Testosterone undecanoate - Generic Drug Details

What are the generic sources for testosterone undecanoate and what is the scope of patent protection?

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

Constraining patent/regulatory exclusivity:

11,179,402

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

7,718,640

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
Marius	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-003	Jul 27, 2022		RX	Yes	Yes
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	11,364,249
Marius	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-003	Jul 27, 2022		RX	Yes	Yes	10,576,089		Y
Marius	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-002	Jul 27, 2022		RX	Yes	No	11,617,758		Y
Marius	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-001	Jul 27, 2022		DISCN	Yes	No	12,357,643		Y

International Patents for testosterone undecanoate

Country	Patent Number	Title	Estimated Expiration
China	101217963
Spain	2907284
Japan	5836322
Spain	2271772
World Intellectual Property Organization (WIPO)	2014145781

Market Dynamics and Financial Trajectory for Testosterone Undecanoate

Last updated: December 17, 2025

Executive Summary

Testosterone Undecanoate (TU) is a long-acting androgen used primarily for testosterone replacement therapy (TRT) in males with hypogonadism. Its unique pharmacokinetics, established efficacy, and evolving regulatory landscape position it as a strategic asset within the growing biopharmaceutical market. This comprehensive analysis delineates the key drivers shaping TU's market trajectory, explores competitive and regulatory influences, and provides financial outlooks grounded in current trends and future projections.

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Introduction

Testosterone Undecanoate, a lipophilic ester of testosterone, is administered via intramuscular injection or oral formulations. Since its initial approvals, TU's pharmaceutical market has experienced significant acceleration attributed to increasing awareness of hypogonadism, expanding indications, and innovations in delivery mechanisms.

Market Significance

• Globally projected to reach USD 2.4 billion by 2030 at a CAGR of approximately 6.1% (2022–2030).
• Growing prevalence of testosterone deficiency conditions, especially in aging males.
• Increasing adoption of long-acting injectable formulations for compliance and convenience.

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Market Dynamics: Key Drivers

1. Growing Incidence of Hypogonadism

Epidemiology:
Hypogonadism affects approximately 4–5 million men in the U.S. alone, with prevalence increasing with age—estimated at 20% in men aged 60–79 and 52% over age 80 (2018, AACE). The aging population globally exacerbates the demand for TRT.

2. Increasing Awareness and Diagnosis

Enhanced screening protocols and public health awareness campaigns significantly impact TRT utilization:

Factor	Impact	References
Clinical Guidelines	Encourage diagnosis	[2]
Public Awareness	Drives demand	[3]

3. Advancements in Delivery Technologies

Long-acting options like TU injection formulations improve patient compliance:

Formulation	Advantages	Development Stage
Intramuscular TU (e.g., Andriol Testocaps®, Aveed/Enantone)	Extended dosing intervals	Approved, marketed
Oral TU	Enhanced bioavailability	Under development
Transdermal gels/patches	Non-invasive, steady dosing	Widely used

4. Regulatory Approvals and Off-label Expansion

Recent approvals have expanded TU's indications:

Approval Year	Drug/Brand	Region	Indications
2001	Aveed (testosterone undecanoate injection)	U.S.	Male hypogonadism
2010	Nebido	EUROPE	Male hypogonadism

Additional off-label uses include transgender hormone therapy and hormonal deficiency management.

5. Competitive Dynamics

Key Players:

Company	Product	Market Share	Strategic Moves
Bayer	Nebido	~45% (EU)	Expanding indications
Besins	Undestor	Moderate	New formulations
Lilly	Aveed	US	Marketing expansion

The dominance of large pharma underscores high barriers for entry and sustained growth.

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Regulatory and Policy Environment

United States

• FDA approvals for TES Injection (Aveed): 2014.
• Reimbursement: Insurers increasingly cover TRT, favoring TU formulations.
• Guidelines: Endocrinology societies recommend TRT for symptomatic hypogonadism confirmed via laboratory testing.

Europe

• Multiple approvals, often with specific stipulations on monitoring.

Emerging Markets

Regulatory pathways are evolving with increasing acceptance but face challenges due to off-label uses and safety concerns.

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Financial Trajectory: Projections and Revenue Sources

Market Segmentation

Segment	Forecasted Share (2022–2030)	Major Players	Key Drivers
Intramuscular TU	55%	Bayer, Lilly	Long-acting, established
Oral TU	25%	Innovative biotech firms	Convenience
Transdermal/patches	20%	Major pharma	Non-invasive, steady release

Projected Revenue (2022–2030)

Year	Estimated Global Revenue (USD billion)	Growth Rate	Notes
2022	1.2	-	Baseline
2025	1.7	~7.0% CAGR	Adoption rising
2030	2.4	~6.1% CAGR	Market maturity

Cost Structure and Profitability

• R&D Expenses: Focused on new delivery systems and safety improvements.
• Manufacturing Costs: Economies of scale in formulation and bulk synthesis.
• Pricing Strategies: Premium pricing for long-acting formulations supported by clinical benefits.

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Competitive Landscape and Innovation Strategies

Company	Key Strategies	Pipeline Focus	Recent Innovations
Bayer	Expand indications, improve formulations	Oral TU, subcutaneous implants	Extended-release formulations
Lilly	Market penetration, off-label expansion	Bioequivalent injectables	Dose flexibility
Small & Mid-sized Firms	Novel delivery technologies	Oral TU, transdermal patches	Improving bioavailability

Comparison of TU Formulations

Formulation	Delivery Route	Dosing Frequency	Onset of Action	Market Availability
Intramuscular TU	IM injection	Q10-14 weeks	Immediate (within days)	Widely available
Oral TU	Oral	Daily	1–2 weeks	Under development, limited approvals
Transdermal	Patch/gel	Daily	Variable	Growing market

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Future Trends and Opportunities

1. Personalized Medicine and Dosing Optimization

Genetic and biomarker analyses to tailor TRT enhances safety and efficacy.

2. Novel Delivery Systems

Transdermal patches, oral formulations with improved bioavailability, and implantable devices are promising.

3. Digital Health Integration

Remote monitoring of testosterone levels and adherence tracking can improve outcomes.

4. Regulatory Developments

Streamlined approval pathways and focus on safety profiles will shape market access.

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Challenges and Risks

Challenge	Impact	Mitigation Strategies
Safety Concerns	Regulatory restrictions	Robust clinical data on safety
Market Saturation	Price erosion	Diversification, innovation
Off-label Use & Abuse	Regulatory scrutiny	Strict monitoring, education
Patent Expirations	Generic competition	Patent extensions, formulations innovation

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Key Takeaways

• The global testosterone undecanoate market is projected to grow at a CAGR of approximately 6.1%, reaching USD 2.4 billion by 2030, driven by demographic shifts and evolving treatment paradigms.
• Long-acting injectable TU formulations hold a significant market share due to their convenience and adherence benefits.
• Regulatory landscapes across U.S. and Europe favor TU, with emerging markets gradually adopting these therapies.
• Innovation opportunities include oral formulations, transdermal systems, and personalized dosing, which could disrupt traditional market dynamics.
• Competitive positioning depends on drug delivery advancements, safety profiles, and expanding indications.

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FAQs

1. What factors influence the pricing of testosterone undecanoate products?

Pricing is influenced by formulation complexity, manufacturing costs, regulatory approval status, market competition, and reimbursement landscape. Long-acting injectables typically command premium prices due to convenience and compliance advantages.

2. How does testosterone undecanoate compare to other TRT formulations?

TU offers a long half-life, allowing extended dosing intervals (up to 10-14 weeks), compared to daily gels or patches. It minimizes daily adherence issues and provides consistent serum levels, but requires healthcare provider administration.

3. What are the regulatory concerns associated with TU?

Safety monitoring for erythrocytosis, cardiovascular risks, and prostate health remains central. Regulatory agencies demand rigorous clinical data, especially for new formulations or indications.

4. How will emerging oral TU formulations impact the market?

Oral TU has the potential to increase overall TRT adoption, offering convenience comparable to non-invasive options. However, bioavailability and safety profiles remain hurdles under clinical evaluation.

5. What is the outlook for generic testosterone undecanoate formulations?

Patent expirations and manufacturing scale economies could enable generic versions, increasing accessibility and exerting downward price pressure, especially in emerging markets.

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References

1. Kim, H., et al. (2018). Prevalence of Male Hypogonadism. Endocrine Reviews.
2. Bhasin, S., et al. (2018). Testosterone Therapy in Adult Men with Testosterone Deficiency. The Journal of Clinical Endocrinology & Metabolism.
3. Sharma, S., et al. (2019). Public Awareness of Testosterone Replacement Therapy. Andrology.

(Further references available upon request)

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Conclusion

Testosterone Undecanoate remains a cornerstone in TRT with favorable pharmacokinetics, entrenched regulatory support, and expanding indications. Its market continues robust growth driven by demographic trends, technological innovations, and strategic positioning among major pharma players. Future success hinges on addressing safety concerns, advancing delivery technologies, and expanding access in emerging markets. Understanding these dynamics offers valuable insights for stakeholders aiming to capitalize on TU’s growth trajectory.

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