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:	57
Clinical Trials:	2
Patent Applications:	6,889
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
Purepac Pharm	METHYLTESTOSTERONE	methyltestosterone	TABLET;BUCCAL, SUBLINGUAL	080308-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lilly	METHYLTESTOSTERONE	methyltestosterone	TABLET;BUCCAL, SUBLINGUAL	080256-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Bausch	TESTRED	methyltestosterone	CAPSULE;ORAL	083976-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

METHYLTESTOSTERONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Methyltestosterone

Overview of Methyltestosterone

Methyltestosterone is a synthetic anabolic steroid hormone used primarily for the treatment of testosterone deficiency in men and certain conditions in women, such as advanced breast cancer and symptoms of menopause[3].

Market Size and Growth

The methyltestosterone market is anticipated to experience significant growth over the forecast period from 2024 to 2032. This growth is driven by several key factors, including an increasing demand for hormone replacement therapies and the expanding prevalence of conditions such as hypogonadism and breast cancer.

• The market is projected to grow at a notable compound annual growth rate (CAGR) during this period, reflecting the rising need for effective treatments for hormone-related disorders[4].

Market Segmentation

The methyltestosterone market can be segmented based on several criteria:

By Type

• The market is segmented into Type I and Type II methyltestosterone, each with different applications and market shares. Type I is often used for testosterone replacement therapy, while Type II may be used for other specific conditions[1].

By Application

• The primary applications include testosterone deficiency in men, breast cancer in women, and other hormone-related conditions. The CAGR for each application segment varies, with testosterone replacement therapy expected to dominate the market[5].

By Region

• Geographically, the market is segmented into various regions, with North America and Europe expected to be significant contributors due to advanced healthcare infrastructure and higher awareness of hormone replacement therapies. However, emerging markets in Asia-Pacific are also expected to show substantial growth[5].

Market Drivers

Several factors are driving the growth of the methyltestosterone market:

Increasing Prevalence of Hormone-Related Disorders

• The rising incidence of hypogonadism and breast cancer is a major driver. As the global population ages, the demand for hormone replacement therapies is expected to increase[5].

Advancements in Healthcare Infrastructure

• Improvements in healthcare infrastructure, especially in developing countries, are making these treatments more accessible. This increased accessibility is driving market growth[5].

Growing Awareness and Acceptance

• Greater awareness and acceptance of hormone replacement therapies among both healthcare providers and patients are contributing to the market's expansion[4].

Market Restraints

Despite the growth drivers, there are several restraints that could impact the market:

Regulatory Challenges

• Strict regulatory requirements and the need for continuous monitoring of side effects can hinder the market growth. Methyltestosterone is a schedule III drug in the US, which imposes certain restrictions on its use and distribution[3].

Side Effects and Adverse Reactions

• The drug is associated with several side effects, including liver damage, cardiovascular issues, and psychological changes. These adverse effects can limit its adoption and affect market growth[3].

Competition from Alternative Therapies

• The presence of alternative treatments and therapies can also act as a restraint. Patients may opt for other treatments that have fewer side effects or are more effective in the long term[5].

Financial Trajectory

The financial trajectory of the methyltestosterone market is expected to be positive, driven by the factors mentioned above.

Revenue Forecast

• The market revenue is projected to increase significantly from 2024 to 2032, with a steady CAGR. This growth will be fueled by increasing demand and expanding market reach[4].

Regional Revenue Contribution

• North America and Europe are expected to contribute substantially to the revenue, while the Asia-Pacific region is anticipated to show rapid growth due to its large population and improving healthcare infrastructure[5].

Competitive Analysis

The methyltestosterone market is characterized by a competitive landscape with several key players:

Market Share

• The market share is distributed among various pharmaceutical companies, with some players holding a significant share due to their established brand presence and extensive distribution networks[1].

Product Differentiation

• Companies are focusing on product differentiation through innovative formulations and delivery methods to capture a larger market share. For example, oral formulations with enhanced bioavailability are gaining traction[3].

Technological Trends

Technological advancements are playing a crucial role in the methyltestosterone market:

Improved Formulations

• The development of new formulations, such as oral tablets and capsules with enhanced bioavailability due to the methyl group, is improving patient compliance and treatment efficacy[3].

Digital Health Integration

• The integration of digital health technologies, such as telemedicine and patient monitoring systems, is making it easier for patients to access and manage their hormone replacement therapies[5].

Consumer Behavior Analysis

Consumer behavior is a critical factor influencing the market dynamics:

Patient Awareness and Education

• Increased awareness and education among patients about the benefits and risks of hormone replacement therapies are driving demand. Patients are more likely to seek medical advice and adhere to treatment plans when well-informed[1].

Preference for Convenient Treatments

• Patients are increasingly preferring treatments that are convenient and have minimal side effects. This preference is driving the demand for oral formulations and other user-friendly delivery methods[3].

Key Takeaways

• The methyltestosterone market is expected to grow significantly from 2024 to 2032, driven by increasing demand for hormone replacement therapies.
• The market is segmented by type, application, and region, with North America and Europe being key contributors.
• Regulatory challenges, side effects, and competition from alternative therapies are potential restraints.
• Technological advancements and improved formulations are enhancing treatment efficacy and patient compliance.
• Consumer awareness and preference for convenient treatments are driving market growth.

FAQs

Q: What are the primary uses of methyltestosterone?

• Methyltestosterone is primarily used to treat testosterone deficiency in men and advanced breast cancer in women. It is also used to treat other hormone-related conditions such as delayed puberty and menopause symptoms[3].

Q: What is the expected CAGR of the methyltestosterone market from 2024 to 2032?

• The market is projected to grow at a notable CAGR during this period, though the exact rate can vary depending on the source and specific market conditions[4].

Q: Which regions are expected to dominate the methyltestosterone market?

• North America and Europe are expected to be significant contributors, while the Asia-Pacific region is anticipated to show rapid growth due to its large population and improving healthcare infrastructure[5].

Q: What are the major restraints affecting the methyltestosterone market?

• Regulatory challenges, side effects, and competition from alternative therapies are the major restraints affecting the market growth[3][5].

Q: How are technological advancements impacting the methyltestosterone market?

• Technological advancements, such as improved formulations and digital health integration, are enhancing treatment efficacy and patient compliance, thereby driving market growth[3][5].

Sources

1. Cognitivemarketresearch.com: Global Methyltestosterone Market Report 2024 Edition.
2. Dataintelo.com: Methyltestosterone Market Report | Global Forecast From 2023 To 2030.
3. DrugBank: Methyltestosterone: Uses, Interactions, Mechanism of Action.
4. Northeast.newschannelnebraska.com: Methyltestosterone Market Report 2024 Emerging Trends, Size and Share 2032.
5. Marketmonitorglobal.com: Methyltestosterone Market, Global Outlook and Forecast 2024-2030.