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Last Updated: December 22, 2024

TESTOSTERONE - Generic Drug Details


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

Testosterone is the generic ingredient in twenty-three branded drugs marketed by Abbvie, Alza, Acerus, Besins Hlthcare, Endo Operations, Actavis Labs Ut Inc, Alembic, Amneal, Encube, Lupin, Padagis Israel, Perrigo Israel, Twi Pharms, Xiromed, Upsher Smith Labs, Ani Pharms, Strides Pharma, Dr Reddys, Watson Labs, Eli Lilly And Co, Apotex, Cipla, Lupin Ltd, Auxilium Pharms Llc, Pfizer, Am Regent, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sandoz, Sun Pharm Inds Ltd, Watson Pharms Inc, Wilshire Pharms Inc, Azurity, Endo Pharms, Nexus, Antares Pharma Inc, Bel Mar, Elkins Sinn, Lilly, Tolmar, Marius Pharms Llc, and Verity, and is included in seventy-six NDAs. There are seventy-six patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Testosterone has one hundred and twenty patent family members in thirty-nine countries.

There are sixty-nine drug master file entries for testosterone. Eighteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for TESTOSTERONE

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Drug Sales Revenue Trends for TESTOSTERONE

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Recent Clinical Trials for TESTOSTERONE

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

SponsorPhase
Morten Hostrup, PhDN/A
VA Office of Research and DevelopmentEarly Phase 1
Jonsson Comprehensive Cancer CenterPhase 2

See all TESTOSTERONE clinical trials

Generic filers with tentative approvals for TESTOSTERONE
Applicant Application No. Strength Dosage Form
⤷  Subscribe⤷  Subscribe30MG/1.5ML ACTUATIONSOLUTION, METERED;TRANSDERMAL
⤷  Subscribe⤷  Subscribe750MG/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
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for TESTOSTERONE
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
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-001 Mar 27, 2019 RX Yes No 10,543,219 ⤷  Subscribe ⤷  Subscribe
Rising TESTOSTERONE ENANTHATE testosterone enanthate INJECTABLE;INJECTION 040647-001 Oct 5, 2009 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-002 Sep 28, 2018 RX Yes Yes 9,180,259 ⤷  Subscribe Y ⤷  Subscribe
Besins Hlthcare ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 AB RX Yes Yes 8,741,881 ⤷  Subscribe ⤷  Subscribe
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-001 Sep 28, 2018 RX Yes Yes 11,446,441 ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TESTOSTERONE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Operations TESTIM testosterone GEL;TRANSDERMAL 021454-001 Oct 31, 2002 7,608,609 ⤷  Subscribe
Besins Hlthcare ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 9,132,089*PED ⤷  Subscribe
Acerus NATESTO testosterone GEL, METERED;NASAL 205488-001 May 28, 2014 8,784,869 ⤷  Subscribe
Besins Hlthcare ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 9,125,816*PED ⤷  Subscribe
Abbvie ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-002 May 2, 1997 4,983,395 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for TESTOSTERONE

Country Patent Number Title Estimated Expiration
Russian Federation 2006120468 СИСТЕМА ДОСТАВКИ С КОНТРОЛИРУЕМЫМ ВЫСВОБОЖДЕНИЕМ ДЛЯ НАЗАЛЬНОГО ПРИМЕНЕНИЯ ⤷  Subscribe
Taiwan I350176 ⤷  Subscribe
Turkey 201815853 ⤷  Subscribe
Norway 344564 ⤷  Subscribe
European Patent Office 2450041 Gel améliore à base de testostérone pour utilisation dans le traitment de l'hypogonadisme (Improved testosterone gel for use in the treatment of hypogonadism) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

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

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