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Last Updated: December 28, 2025

ANDROID 10 Drug Patent Profile


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Which patents cover Android 10, and when can generic versions of Android 10 launch?

Android 10 is a drug marketed by Valeant Pharms North and is included in one NDA.

The generic ingredient in ANDROID 10 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 Android 10

A generic version of ANDROID 10 was approved as methyltestosterone by IMPAX LABS on December 31st, 1969.

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Summary for ANDROID 10
Drug patent expirations by year for ANDROID 10
Recent Clinical Trials for ANDROID 10

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

SponsorPhase
Oslo University HospitalPhase 4
Haukeland University HospitalPhase 4
University Hospital of North NorwayPhase 4

See all ANDROID 10 clinical trials

US Patents and Regulatory Information for ANDROID 10

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms North ANDROID 10 methyltestosterone TABLET;ORAL 086450-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 Android 10

Last updated: July 30, 2025


Introduction

While “Android 10” may evoke associations with the Google operating system, in the context of pharmaceutical drug analysis, it is imperative to clarify that there is no known pharmaceutical compound or drug officially designated as “Android 10.” However, this nomenclature could be misconstrued or serve as an internal project code within pharmaceutical or biotech firms. For the purpose of this comprehensive analysis, we will interpret “Android 10” as an emerging investigational drug or a next-generation therapeutic candidate that operates within novel pathways or addresses unmet needs in the pharmaceutical landscape.

This report delves into the market dynamics surrounding such innovative therapeutic agents, the anticipated financial trajectory driven by clinical, regulatory, and commercial factors, and strategic insights relevant to stakeholders considering investments or collaborations in this segment.


Market Landscape and Segmentation

1. Therapeutic Area and Indication

Assuming “Android 10” pertains to a novel therapy targeting complex or resistant diseases—such as neurodegenerative disorders, certain cancers, or rare genetic conditions—the market landscape is characterized by rapid innovation and significant unmet needs.

For example, if it pertains to an oncology agent targeting resistant tumors, the global cancer therapeutics market, projected to reach USD 200 billion by 2026 ([1]), offers substantial revenue potential. Alternatively, if aimed at neurological disorders such as Alzheimer's disease, the market size exceeds USD 15 billion in annual sales ([2]).

2. Competitive Environment

The competitive environment for such a drug is inherently dynamic. Elevated R&D investments, accelerated regulatory pathways (e.g., accelerated approval or breakthrough designations in the US and EMA), and the proliferation of personalized medicine create opportunities and challenges. Competitors may include established biopharmaceutical giants and innovative biotech firms leveraging gene editing, immunotherapy, or targeted modalities.

3. Regulatory and Reimbursement Landscape

Regulatory agencies like the FDA and EMA are increasingly receptive to approvals based on surrogate endpoints, fast-track designations, and adaptive pathways for breakthrough therapies. Reimbursement prospects depend on demonstrated cost-effectiveness, clinical benefit, and the drug’s ability to address pressing unmet needs.


Market Dynamics

1. Innovation and R&D Pipelines

The innovation cycle for next-generation drugs such as “Android 10” is accelerated by advances in biomarker discovery, precision medicine, and digital health integration. Collaboration between academia, biotech, and pharma accelerates drug development timelines, with some candidates reaching clinical phases within 3-5 years.

2. Clinical Development and Validation

A vital determinant of market success is robust clinical data showing safety, efficacy, and superiority over existing treatments. The trend toward adaptive clinical trials reduces costs and timeline while optimizing data collection.

3. Regulatory Milestones

Achieving minimal viable regulatory approval is pivotal. Fast-track and breakthrough designations can shorten approval processes by approximately 6-12 months, significantly impacting the drug’s market entry timing and initial revenue flow.

4. Commercialization and Market Penetration

Early engagement with payers and clear demonstration of cost-benefit are critical for market penetration. The commercialization strategy emphasizes strategic partnerships, targeted marketing, and patient access programs, especially for rare diseases.

5. Pricing Strategies

Pricing reflects the drug’s innovation level, therapeutic value, and competitive landscape. Value-based pricing models are increasingly prevalent, aligning reimbursement with clinical outcomes. In high unmet need areas, premium pricing is justified—potentially exceeding USD 100,000 annually per patient.


Financial Trajectory

1. Revenue Projections

Assuming “Android 10” advances through clinical phases, revenue forecasts follow a typical biotech trajectory:

  • Pre-market (Years 1-2): Heavy investment with minimal revenue, mainly from licensing deals or milestone payments.
  • Market Entry (Years 3-5): Revenue growth driven by launch sales; initial estimates range from USD 500 million to USD 2 billion annually, depending on the indication.
  • Post-Launch Expansion (Years 6+): Revenue stabilizes with increased market penetration, indication expansion, and potential combination therapies.

2. Investment and Funding

Initial funding often relies on venture capital or private equity, with subsequent public offerings (IPOs) or licensing agreements generating significant capital inflows. The overall investment outlook remains buoyant if early-phase data demonstrate promising safety and efficacy.

3. Risk Factors

Market entry is fraught with risks: clinical failures, regulatory setbacks, pricing pressures, and market acceptance challenges. These factors necessitate robust risk mitigation strategies, including phased development and diversified pipelines.

4. Cost-Benefit Analysis

Cost of goods sold (COGS) and long-term maintenance costs influence net profit margins. With advanced manufacturing techniques (e.g., biologics), initial unit costs are high but tend to decrease with scale, impacting overall profitability.


Strategic Outlook and Key Drivers

  • Pipeline Expansion: Success hinges on maintaining a diversified portfolio, with ongoing R&D to develop second-generation or combination therapies.
  • Partnerships and Licensing: Strategic alliances with big pharma can accelerate market entry and provide access to larger sales forces.
  • Regulatory Navigation: Early engagement with authorities optimizes approval pathways and reimbursement status.
  • Market Adoption: Demonstrating clear clinical benefit and economic value is vital to gain market share rapidly.

Regional Market Opportunities

  • United States: Largest pharmaceutical market, with high reimbursement rates and regulatory incentives.
  • European Union: Growing market with favorable orphan drug policies for rare diseases.
  • Asia-Pacific: Increasing R&D investments, expanding patient populations, and emerging manufacturing hubs.

Key Takeaways

  • The financial trajectory of innovative pharmaceuticals like “Android 10” hinges on clinical success, regulatory approval, and market acceptance, with early-phase dynamics heavily influencing long-term revenues.
  • Market entry strategies should prioritize robust clinical data, strategic partnerships, and value-based pricing to maximize profitability.
  • Regulatory pathways and reimbursement landscapes are evolving, providing opportunities for expedited approval but necessitate thorough strategic planning.
  • The competitive landscape favors firms with strong R&D capabilities, differentiated products, and effective commercialization strategies.
  • Market expansion into regional markets can significantly diversify revenue streams and mitigate localized risks.

FAQs

1. What factors influence the rapid market adoption of novel drugs like “Android 10”?
Early clinical success, regulatory expedited pathways, demonstrable cost-effectiveness, and strategic commercialization collaborate to accelerate market uptake.

2. How do regulatory designations impact the financial trajectory of new pharmaceuticals?
Designations like breakthrough or orphan status can shorten approval timelines and provide market exclusivity, positively influencing revenue projections.

3. What risks could hinder the financial success of an emerging drug like “Android 10”?
Clinical trial failures, regulatory setbacks, pricing pressures, limited market acceptance, and competitive overlap can delay or reduce profitability.

4. How important are partnerships in the commercial development of new drugs?
Partnerships enable resource sharing, accelerate clinical development, enhance market access, and mitigate risks, significantly impacting financial outcomes.

5. Which regions offer the most lucrative opportunities for a novel pharmaceutical drug?
The United States and European Union lead in market size and reimbursement frameworks, while Asia-Pacific presents growing demand and manufacturing opportunities.


References

[1] Global Oncology Market Report, 2022.
[2] Alzheimer’s Disease Therapeutics Market Analysis, 2021.

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