emerging Opportunities and Strategic Considerations

1. Expansion into New Geographies

Targeting emerging markets with rising disposable incomes and healthcare infrastructure investments offers growth avenues. Tailoring formulations to regional preferences and regulatory standards is essential.

2. Combination Therapies

Potential exists for combining KYZATREX with other modalities to enhance efficacy or address comorbidities such as osteoporosis or metabolic syndrome, creating new revenue streams.

3. Digital and Patient Engagement Strategies

Embracing digital health tools—telemedicine, adherence monitoring apps—can increase patient engagement, adherence, and ultimately, treatment outcomes, strengthening market position.

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Key Takeaways

• Market expansion potential: The global TRT market’s growth, driven by demographic shifts and technological innovations, signals favorable demand for KYZATREX’s long-acting injectable profile.
• Competitive advantage: Its extended dosing interval and pharmacokinetic stability differentiate KYZATREX from shorter-acting injectables and topical therapies, offering an attractive option for both prescribers and patients.
• Regulatory and reimbursement landscape: Navigating regulatory approvals and establishing payer confidence are critical to achieving substantial market penetration.
• Financial outlook: With strategic marketing, favorable safety profiles, and broad regulatory access, KYZATREX can achieve significant revenue growth, potentially reaching billions in sales within the next 5–7 years.
• Risks: Market hurdles, safety concerns, and competitive pressures warrant ongoing vigilance and robust clinical data to sustain long-term financial success.

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FAQs

1. What distinguishes KYZATREX from other testosterone therapies?
KYZATREX’s prolonged dosing interval (every 10-14 weeks) offers improved convenience and adherence over shorter-acting injectables and topical formulations, potentially enhancing patient compliance.

2. What are the main regulatory hurdles for KYZATREX?
Ensuring safety and efficacy through comprehensive clinical trials remains paramount. Regulations concerning cardiovascular and prostate safety influence approval pathways, with regional variations affecting market access.

3. How does pricing impact KYZATREX’s market adoption?
High pricing can limit reimbursement and patient access. Demonstrating superior efficacy, safety, and patient satisfaction are essential to justify premium pricing and facilitate insurance coverage.

4. What are the key competitors in the KYZATREX market?
Major competitors include topical gels (e.g., AndroGel), shorter-acting injectable testosterone (testosterone enanthate), and emerging long-acting formulations. Differentiation hinges on dosing convenience and pharmacokinetic profile.

5. What opportunities exist for KYZATREX beyond initial launch markets?
Expanding into emerging markets, exploring combination therapies, and integrating digital health solutions can diversify revenue streams and accelerate growth.

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References

1. MarketWatch. “Testosterone Replacement Therapy Market Size, Share & Trends Analysis.” 2022.
2. Fortune Business Insights. “Testosterone Replacement Therapy Market Global Market Trends & Forecasts.” 2021.
3. FDA. “Approval of testosterone undecanoate for hypogonadism.” 2014.