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 Pharms Llc, Verity, and Endo Operations, and is included in four NDAs. There are twenty-nine 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-seven patent family members in thirty-nine countries.

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

Summary for testosterone undecanoate

International Patents:	137
US Patents:	29
Tradenames:	4
Applicants:	4
NDAs:	4
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	59
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

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

NEW PRODUCT

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
Oslo University Hospital	Phase 2/Phase 3
Norwegian School of Sport Sciences	Phase 2/Phase 3

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
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-002	Mar 27, 2019		RX	Yes	No
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-002	Mar 27, 2019		RX	Yes	No
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-001	Mar 27, 2019		RX	Yes	No
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-003	Mar 27, 2019		RX	Yes	Yes			Y
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-002	Mar 27, 2019		RX	Yes	No

International Patents for testosterone undecanoate

Country	Patent Number	Title	Estimated Expiration
Brazil	PI1007025	composições esteroidais
Russian Federation	2007142204
China	101884639	Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
European Patent Office	2979699	SYSTÈMES D'ADMINISTRATION PHARMACEUTIQUE POUR DES MÉDICAMENTS HYDROPHOBES ET LEURS COMPOSITIONS (PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME)
Portugal	1457208

Testosterone undecanoate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Testosterone Undecanoate

Introduction to Testosterone Undecanoate

Testosterone undecanoate, sold under brand names such as Nebido, is an androgen and anabolic steroid medication primarily used for testosterone replacement therapy in adult males with conditions associated with a deficiency or absence of endogenous testosterone[2].

Market Size and Growth Projections

The global testosterone replacement therapy market, which includes testosterone undecanoate, is projected to experience significant growth. As of 2022, the global testosterone replacement therapy market was valued at $1.9 billion and is expected to reach $2.9 billion by 2032, growing at a compound annual growth rate (CAGR) of around 4-5% during the forecast period[1].

Segment Analysis

By Product Type

The injectable segment, which includes testosterone undecanoate, dominated the market share in terms of revenue in 2022. However, the segment is expected to see the highest CAGR during the forecast period due to the increasing adoption of implants, which offer prolonged and controlled release of testosterone[1].

By Active Ingredient

Testosterone undecanoate is expected to register the highest CAGR during the forecast period. This is attributed to its availability in both injectable and oral dosage forms, enhancing patient convenience and compliance[1].

By End User

The clinics segment, particularly specialty clinics like urology clinics, dominated the market in 2022 and is expected to register the fastest growth. These clinics cater to a large male patient base and provide specialized care for testosterone replacement therapy[1].

By Region

North America currently holds the largest share of the testosterone replacement therapy market, driven by the strong presence of major key players, a rising geriatric population, and well-developed healthcare facilities. However, the Asia-Pacific region is anticipated to grow at the highest CAGR due to the increasing incidence of hypogonadism and unhealthy lifestyles leading to lower testosterone levels[1].

Drivers of Market Growth

Rise in Prevalence of Hypogonadism

The significant surge in the prevalence of hypogonadism is a primary driver for the growth of the testosterone replacement therapy market. Hypogonadism affects a substantial portion of the male population, leading to symptoms such as fatigue, decreased libido, and mood disturbances. For instance, approximately 481,000 new cases of hypogonadism are estimated annually in men aged 40-69 years in the U.S.[1].

Increasing Awareness and Geriatric Population

Rising awareness about men's health and overall wellbeing, along with an increase in the geriatric population, are key factors driving the demand for testosterone replacement therapy. Older men are more likely to experience low testosterone levels, making this demographic a significant contributor to market growth[1].

Advancements in Treatment Options

The market has witnessed advancements in treatment options, including innovative delivery systems such as transdermal patches, gels, and long-acting injections. Testosterone undecanoate, in particular, offers the advantage of being available in both oral and injectable forms, which enhances patient compliance and convenience[1][2].

Financial Trajectory

Revenue Growth

The global testosterone undecanoate market is expected to grow substantially over the forecast period. The market size for testosterone undecanoate is part of the broader testosterone replacement therapy market, which is projected to reach $2.9 billion by 2032. The specific revenue growth for testosterone undecanoate is expected to be driven by its increasing adoption and the advantages it offers over other testosterone esters[1][3].

Competitive Landscape

The market is competitive, with key players such as AbbVie Inc, Besins Healthcare SA, Acerus Pharmaceuticals Corporation, and Amneal Pharmaceuticals Inc. Other notable competitors include Bayer AG, Endo Pharmaceuticals, Merck Sharp & Dohme, and Taro Pharmaceutical. The competitive landscape is characterized by continuous innovation and the introduction of new delivery systems, which are expected to drive market growth[1][4].

Regional Analysis

North America

North America currently dominates the market due to the strong presence of major key players and well-developed healthcare infrastructure. However, the region's growth rate is expected to be lower compared to the Asia-Pacific region[1].

Asia-Pacific

The Asia-Pacific region is anticipated to register the highest CAGR during the forecast period. This growth is driven by the rising incidence of hypogonadism and unhealthy lifestyles leading to lower testosterone levels in this region[1].

Challenges and Opportunities

Side Effects and Safety Concerns

While testosterone undecanoate offers several benefits, it also comes with potential side effects such as acne, increased hair growth, voice changes, hypertension, and elevated liver enzymes. Addressing these safety concerns through further clinical trials and improving treatment protocols is crucial for sustained market growth[2].

Regulatory Approvals

Recent regulatory approvals, such as the FDA approval of Kyzatrex (oral testosterone undecanoate capsules) in the United States, have expanded the market opportunities for testosterone undecanoate. Such approvals are expected to continue driving the market forward[2].

Key Takeaways

• The global testosterone replacement therapy market, including testosterone undecanoate, is projected to reach $2.9 billion by 2032.
• Testosterone undecanoate is expected to register the highest CAGR due to its availability in both injectable and oral forms.
• The Asia-Pacific region is anticipated to grow at the highest CAGR driven by the rise in incidence of hypogonadism.
• Advancements in treatment options and increasing awareness about men's health are key drivers of market growth.
• The market is competitive, with major players continuously innovating and introducing new delivery systems.

Frequently Asked Questions (FAQs)

1. What is the projected market size for the global testosterone replacement therapy market by 2032?

The global testosterone replacement therapy market is projected to reach $2.9 billion by 2032[1].

2. Which segment is expected to register the highest CAGR in the testosterone replacement therapy market?

The testosterone undecanoate segment is expected to register the highest CAGR during the forecast period due to its availability in both injectable and oral dosage forms[1].

3. What are the primary drivers of the testosterone replacement therapy market?

The primary drivers include the rise in prevalence of hypogonadism, increasing awareness about men's health, and the rise in the geriatric population[1].

4. Which region is expected to grow at the highest CAGR in the testosterone replacement therapy market?

The Asia-Pacific region is anticipated to grow at the highest CAGR due to the rising incidence of hypogonadism and unhealthy lifestyles[1].

5. What are some of the notable side effects of testosterone undecanoate?

Side effects include symptoms of masculinization like acne, increased hair growth, voice changes, hypertension, and elevated liver enzymes[2].

Cited Sources:

1. Allied Market Research - Testosterone Replacement Therapy Market Size Report, 2032
2. Wikipedia - Testosterone undecanoate
3. Market Research Intellect - Global Testosterone undecanoate Market Size And Forecast
4. Cognitive Market Research - Global Testosterone undecanoate Market Report 2024 Edition