METHYLTESTOSTERONE - Generic Drug Details

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

Methyltestosterone is the generic ingredient in nine branded drugs marketed by Heather, Impax Labs Inc, Novitium Pharma, Bausch, Chartwell, Valeant Pharm Intl, Schering, Novartis, Impax Labs, Lilly, Purepac Pharm, Pvt Form, Tablicaps, Usl Pharma, Valeant Pharms North, Inwood Labs, Kv Pharm, Lannett, Parke Davis, Watson Labs, and West Ward, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for methyltestosterone. Two suppliers are listed for this compound.

Summary for METHYLTESTOSTERONE

US Patents:	0
Tradenames:	9
Applicants:	21
NDAs:	36
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	6,947
What excipients (inactive ingredients) are in METHYLTESTOSTERONE?	METHYLTESTOSTERONE excipients list
DailyMed Link:	METHYLTESTOSTERONE at DailyMed

Recent Clinical Trials for METHYLTESTOSTERONE

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

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Solvay Pharmaceuticals	Phase 2

See all METHYLTESTOSTERONE clinical trials

Pharmacology for METHYLTESTOSTERONE

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for METHYLTESTOSTERONE

Anabolic Agents

Antineoplastic Agents, Hormonal

Anatomical Therapeutic Chemical (ATC) Classes for METHYLTESTOSTERONE

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

G03EK	Androgens and female sex hormones in combination with other drugs
G03E	ANDROGENS AND FEMALE SEX HORMONES IN COMBINATION
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for METHYLTESTOSTERONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	METANDREN	methyltestosterone	TABLET;BUCCAL, SUBLINGUAL	003240-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Novartis	METANDREN	methyltestosterone	TABLET;BUCCAL, SUBLINGUAL	003240-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Schering	ORETON	methyltestosterone	TABLET;BUCCAL	080281-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Valeant Pharm Intl	ANDROID 5	methyltestosterone	TABLET;BUCCAL	087222-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Tablicaps	METHYLTESTOSTERONE	methyltestosterone	TABLET;ORAL	080313-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Novartis	METANDREN	methyltestosterone	TABLET;BUCCAL, SUBLINGUAL	003240-005	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Methyltestosterone

Last updated: July 27, 2025

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Introduction

Methyltestosterone, a synthetic androgen and anabolic steroid, has a well-established pharmaceutical profile primarily used in testosterone replacement therapy (TRT) and certain hormonal deficiencies. Its unique chemical properties, therapeutic applications, patent landscape, and evolving regulatory environment shape its market dynamics. This report delineates the current market landscape, forecasted financial trajectory, and strategic considerations impacting methyltestosterone’s positioning in the pharmaceutical industry.

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Pharmaceutical Profile and Current Therapeutic Indications

Methyltestosterone was first synthesized in the 1930s and is approved for indications such as hypogonadism, delayed puberty, and cachexia. Its oral bioavailability distinguishes it from other testosterone formulations, contributing to its historical clinical utility. Despite its efficacy, methyltestosterone’s usage has declined in some regions owing to safety concerns and the development of alternative therapies.

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Market Drivers

1. Growing Prevalence of Hypogonadism and Aging Populations
   The global aging demographic contributes to increased prevalence of testosterone deficiency syndromes. According to the WHO, men over 60 account for a substantial share of androgen therapy candidates, sustaining demand for formulations like methyltestosterone.

2. Evolution of Oral Androgens
   Despite advancements, oral methyltestosterone remains favored in certain emerging markets where injectable and transdermal options have limited penetration. Its cost-effectiveness and ease of administration support continued demand.

3. Research and Off-Label Uses
   Investigations into anabolic applications, sports medicine, and treatment of chronic wasting conditions preserve niche markets, although regulatory scrutiny limits unchecked usage.

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Market Challenges

1. Regulatory Concerns and Safety Profile
   The anabolic and androgenic effects pose significant risks, including hepatotoxicity, cardiovascular events, and hormonal imbalances. Regulatory agencies such as the FDA restrict off-label use and impose strict safety guidelines, affecting market expansion.

2. Competition from Novel Therapies
   Emerging options like transdermal gels, patches, and long-acting injectables challenge methyltestosterone’s market share. Additionally, bioidentical testosterone formulations with improved safety profiles have gained favor.

3. Legal and Patent Landscape
   Many formulations of methyltestosterone are off-patent, leading to generic proliferation and price erosion. Patent expirations diminish profit margins and limit R&D investment incentives.

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Market Size and Financial Trajectory

Historic Market Performance
The methyltestosterone market was valued approximately at USD 200 million globally in 2021, with North America and Europe constituting significant shares, driven by high healthcare spending and stable demand for hormone replacement therapy. The market showed moderate growth compounded annually (~3-4%) over the previous five years, primarily fueled by emerging markets.

Forecasted Trends (2023-2030)
Projections indicate a gradual decline in methyltestosterone’s global market share, with an anticipated CAGR of approximately 1-2% over the next decade. The decline stems from:

• Shift towards safer, more modern androgen therapies.
• Stringent regulatory limitations.
• Increasing generic competition reducing pricing and profitability.

However, some niche markets, especially in developing regions with limited access to newer formulations, may sustain low-level demand. Additionally, potential revival could occur if new formulations with improved safety profiles are developed or if regulatory changes favor older orally administered steroids.

Revenue Projections
Considering current market trends, the global revenue from methyltestosterone is projected to decrease from USD 200 million in 2021 to approximately USD 170-180 million by 2030. Regional variations are notable, with stagnation in mature markets offset by marginal growth in emerging economies.

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Strategic Insights for Stakeholders

• Pharmaceutical Companies:
  Investments in formulation improvements (e.g., encapsulation techniques reducing hepatotoxicity), or repositioning methyltestosterone within niche therapeutic areas, could prolong market viability. Developing generic versions can enhance market share in cost-sensitive regions.

• Regulatory Bodies:
  Strict safety surveillance should continue. Clear guidelines on off-label use can control misuse while allowing legitimate therapeutic applications.

• Investors:
  The declining trend suggests limited growth prospects. Investment should focus on companies with innovative androgenic therapies or those diversifying into alternative hormonal products.

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Impact of Regulatory Changes and Emerging Technologies

The future of methyltestosterone hinges on regulatory shifts and technological progress. For instance, if regulatory authorities relax restrictions or approve new, safer oral formulations, market dynamics could shift favorably. Conversely, stricter controls or adverse safety reports could further dampen demand.

Nanotechnology and personalized medicine may also influence future formulations, potentially offering targeted delivery systems that minimize side effects, thereby extending methyltestosterone’s market lifespan if adapted effectively.

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Conclusion

Methyltestosterone’s market is characterized by a mature, gradually declining landscape driven by safety concerns, regulatory challenges, and competition from advanced formulations. While it maintains historical significance and niche relevance, its long-term financial trajectory indicates diminishing revenue prospects. Stakeholders must strategize around innovation, regulatory compliance, and regional market opportunities to sustain profitability.

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Key Takeaways

• The global methyltestosterone market was valued at approximately USD 200 million in 2021, with modest growth expected to decline toward USD 170-180 million by 2030.
• Market drivers include demographic trends, cost advantages, and niche uses, whereas challenges involve safety risks, regulatory barriers, and competition.
• Generics dominate the landscape, leading to price erosion and squeezed profitability.
• Innovation in safer formulations and targeted delivery systems could extend methyltestosterone’s relevance.
• Diversification into next-generation androgen therapies offers better growth prospects compared to reliance solely on methyltestosterone.

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FAQs

1. What are the primary therapeutic applications of methyltestosterone?
Methyltestosterone is chiefly used for testosterone replacement therapy in hypogonadism, delayed puberty, and cachexia. Its oral administration makes it suitable where injectable or topical options are less feasible.

2. Why has the usage of methyltestosterone declined in recent years?
Declines are driven by safety concerns such as hepatotoxicity, cardiovascular risks, and availability of safer alternatives like transdermal gels and injectable testosterone formulations. Regulatory restrictions further limit off-label and non-approved uses.

3. How does the patent landscape influence methyltestosterone’s market?
Most methyltestosterone formulations are off-patent, leading to widespread generic manufacturing. This results in significant price erosion and decreased profit margins for original producers, reducing R&D incentives.

4. What regional markets are expected to sustain demand for methyltestosterone?
Emerging markets in Asia, Africa, and parts of Latin America may continue to demand methyltestosterone due to limited access to newer therapies and cost sensitivities.

5. What are the prospects for methyltestosterone in future pharmaceutical development?
The future hinges on regulatory policies, safety improvements, and technological advances. Innovations such as targeted delivery and safer formulations could preserve niche markets but overall market decline is likely without major breakthroughs.

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Sources

[1] World Health Organization. (2022). Aging and health.
[2] IMS Health. (2021). Global hormone therapy market analysis.
[3] FDA. (2020). Regulation of testosterone replacement products.
[4] MarketWatch. (2022). Testosterone and anabolic steroids industry report.
[5] PubMed. (2021). Safety profile of methyltestosterone and associated risks.