Testosterone undecanoate - Generic Drug Details

What are the generic drug sources for testosterone undecanoate and what is the scope of freedom to operate?

Testosterone undecanoate is the generic ingredient in four branded drugs marketed by Tolmar, Marius, Verity, and Endo Operations, and is included in four NDAs. There are thirty-two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Testosterone undecanoate has one hundred and thirty-eight patent family members in thirty-nine countries.

There are seven drug master file entries for testosterone undecanoate. Five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for testosterone undecanoate

International Patents:	138
US Patents:	32
Tradenames:	4
Applicants:	4
NDAs:	4
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	61
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for testosterone undecanoate
What excipients (inactive ingredients) are in testosterone undecanoate?	testosterone undecanoate excipients list
DailyMed Link:	testosterone undecanoate at DailyMed

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

Dosage:

CAPSULE;ORAL

Dosage:

INJECTABLE;INTRAMUSCULAR

^*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 testosterone undecanoate

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

Sponsor	Phase
Morten Hostrup, PhD	N/A
University of Washington	PHASE1
Washington State University	PHASE1

See all testosterone undecanoate clinical trials

Generic filers with tentative approvals for TESTOSTERONE UNDECANOATE

Applicant	Application No.	Strength	Dosage Form
		750MG/3ML (250MG/ML)	INJECTABLE;INTRAMUSCULAR

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for testosterone undecanoate

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for testosterone undecanoate

G03BA	3-oxoandrosten (4) derivatives
G03B	ANDROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for TESTOSTERONE UNDECANOATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AVEED	Injection	testosterone undecanoate	250 mg/mL	022219	1	2014-06-11

US Patents and Regulatory Information for testosterone undecanoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes			Y
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-002	Mar 27, 2019		RX	Yes	No
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes			Y
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-002	Mar 27, 2019		RX	Yes	No
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-003	Mar 27, 2019		RX	Yes	Yes

International Patents for testosterone undecanoate

Country	Patent Number	Title	Estimated Expiration
South Africa	200700046	Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
World Intellectual Property Organization (WIPO)	2011082384
Portugal	2519230
Japan	2013516433
World Intellectual Property Organization (WIPO)	2010081032
Taiwan	200511997	Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels

Market Dynamics and Financial Trajectory for Testosterone Undecanoate

Last updated: July 27, 2025

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Introduction

Testosterone undecanoate (TU) is a long-acting androgen used in hormone replacement therapy (HRT) for hypogonadism in men. Its unique pharmacokinetics and delivery methods have positioned it as a vital therapeutic option, with significant growth potential amid evolving market dynamics. Understanding the comprehensive landscape—including regulatory trends, competitive positioning, commercialization challenges, and investment opportunities—is essential for stakeholders navigating this segment.

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Market Overview and Industry Context

Testosterone undecanoate represents a specialized sub-category within the broader androgen therapy market. As of 2022, the global testosterone replacement therapy (TRT) market was valued around USD 2.1 billion, projected to grow at a compound annual growth rate (CAGR) of approximately 6-8% through 2030 [1]. TU accounts for a notable fraction due to its favorable pharmacokinetic profile—offering sustained serum testosterone levels with less frequent injections compared to other formulations such as testosterone enanthate or topical gels.

The increasing prevalence of hypogonadism, coupled with growing awareness of age-related testosterone decline, furthers demand. Additionally, the global rise in chronic conditions linked to low testosterone—such as osteoporosis, depression, and cardiovascular issues—accelerates market expansion.

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Key Market Drivers

1. Rising Aging Population and Hypogonadism Prevalence

The aging demographic significantly drives demand for testosterone therapies. Data indicates that approximately 10-15% of men over 60 experience symptomatic hypogonadism [2]. With global life expectancy surpassing 72 years, the proportion of the elderly population is increasing, augmenting the need for effective testosterone delivery systems such as TU.

2. Advantages of Long-Acting Formulations

Testosterone undecanoate's injectable form (e.g., Nebido®/Undecanoate) provides biannual or quarterly dosing intervals, improving patient compliance and quality of life. This addresses adherence challenges linked with daily topical or gel applications, especially in clinical settings.

3. Regulatory Approvals and Off-Label Usage Expansion

Regulatory landscape shapes market accessibility. TU products like Nebido® have received approval across multiple jurisdictions—including the U.S., Europe, and Asia—expanding geographical footprints. Off-label use for female hypogonadism and transgender health, although controversial, constitutes an ancillary revenue channel.

4. Evolving Treatment Guidelines and Prescribing Trends

Emerging clinical guidelines endorse injectable TU due to consistent serum level maintenance. Increased physician comfort and patient acceptance support ongoing prescriptions, further propelling sales.

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Market Challenges and Constraints

1. Regulatory and Patent Environment

Patent expirations, notably of brand-name TU products, threaten generics entry, increasing price competition. Regulatory barriers remain in emerging markets—delaying widespread adoption and market penetration.

2. Safety Considerations and Market Penalties

Testosterone therapy, including TU, faces ongoing scrutiny over cardiovascular and prostate risks. Regulatory agencies and healthcare providers exercise caution, emphasizing careful patient selection and monitoring, which may hinder market growth.

3. Competition from Alternative Therapies

Oral testosterone formulations, topical gels, patches, and newer delivery methods (e.g., nasal gels, transdermal patches) create alternative treatment pathways. The competitive landscape is increasingly fragmented, sparking pricing pressures.

4. Market Penetration in Developing Regions

Limited healthcare infrastructure, lack of awareness, and regulatory delays slow TU adoption in low- and middle-income countries (LMICs). Cost sensitivity and reimbursement barriers compound challenges in these markets.

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Financial Trajectory and Investment Outlook

1. Revenue Projections

Given current trends, the TU segment is projected to demonstrate double-digit growth globally by 2025-2030. Major pharmaceutical companies—including Bayer, Abbott, and Endo Pharmaceuticals—invest in R&D and marketing initiatives to capitalize on this trajectory.

2. Innovation and Pipeline Developments

Emerging formulations aim to enhance bioavailability, stability, and safety profiles. For example, microemulsion-based injectables and sustained-release implants are under investigation, which may command premium pricing and market share.

3. Strategic Mergers and Acquisitions

Market consolidation—like recent acquisitions of generics portfolios—will influence competitive dynamics. The entrance of biosimilars and follow-on products is also anticipated, potentially impacting pricing and margins.

4. Market Risks and Investment Caution

Investors should consider risks surrounding regulatory delays, litigation related to safety profiles, and patent litigation. A balanced approach involves monitoring clinical trial outcomes, regulatory decisions, and patent reforms, especially in key markets such as the U.S., EU, and China.

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Regional Market Dynamics

United States: As the largest market, the U.S. dominates sales with mature regulatory pathways and established clinical guidelines. Reimbursement policies and shifting physician preferences influence sales trajectories.

Europe: High approval rates and favorable prescribing habits support steady growth. However, regulatory scrutiny over safety concerns has led to more conservative use patterns.

Asia-Pacific: Rapid demographic shifts and increasing healthcare investments position APAC as a promising growth zone. Local manufacturing and generic formulations under competitive pricing are key drivers.

Emerging Markets: Markets such as Latin America, the Middle East, and Africa pose growth opportunities but require strategic partnerships and local regulatory compliance.

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Strategic Recommendations for Stakeholders

• Pharmaceutical Companies: Invest in R&D for novel TU formulations that improve patient compliance, safety, and efficacy. Focus on emerging markets with scalable regulatory strategies.
• Investors: Monitor patent expirations and pipeline announcements. Engage with companies expanding into biosimilar and generic TU segments.
• Healthcare Providers: Embrace evidence-based prescribing of TU, emphasizing follow-up safety monitoring to optimize patient outcomes.
• Regulators: Encourage transparent safety evaluations and streamline approval processes for innovative TU delivery systems.

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Key Takeaways

• The testosterone undecanoate market is set for sustained growth, driven by demographic shifts, technological advances, and expanded clinical acceptance.
• Long-acting injectable formulations afford logistical and adherence advantages, positioning TU favorably in HRT portfolios.
• Competitive pressures from alternative routes of administration necessitate continual innovation and targeted marketing.
• Regulatory environments, safety concerns, and patent landscapes present both opportunities and challenges, requiring strategic agility.
• Emerging markets and pipeline innovations will dictate future growth trajectories, with strategic investments aligning to these trends.

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Frequently Asked Questions

Q1: What are the primary therapeutic indications for testosterone undecanoate?
A1: TU is primarily indicated for testosterone replacement therapy in adult males with hypogonadism, aiming to restore normal testosterone levels and alleviate associated symptoms.

Q2: How does testosterone undecanoate’s pharmacokinetic profile compare to other testosterone formulations?
A2: TU offers a long half-life, allowing for injections approximately every 10-14 weeks, unlike shorter-acting formulations which require more frequent dosing, thus improving compliance and serum level stability.

Q3: What are the safety concerns linked to TU therapy?
A3: Safety concerns include cardiovascular risks, erythrocytosis, polycythemia, and potential prostate-related issues. Regulatory agencies recommend careful patient selection and ongoing monitoring.

Q4: Which regions exhibit the highest growth potential for TU?
A4: North America and Europe are mature markets; however, Asia-Pacific and Latin America present substantial growth opportunities due to demographic trends and increasing healthcare infrastructure.

Q5: How might patent expirations influence the TU market?
A5: Patent expirations enable generic manufacturers to enter the market, reducing prices and increasing accessibility, but also heightening competitive pressures on brand-name products.

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References

[1] Grand View Research, "Testosterone Replacement Therapy Market Size, Share & Trends," 2022.
[2] Johnson, J., et al., "Epidemiology and Diagnosis of Male Hypogonadism," Endocrine Reviews, 2021.