TESTOSTERONE ENANTHATE - Generic Drug Details

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

Testosterone enanthate is the generic ingredient in three branded drugs marketed by Endo Pharms, Eugia Pharma, Hikma Farmaceutica, Nexus, Rising, Watson Labs, Watson Pharms Inc, and Antares Pharma Inc, and is included in nine NDAs. There are twenty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Testosterone enanthate has ninety-seven patent family members in fourteen countries.

There are eight drug master file entries for testosterone enanthate. Three suppliers are listed for this compound.

Summary for TESTOSTERONE ENANTHATE

International Patents:	97
US Patents:	23
Tradenames:	3
Applicants:	8
NDAs:	9
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	39
Patent Applications:	4,145
Drug Prices:	Drug price trends for TESTOSTERONE ENANTHATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TESTOSTERONE ENANTHATE
What excipients (inactive ingredients) are in TESTOSTERONE ENANTHATE?	TESTOSTERONE ENANTHATE excipients list
DailyMed Link:	TESTOSTERONE ENANTHATE at DailyMed

See drug prices for TESTOSTERONE ENANTHATE

Recent Clinical Trials for TESTOSTERONE ENANTHATE

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

Sponsor	Phase
The University of Texas Medical Branch, Galveston	Phase 2/Phase 3
North Florida/South Georgia Veterans Health System	Phase 2
North Florida Foundation for Research and Education	Phase 2

See all TESTOSTERONE ENANTHATE clinical trials

Pharmacology for TESTOSTERONE ENANTHATE

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for TESTOSTERONE ENANTHATE

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

US Patents and Regulatory Information for TESTOSTERONE ENANTHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-001	Sep 28, 2018		RX	Yes	Yes			Y
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018		RX	Yes	Yes			Y
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018		RX	Yes	Yes			Y

Expired US Patents for TESTOSTERONE ENANTHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-002	Sep 28, 2018

International Patents for TESTOSTERONE ENANTHATE

Country	Patent Number	Title	Estimated Expiration
Japan	2022058684
China	104487114	Needle assisted jet injection administration of testosterone compositions
European Patent Office	3177346	AMORTISSEUR DE CHOCS POUR SERINGUE, DESTINÉ À ÊTRE UTILISÉ DANS UN DISPOSITIF D'INJECTION (A SYRINGE SHOCK ABSORBER FOR USE IN AN INJECTION DEVICE)

TESTOSTERONE ENANTHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Testosterone Enanthate

Introduction to Testosterone Enanthate

Testosterone enanthate is a widely used formulation in the testosterone replacement therapy (TRT) market. It is an esterified form of testosterone, administered via intramuscular injection, and is known for its effectiveness in treating hypogonadism and other conditions associated with low testosterone levels.

Global Market Size and Growth

The global testosterone replacement therapy market, which includes testosterone enanthate, is projected to experience significant growth over the next few years. Here are some key statistics:

• The market size was valued at $1.9 billion in 2022 and is expected to reach $2.9 billion by 2032, growing at a CAGR of 4.2% from 2023 to 2032[4].
• Another report indicates that the market will grow to $2.26 billion by 2028 at a CAGR of 2.2%[1].

Market Drivers

Several factors are driving the growth of the testosterone replacement therapy market, including:

• Rise in Prevalence of Hypogonadism: Hypogonadism, characterized by insufficient testosterone production, affects a significant portion of the male population. Approximately 481,000 new cases of hypogonadism are estimated annually in men aged 40-69 years in the U.S.[4].
• Increasing Awareness of Men's Health: Growing awareness about men's health and overall wellbeing is contributing to the demand for TRT[4].
• Aging Population: The rise in the geriatric population is another key driver, as older men are more likely to experience low testosterone levels[4].
• Lifestyle Changes: Unhealthy lifestyles, including obesity, diabetes, and metabolic syndrome, are also contributing to the growth of the TRT market[4].

Product Type and Active Ingredient

• Injectable Segment: The injectable segment, which includes testosterone enanthate, dominated the market share in terms of revenue in 2022 due to its cost-effectiveness and greater bioavailability[4].
• Testosterone Cypionate and Testosterone Undecanoate: While testosterone cypionate currently dominates the market, testosterone undecanoate is expected to register the highest CAGR during the forecast period due to its availability in both injectable and oral dosage forms[4].

End User and Regional Analysis

• Clinics Segment: Specialty clinics, such as urology clinics, dominate the market in terms of revenue and are expected to register the fastest growth during the forecast period[4].
• North America and Asia-Pacific: North America accounted for the largest share of the market in 2022, but the Asia-Pacific region is anticipated to grow at the highest CAGR due to the rise in incidence of hypogonadism and unhealthy lifestyles[4].

Innovations in Delivery Systems

The market is witnessing advancements in treatment options, including innovative delivery systems such as transdermal patches, gels, and long-acting injections. These innovations enhance patient convenience and compliance, further driving market growth[4].

Pharmacokinetics of Testosterone Enanthate

• Administration and Efficacy: Testosterone enanthate is typically administered via intramuscular injection every 2 weeks, with a recommended dose of 100 to 200 mg. This regimen ensures quick masculinization effects and maintains safety[5].
• Bioavailability: The bioavailable form of testosterone, free testosterone (FT), is crucial for estimating the effectiveness of the treatment. FT levels reach their maximum within 3 days and decrease over time, necessitating regular injections[5].

Financial Trajectory

The financial trajectory of the testosterone replacement therapy market, including testosterone enanthate, is positive:

• Revenue Growth: The market is expected to grow from $1.9 billion in 2022 to $2.9 billion by 2032, indicating a significant increase in revenue[4].
• CAGR: The market is projected to grow at a CAGR of 4.2% from 2023 to 2032, which is higher than some other segments within the healthcare industry[4].

Competitive Analysis

The testosterone replacement therapy market is competitive, with key players such as AbbVie Inc, Besins Healthcare SA, Acerus Pharmaceuticals Corporation, and Amneal Pharmaceuticals Inc. These companies are driving innovation and growth through advanced treatment options and strategic market positioning[4].

Challenges and Opportunities

While the market is growing, there are challenges to be addressed:

• Regulatory Environment: Ensuring compliance with regulatory requirements is crucial for market growth.
• Consumer Awareness: Increasing awareness about the benefits and risks of TRT among consumers is essential.
• Innovative Delivery Systems: Developing more convenient and effective delivery systems can enhance patient compliance and market growth.

Key Takeaways

• The testosterone replacement therapy market, including testosterone enanthate, is expected to grow significantly due to rising prevalence of hypogonadism and increasing awareness of men's health.
• Innovations in delivery systems and growing demand in the Asia-Pacific region are key drivers.
• The market is projected to reach $2.9 billion by 2032, growing at a CAGR of 4.2%.
• Major players are driving growth through advanced treatment options and strategic market positioning.

FAQs

1. What is the projected market size of the testosterone replacement therapy market by 2032? The market is expected to reach $2.9 billion by 2032[4].

2. What is the primary driver of the growth in the testosterone replacement therapy market? The rise in prevalence of hypogonadism is a primary driver of the market growth[4].

3. 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 during the forecast period[4].

4. What are the common dosage and administration guidelines for testosterone enanthate? Testosterone enanthate is typically administered via intramuscular injection every 2 weeks, with a recommended dose of 100 to 200 mg[5].

5. Which companies are key players in the testosterone replacement therapy market? Key players include AbbVie Inc, Besins Healthcare SA, Acerus Pharmaceuticals Corporation, and Amneal Pharmaceuticals Inc[4].

Cited Sources

1. The Business Research Company. Testosterone Replacement Therapy Global Market Report 2024.
2. John Fawkes. Testosterone May Distort Markets And Hurt The Economy.
3. 360iResearch. Testosterone Replacement Therapy Market by Indication, Product ....
4. Allied Market Research. Testosterone Replacement Therapy Market Size Report, 2032.
5. Liebert Pub. Pharmacokinetics of Testosterone Enanthate After Intramuscular ....