Testosterone - Generic Drug Details

What are the generic 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-three 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 five patent family members in thirty-four countries.

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

Summary for testosterone

International Patents:	105
US Patents:	73
Tradenames:	23
Applicants:	45
NDAs:	76
Drug Master File Entries:	69
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	1,045
Patent Applications:	6,223
Drug Prices:	Drug price trends 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

Generic filers with tentative approvals for TESTOSTERONE

Applicant	Application No.	Strength	Dosage Form
		30MG/1.5ML ACTUATION	SOLUTION, METERED;TRANSDERMAL
		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

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
Sun Pharm Inds Ltd	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	201720-001	Jun 3, 2013		DISCN	No	No
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-001	Sep 28, 2018		RX	Yes	Yes	10,646,495		Y
Upsher Smith Labs	VOGELXO	testosterone	GEL;TRANSDERMAL	204399-002	Jun 4, 2014	AB2	RX	No	No	9,662,340		Y
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012	AB2	RX	Yes	No	8,729,057		Y
Cipla	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	210362-001	Jun 19, 2018	AO	RX	No	No

Expired US Patents for testosterone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	021015-002	Feb 28, 2000	9,125,816*PED
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997	4,863,970
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	8,063,029
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	8,178,518
Alza	TESTODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	019762-002	Oct 12, 1993	4,867,982

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

International Patents for testosterone

Country	Patent Number	Title	Estimated Expiration
Norway	20200014	Forbedret testosterongel og fremgangsmåte til anvendelse
Hong Kong	1223852
Brazil	PI0611134	método e composição para liberação transdérmica de fármaco
Croatia	P20130071
Spain	2399763

Market Dynamics and Financial Trajectory of Testosterone Replacement Therapy

The global testosterone replacement therapy (TRT) market is poised for steady growth, driven by demographic shifts, technological advancements, and evolving healthcare paradigms. Valued at approximately $2.03 billion in 2024, the market is projected to reach $2.73 billion by 2033, reflecting a compound annual growth rate (CAGR) of 3.2%[1][13]. This expansion is underpinned by the rising prevalence of hypogonadism, increased awareness of men’s health issues, and innovations in drug delivery systems. Below, we explore the multifaceted dynamics shaping this sector, from regional trends to competitive strategies, while contextualizing the financial and societal implications of testosterone’s role in modern medicine.

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Demographic and Epidemiological Drivers of TRT Demand

Aging Populations and Hypogonadism Prevalence

The correlation between aging and testosterone deficiency is a primary catalyst for market growth. As global demographics skew older—with nearly 20% of men over 60 experiencing low testosterone levels—the demand for TRT continues to escalate[3][15]. Hypogonadism, characterized by insufficient testosterone production, affects approximately 481,000 new patients annually in the U.S. alone, manifesting in symptoms such as fatigue, reduced libido, and muscle atrophy[3][6]. This epidemiological burden is compounded by lifestyle factors, including obesity and metabolic syndrome, which further suppress testosterone levels[3][14]. Consequently, healthcare systems are prioritizing TRT as a cornerstone of age-related care, with geriatric populations driving sustained prescription volumes.

Cultural Shifts in Men’s Health Awareness

A paradigm shift in societal attitudes toward male wellness has dismantled historical stigmas surrounding hormonal treatments. Public health campaigns and advocacy by organizations like the Endocrine Society have normalized discussions about testosterone deficiency, leading to higher diagnosis rates[1][13]. For instance, direct-to-consumer (DTC) telemedicine platforms now account for 15–20% of TRT prescriptions in North America, reflecting a preference for discreet, accessible care[4][6]. This cultural transformation is not confined to developed nations; emerging markets in Asia-Pacific and Latin America are witnessing similar trends as urbanization and digital connectivity expand health literacy[8][13].

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Innovations in Therapeutic Modalities and Delivery Systems

Diversification of Administration Routes

The TRT market has evolved beyond traditional injectables, with transdermal gels, patches, and oral formulations capturing significant market share. Injectable testosterone cypionate remains the dominant product type, generating over $636 million in revenue in 2024 due to its efficacy and established clinical protocols[3][14]. However, patient preference for non-invasive options is fueling growth in topical gels and implants, which offer convenience and steady hormone release[1][6]. Notably, the 2022 FDA approval of Kyzatrex (testosterone undecanoate), an oral therapy, marked a pivotal advancement, addressing compliance challenges associated with frequent injections[6][12].

Biotechnological Advancements and Personalized Medicine

Next-generation TRT formulations emphasize bioavailability and safety. Bioidentical hormones, structurally identical to endogenous testosterone, are gaining traction as alternatives to synthetic analogs, reducing adverse effects like erythrocytosis[4][14]. Concurrently, pharmacokinetic innovations, such as subcutaneous pellets and microneedle patches, are enhancing dose precision. These developments align with broader trends in personalized medicine, where genetic profiling tailors TRT regimens to individual metabolic profiles[8][13].

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Regional Market Dynamics and Growth Opportunities

North America: A Matured Yet Expanding Market

North America accounted for 42% of global TRT revenue in 2024, propelled by robust healthcare infrastructure and high hypogonadism awareness[3][6]. The U.S. alone contributed $736 million, driven by insurers’ expanding coverage of TRT and the presence of major players like AbbVie and Pfizer[14][15]. However, market saturation and generic competition pose challenges, with biosimilar entrants eroding brand-name drug margins by 10–15% annually[2][5].

Asia-Pacific: The Frontier of Growth

Asia-Pacific is anticipated to register the highest CAGR (5.1%) through 2030, driven by urbanization, rising disposable incomes, and healthcare modernization[6][8]. Countries like China and India are investing in endocrine care infrastructure, while Japan’s aging population presents a $450 million incremental opportunity[14][15]. Regulatory reforms, such as India’s 2024 fast-track approval for TRT generics, are further accelerating market penetration[6][8].

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Competitive Landscape and Strategic Imperatives

Consolidation and Portfolio Diversification

The TRT market is characterized by consolidation, with AbbVie, Pfizer, and Teva Pharmaceuticals collectively holding 55% of the global share[1][3]. Strategic acquisitions, such as Viatris’ 2023 purchase of a TRT-focused biotech firm, exemplify efforts to expand product pipelines[6][14]. Concurrently, companies are investing in DTC platforms to bypass traditional distribution channels, leveraging AI-driven analytics to target undiagnosed populations[2][8].

Regulatory and Patent Challenges

Despite growth prospects, the sector faces headwinds from patent expirations and regulatory scrutiny. The 2025 expiry of AbbVie’s AndroGel patent is expected to catalyze a 20% price decline, encouraging generic substitution[3][6]. Meanwhile, regulatory agencies are tightening safety monitoring amid concerns about cardiovascular risks, mandating post-marketing studies for new formulations[13][15].

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Financial Projections and Investment Considerations

Revenue Streams and Pricing Dynamics

The TRT market’s revenue is projected to grow at a 3.3–4.3% CAGR through 2030, with injectables and topicals remaining key revenue drivers[1][6][14]. However, pricing pressures from generics and tiered insurance reimbursements will constrain margin growth, particularly in North America and Europe[2][5]. Emerging markets, conversely, offer premium pricing opportunities due to limited competition and higher willingness-to-pay among affluent urban populations[8][13].

Investment in R&D and Emerging Markets

Pharmaceutical firms are allocating 12–15% of TRT-related revenue to R&D, focusing on long-acting formulations and combination therapies targeting comorbidities like osteoporosis[4][14]. Geographically, manufacturers are establishing partnerships in Southeast Asia and the Middle East, where regulatory barriers are lower and growth potential is untapped[6][8].

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Ethical and Societal Considerations

Balancing Therapeutic Benefits and Misuse Risks

While TRT alleviates hypogonadism symptoms, its off-label use for performance enhancement remains contentious. An estimated 18–25% of TRT prescriptions in the U.S. lack diagnostic verification, raising concerns about cardiovascular and hepatic complications[9][14]. Regulatory bodies are responding with stricter prescribing guidelines and public education campaigns to mitigate misuse[13][15].

Testosterone’s Broader Economic Implications

Emerging research on testosterone’s influence on risk-taking behavior introduces novel economic considerations. Studies suggest that traders with elevated testosterone levels exhibit increased confidence and volatility in financial decision-making[7][9][10]. While not directly impacting TRT market dynamics, these findings underscore hormone therapy’s societal ripple effects, warranting interdisciplinary dialogue among clinicians, economists, and policymakers.

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Conclusion: Navigating a Complex Future

The TRT market’s trajectory is shaped by a confluence of medical innovation, demographic imperatives, and regulatory landscapes. As the sector evolves, stakeholders must balance growth opportunities with ethical stewardship, ensuring therapies reach patients in need while curbing misuse. Future success will hinge on personalized delivery systems, emerging market expansion, and adaptive regulatory strategies. Ultimately, testosterone’s journey from molecule to market encapsulates the challenges and promises of modern pharmacotherapy—a testament to science’s capacity to enhance quality of life across the lifespan.

References

1. https://www.globenewswire.com/news-release/2025/02/10/3023711/28124/en/Testosterone-Replacement-Therapy-Market-Forecast-Report-2025-2033-with-Key-Player-Profiles-for-AbbVie-Clarus-Therapeutics-Ferring-Pharmaceuticals-Lupin-Pfizer-Teva-Pharmaceuticals-.html
2. https://www.prnewswire.com/news-releases/testosterone-replacement-therapy-market-to-grow-by-usd-461-million-2025-2029-driven-by-awareness-initiatives-on-hypogonadism-and-ai-driven-market-transformation---technavio-302344650.html
3. https://www.alliedmarketresearch.com/testosterone-replacement-therapy-market-A08394
4. https://www.marketresearch.com/Global-Industry-Analysts-v1039/Testosterone-Replacement-Therapy-TRT-39347153/
5. https://www.industryarc.com/Report/16288/testosterone-replacement-therapy-market.html
6. https://www.consegicbusinessintelligence.com/testosterone-replacement-therapy-market
7. https://whyy.org/segments/capstone-alan-the-role-of-testosterone/
8. https://www.researchandmarkets.com/report/testosterone-replacement-drug
9. https://pmc.ncbi.nlm.nih.gov/articles/PMC2827458/
10. https://pubsonline.informs.org/doi/pdf/10.1287/mnsc.2017.2836
11. https://www.verifiedmarketreports.com/product/testosterone-enanthate-market/
12. https://www.verifiedmarketreports.com/product/testosterone-api-market/
13. https://www.globenewswire.com/news-release/2025/02/10/3023711/0/en/Testosterone-Replacement-Therapy-Market-Forecast-Report-2025-2033-with-Key-Player-Profiles-for-AbbVie-Clarus-Therapeutics-Ferring-Pharmaceuticals-Lupin-Pfizer-Teva-Pharmaceuticals-.html
14. https://www.gminsights.com/industry-analysis/testosterone-replacement-therapy-market
15. https://www.thebusinessresearchcompany.com/report/testosterone-replacement-therapy-global-market-report

Last updated: 2025-04-14