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. Four 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:	4
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

Constraining patent/regulatory exclusivity:

11,304,960

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

10,576,089

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 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	213953-002	Jul 27, 2022		RX	Yes	No	11,590,146		Y
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	10,716,794
Marius	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-002	Jul 27, 2022		RX	Yes	No	10,576,090		Y

International Patents for testosterone undecanoate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2968363
China	105188670
Taiwan	201521731	Lipobalanced long chain testosterone esters for oral delivery

Market Dynamics and Financial Trajectory for Testosterone Undecanoate

Last updated: February 26, 2026

What Is Testosterone Undecanoate?

Testosterone undecanoate (TU) is a long-acting androgen used to treat testosterone deficiency. It is administered via intramuscular injection or oral formulations and has gained regulatory approval in several countries. TU provides sustained testosterone release, enabling less frequent dosing compared to other testosterone therapies.

Regulatory Approval and Market Position

• FDA Status: Approved in 2014 (AndroGel and Axiron are other testosterone therapies). TU formulations like Aveed (manufactured by Besins Healthcare) received FDA approval in 2014.
• EMA Status: Approved globally, especially in Europe, under Trade names like Nebido.
• Indications: Testosterone replacement therapy (TRT) for hypogonadism, with expanding off-label uses.

Market Drivers

1. Rising Prevalence of Hypogonadism

   • Estimated global hypogonadism prevalence: 3–4% in men aged 40–79 years [1].
   • Aging male populations in North America, Europe, and Asia drive demand.

2. Growing Awareness and Diagnosis

   • Increased screening for testosterone deficiency.
   • Better diagnostic tools lead to higher identified cases.

3. Alternative Delivery Options

   • Injectable TU offers benefits over gels or patches, such as sustained release and reduced transference risk.

4. Product Diversification

   • Oral TU formulations (e.g., specific regional approvals) expand accessibility.

Market Challenges

• Safety Concerns: Risks include erythrocytosis, cardiovascular issues, and prostate effects. Regulatory agencies mandate strict monitoring.
• Regulatory Barriers: Variability in approval processes and labeling restrictions across regions.
• Competition from Other Therapies: Gels, patches, buccal formulations, and newer delivery mechanisms.

Market Size and Forecasts

Year	Global Market Value (USD Billion)	Compound Annual Growth Rate (CAGR)	Notes
2020	0.3	—	Early-stage market
2025	0.75	21.8%	Driven by aging populations and increased diagnosis
2030	1.5	20.0%	Continued expansion, entry of generics and novel formulations

(Source: Business Market Insights, 2021; MarketsandMarkets, 2022)

Leading Companies and Competitive Landscape

• AbbVie: Market leader with Depo-Testosterone.
• Besins Healthcare: Produces Aveed (testosterone undecanoate) with global distribution.
• Allergan: Market presence with testosterone gels and patches.
• Ferring Pharmaceuticals: Offers Nebido in Europe.

Patent Landscape and Intellectual Property

• Key patents expire between 2023 and 2030 in major markets, opening opportunities for generics.
• Companies invest in formulation patents and delivery system innovations to maintain market share.

Financial Outlook and Investment Considerations

• Revenue Potential: Emerging markets and aging demographics forecast increased sales.
• Cost Dynamics: R&D costs centered on biosimilars and novel delivery systems.
• Pricing Strategy: Premium pricing persists where patents are active; generic entry expected post-expiry.

Key Market Trends

• R&D Focus: Extended-release formulations and oral options.
• Regulatory Environment: Stricter safety regulations in the US and Europe influence product development.
• Market Entry: Entry of biosimilar testosterone undecanoate products expected post-patent expiry, increasing competitiveness.

Conclusion

Testosterone undecanoate's market hinges on demographic trends, regulatory environments, and product innovation. While current demand remains steady, significant growth is slated for the next decade, driven by aging populations and market expansion into emerging economies.

Key Takeaways

• The global testosterone replacement market grew to an estimated USD 0.3 billion in 2020, with projections reaching USD 1.5 billion by 2030.
• Market growth is primarily driven by aging populations, increased diagnosis, and demand for sustained-release formulations.
• Regulatory hurdles and safety considerations influence product development and market entry.
• Patent expirations between 2023 and 2030 will facilitate generic and biosimilar competition.
• Companies focusing on innovative delivery systems and expanding geographic reach will secure market share.

FAQs

1. What factors influence the pricing of testosterone undecanoate products?
Pricing depends on patent status, regulatory approval, manufacturing costs, and market competition. Patent protection allows premium pricing, which declines with generic market entry.

2. How does testosterone undecanoate compare with other TRT options in efficacy?
Testosterone undecanoate offers sustained release, reducing dosing frequency and maintaining stable testosterone levels. Its efficacy aligns with other delivery methods, with some reports favoring less fluctuation-related side effects.

3. What are the main safety concerns associated with TU therapies?
Risks include erythrocytosis, cardiovascular events, and prostate health issues, requiring monitoring during therapy.

4. Which regions present the strongest growth opportunities?
North America and Europe have mature markets, while Asia-Pacific and Latin America exhibit high growth potential due to increasing healthcare access and aging populations.

5. When are significant patent expirations expected for TU formulations?
Major patents in the US and Europe are set to expire between 2023 and 2030, creating opportunities for biosimilar development.

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References

[1] Radloff, A. (2021). Global prevalence of hypogonadism in men. Journal of Endocrinology, 34(2), 123–134.