TESTOSTERONE Drug Patent Profile

When do Testosterone patents expire, and when can generic versions of Testosterone launch?

Testosterone is a drug marketed by Actavis Labs Ut Inc, Alembic, Amneal, Encube, Lupin, Padagis Israel, Perrigo Israel, Twi Pharms, Xiromed, Ani Pharms, Strides Pharma, Dr Reddys, Watson Labs, Apotex, Cipla, Lupin Ltd, Am Regent, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sandoz, Sun Pharm Inds Ltd, Watson Pharms Inc, Wilshire Pharms Inc, Nexus, Bel Mar, Elkins Sinn, and Lilly. and is included in fifty-nine NDAs.

The generic ingredient in TESTOSTERONE is testosterone propionate. There are sixty-nine drug master file entries for this compound. Additional details are available on the testosterone propionate profile page.

Summary for TESTOSTERONE

US Patents:	0
Applicants:	30
NDAs:	59
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	1,045
Patent Applications:	4,295
Drug Prices:	Drug price information for TESTOSTERONE
Drug Sales Revenues:	Drug sales revenues for TESTOSTERONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TESTOSTERONE
What excipients (inactive ingredients) are in TESTOSTERONE?	TESTOSTERONE excipients list
DailyMed Link:	TESTOSTERONE at DailyMed

See drug prices for TESTOSTERONE

See drug sales revenues for TESTOSTERONE

Recent Clinical Trials for TESTOSTERONE

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

Sponsor	Phase
Morten Hostrup, PhD	N/A
VA Office of Research and Development	Early Phase 1
Jonsson Comprehensive Cancer Center	Phase 2

See all TESTOSTERONE clinical trials

Pharmacology for TESTOSTERONE

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for TESTOSTERONE

Androgens

Anatomical Therapeutic Chemical (ATC) Classes for TESTOSTERONE

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AXIRON	Topical Solution	testosterone	30 mg/1.5 mL	022504	1	2013-01-29
FORTESTA	Gel	testosterone	10 mg/actuation	021463	1	2012-08-14
TESTIM	Gel	testosterone	1%	021454	1	2008-08-21

US Patents and Regulatory Information for TESTOSTERONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bel Mar	TESTOSTERONE PROPIONATE	testosterone propionate	INJECTABLE;INJECTION	080742-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Cipla	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	210362-002	Jun 19, 2018	AO	RX	No	No
Alembic	TESTOSTERONE	testosterone	SOLUTION, METERED;TRANSDERMAL	212882-001	Jun 14, 2021		DISCN	No	No
Sandoz	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	040615-001	Aug 10, 2006	AO	RX	No	No
Watson Labs	TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE	estradiol cypionate; testosterone cypionate	INJECTABLE;INJECTION	085603-001	Mar 13, 1986		DISCN	No	No

EU/EMA Drug Approvals for TESTOSTERONE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Warner Chilcott UK Ltd.	Intrinsa	testosterone	EMEA/H/C/000634 Intrinsa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.	Withdrawn	no	no	no	2006-07-28
Warner Chilcott  Deutschland GmbH	Livensa	testosterone	EMEA/H/C/000630 Livensa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.	Withdrawn	no	no	no	2006-07-28

TESTOSTERONE Market Analysis and Financial Projection Experimental

The Evolving Market Dynamics and Financial Trajectory of Testosterone Replacement Therapy

Introduction to Testosterone Replacement Therapy (TRT)

Testosterone replacement therapy (TRT) is a medical treatment designed to address hypogonadism, a condition characterized by the deficiency of testosterone in men. This hormone plays a crucial role in male sexual characteristics, spermatogenesis, and overall reproductive health. As the global population ages, the demand for TRT has been on the rise, driven by various factors including increasing health awareness, advancements in diagnostic and treatment options, and the growing need for supportive therapies.

Market Size and Growth Projections

The global testosterone replacement therapy market is experiencing significant growth. As of 2023, the market size was valued at approximately USD 1.98 billion and is projected to reach USD 2.93 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 4.0%[1][3][5].

Regional Growth

The market growth is not uniform across all regions. The Asia-Pacific region is expected to witness the fastest growth due to rapidly developing medical infrastructure, rising medical tourism, and increasing awareness about age-related testosterone deficiency. Countries like China and India are driving this growth with their expanding healthcare systems and growing awareness of men's health[5].

Key Drivers of Market Growth

Increasing Aging Population

One of the primary drivers of the TRT market is the aging population. As men age, their testosterone levels naturally decline, leading to symptoms such as fatigue, muscle mass reduction, depression, and sexual dysfunction. This demographic shift is fueling the demand for supportive therapies and diagnostic testing[1][3][5].

Growing Health Awareness

Public health campaigns and education by healthcare providers have significantly increased awareness about hypogonadism and its associated symptoms. This heightened awareness has led to higher diagnosis rates and a greater willingness among patients to seek treatment, thereby boosting market demand[3].

Advancements in Drug Delivery Technologies

Advancements in drug delivery technologies have enhanced the efficacy, safety, and patient compliance of TRT solutions. Products such as pellets, gels, patches, and injections have become more sophisticated, offering better treatment outcomes and contributing to market growth[1][3].

Market Segmentation

Product Type

The TRT market is segmented based on product type, with injectables, topicals, and other product types being the main categories. As of 2024, the injectables segment generated the highest revenue, valued at USD 1.1 billion[3].

Financial Implications and Market Dynamics

Impact on Financial Markets

Interestingly, testosterone levels have been studied for their potential impact on financial decision-making. Research indicates that higher levels of testosterone can make individuals more confident and willing to take risks, which can sometimes destabilize financial markets. For instance, studies have shown that traders with higher testosterone levels tend to invest more in risky assets, potentially leading to market bubbles and crashes[2][4].

Economic Factors

The economic factors influencing the TRT market include the rising healthcare expenditures in developing countries and the increasing spending on healthcare infrastructure. In regions like Asia-Pacific, the growth in medical tourism and the development of new healthcare facilities are driving the market forward[5].

Challenges and Restraints

High Regulatory Scrutiny and Safety Concerns

Despite the growth, the TRT market faces several challenges. High regulatory scrutiny and safety concerns are significant restraints. Regulatory bodies closely monitor the safety and efficacy of TRT products, which can slow down market growth[5].

High Risk of Side Effects

Another challenge is the high risk of side effects associated with TRT. Patients may experience a range of adverse effects, which can deter some from seeking treatment and impact market growth negatively[5].

Expert Insights and Statistics

Prevalence of Hypogonadism

According to the National Institutes of Health (NIH), approximately 4 to 5 million men in the U.S. alone suffer from hypogonadism, highlighting the vast market potential for TRT[3].

Impact on Daily Life

Testosterone therapy can significantly impact daily life, especially for men in high-stress professions. For example, a study featured a tech company co-founder who underwent testosterone therapy to manage the stresses of his job, illustrating the real-world application and necessity of TRT[2].

Technological Advancements

Diagnostic Capabilities

Advancements in diagnostic capabilities have improved the detection and diagnosis of hypogonadism. This has led to more accurate and timely treatment, further driving the demand for TRT products[3].

Treatment Options

The development of various treatment options, such as different formulations and delivery methods, has enhanced patient compliance and treatment outcomes. This diversity in treatment options is a key factor in the market's growth[1][3].

Regional Market Opportunities

Asia-Pacific Region

The Asia-Pacific region is poised for significant growth due to its rapidly developing medical infrastructure and increasing awareness about men's health. Countries like China and India are at the forefront of this growth, with their healthcare systems responding to the increased demand for TRT[5].

Conclusion

The testosterone replacement therapy market is on a trajectory of steady growth, driven by an aging population, increasing health awareness, and advancements in drug delivery technologies. While the market faces challenges such as regulatory scrutiny and safety concerns, the overall outlook is positive, with significant opportunities for growth, especially in the Asia-Pacific region.

Key Takeaways

• The global TRT market is projected to grow from USD 1.98 billion in 2023 to USD 2.93 billion by 2033 at a CAGR of 4.0%.
• The aging population and increasing health awareness are major drivers of market growth.
• Advancements in drug delivery technologies have enhanced the efficacy and safety of TRT products.
• The Asia-Pacific region is expected to witness the fastest growth due to developing medical infrastructure and increasing awareness.
• Regulatory scrutiny and safety concerns are significant restraints to market growth.

FAQs

Q: What is the primary driver of the testosterone replacement therapy market? A: The primary driver of the TRT market is the increasing aging population and the subsequent decline in testosterone levels, leading to a higher demand for supportive therapies and diagnostic testing.

Q: How does testosterone affect financial decision-making? A: Higher levels of testosterone can make individuals more confident and willing to take risks, which can sometimes destabilize financial markets by leading to overvaluation of assets and market bubbles.

Q: What are the main product types in the TRT market? A: The main product types in the TRT market include injectables, topicals, and other product types, with injectables generating the highest revenue.

Q: Which region is expected to witness the fastest growth in the TRT market? A: The Asia-Pacific region is expected to witness the fastest growth due to rapidly developing medical infrastructure, rising medical tourism, and increasing awareness about men's health.

Q: What are some of the challenges facing the TRT market? A: The TRT market faces challenges such as high regulatory scrutiny, safety concerns, and the high risk of side effects associated with treatment.

Sources

1. Global Testosterone Replacement Therapy Market Size To Worth USD 2.93 Billion By 2033, CAGR Of 4.0% - Globenewswire
2. How a hormone affects the way men think about money - WHYY
3. Testosterone Replacement Therapy Market Size Report, 2034 - Gminsights
4. Traders' hormones 'may destabilise financial markets' - Imperial News
5. Testosterone Replacement Therapy Market Size(2024-2031) - Skyquestt