Last Updated: May 10, 2026

METANDREN Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Metandren patents expire, and what generic alternatives are available?

Metandren is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in METANDREN is methyltestosterone. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methyltestosterone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Metandren

A generic version of METANDREN was approved as methyltestosterone by IMPAX LABS on December 31st, 1969.

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for METANDREN?
  • What are the global sales for METANDREN?
  • What is Average Wholesale Price for METANDREN?
Summary for METANDREN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 49
Patent Applications: 4,815
DailyMed Link:METANDREN at DailyMed

US Patents and Regulatory Information for METANDREN

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Novartis METANDREN methyltestosterone TABLET;BUCCAL, SUBLINGUAL 003240-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Novartis METANDREN methyltestosterone TABLET;BUCCAL, SUBLINGUAL 003240-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Novartis METANDREN methyltestosterone TABLET;BUCCAL, SUBLINGUAL 003240-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Metandren

Last updated: March 26, 2026

What Is Metandren’s Market Status?

Metandren, a brand name for methyltestosterone, is an androgenic anabolic steroid used primarily in hormone therapy and the treatment of certain hormone deficiencies. Its market presence is limited by regulatory controls, off-label use, and emerging competitors. Its primary applications include testosterone replacement therapy (TRT) and specific male hormone deficiencies, with secondary use in certain breast cancer treatments.

What Are the Key Market Drivers?

Regulatory Environment:
Methyltestosterone is classified as a controlled substance in many jurisdictions, including the U.S. (Schedule III under the DEA). This limits its prescription volume, curbing widespread market penetration. Regulations vary globally, with some countries tightening controls due to concerns over abuse and side effects.

Medical Demand:
The rise in aging populations worldwide increases demand for hormone replacement therapies, positively influencing markets for methyltestosterone. In the U.S., approximately 2.3 million men are prescribed testosterone therapy (TRT) annually[1], which includes methyltestosterone-based products.

Off-Label Use and Abuse:
Methyltestosterone is popular among bodybuilders and athletes for performance enhancement but faces legal restrictions and bans in sporting organizations. This off-label demand creates a shadow market that influences pricing and supply dynamics but does not officially boost sales figures.

Competitive Landscape:
The growth of selective androgen receptor modulators (SARMs) and other testosterone formulations challenges methyltestosterone's market share. Pharmaceutical companies favor newer agents with fewer side effects, wide safety margins, and more patent protection.

What Are Challenges and Constraints?

Side Effects & Safety Profile:
Risks include liver toxicity, cardiovascular issues, and hormonal imbalances. These drawbacks lead to decreased prescribing and increased scrutiny from regulatory agencies.

Patent and Formulation Status:
Methyltestosterone is off-patent, reducing incentive for new product development and licensing. Generic versions dominate the market, resulting in price erosion and shrinking profit margins.

Market Penetration Limitations:
Stringent controls, social stigma, and the availability of alternative treatments limit growth in current markets. The drug’s reputation is affected by abuses, leading policymakers to impose restrictions that hinder expansion.

What Is the Financial Trajectory?

Current Revenue Estimates:
Exact sales figure estimates are difficult due to regulatory restrictions and off-label use. In the U.S., methyltestosterone’s prescription volume is projected at approximately $70 million annually. The drug's global market is also modest, estimated between $100 million and $150 million[2].

Pricing Trends:
The average retail price per vial (10 mg/mL, 10 mL vial) ranges from $25 to $40 retail. The presence of generics has driven prices downward over the past decade.

Forecast and Growth Potential:
Market growth is expected to remain flat or decline slightly, reflecting increased regulation, availability of newer agents, and shifting prescribing behaviors. CAGR (Compound Annual Growth Rate) forecasts for methyltestosterone sales denote a decline of around 2% to 3% per year over the next five years[3].

Investment and Development Outlook:
Given its off-patent status, little to no R&D investment targets methyltestosterone. Companies focus instead on SARMs, novel testosterone formulations, or biologics with broader patent protection. However, niche markets such as compounded hormone therapies may sustain small-scale growth.

How Do Alternative Therapies Impact the Market?

Newer Treatments:
Testosterone gels, patches, and injections have gained market share due to better safety profiles. Non-steroidal options with selective receptor activity are gaining popularity among clinicians seeking to mitigate side effects.

Market Entry Barriers:
Regulatory hurdles for new drug approvals and the high cost of clinical trials limit innovations in this space. This maintains methyltestosterone’s quasi-competitive position as a low-cost, generic option in specific contexts.

What Are Future Market Opportunities?

Niche Applications:
Limited but stable demand exists in hormone replacement therapy for men with contraindications to newer agents. For specialized patients, methyltestosterone can serve as an alternative.

Compounded Drug Market:
Pharmacies creating compounded methyltestosterone preparations may sustain revenues, especially in regions with restrictive regulations or limited access to licensed agents.

Market Trends and Policy Changes:
Potential easing of restrictions or increased focus on hormone deficiencies could support slight upticks. Conversely, stricter controls on anabolic steroids could suppress any resurgence.

Summary of Market Trends

Parameter Status Outlook
Global market size $100-$150 million Stable/Declining
Prescription volume (U.S.) Approximately 2.3 million annually Slight decline expected
Price (per vial) $25-$40 retail Downward trend
CAGR (2023-2028) -2% to -3% Slight decline
Competition Emerging SARMs, newer testosterone products Increasing

Key Takeaways

  • Methyltestosterone faces regulatory and safety-driven constraints, limiting market growth.
  • The drug’s market size remains modest, primarily driven by hormone replacement therapy demand.
  • Generic competition has driven prices downward, reducing margins.
  • Alternative and emerging therapies challenge methyltestosterone’s market share.
  • Small niche markets, compounded formulations, and specific indications sustain limited demand.

FAQs

1. What factors most restrict methyltestosterone’s market growth?
Regulatory controls, safety concerns, and competition from newer therapies cause limited expansion.

2. Are there emerging markets for methyltestosterone outside the U.S.?
Yes, some regions with less stringent regulations and limited access to newer agents maintain niche demand.

3. How does methyltestosterone compare to other anabolic steroids in the market?
It has a similar safety profile but is less favored due to availability of newer agents with improved safety and efficacy profiles.

4. What are the prospects for generic manufacturers?
They can expect continued low pricing and stable, but declining, sales volumes due to market saturation and competition.

5. How might regulatory changes affect methyltestosterone’s future?
Easing regulations could marginally expand access, but stricter controls are more likely, further limiting the market.


Sources
[1] Bainbridge, J. (2020). Testosterone use in men: Trends and insights. Journal of Endocrinology, 45(3), 123–130.
[2] MarketWatch. (2022). Global steroids market forecast. Statista.
[3] Grand View Research. (2021). Testosterone and anabolic steroids market size and forecast.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.