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Last Updated: December 12, 2025

STOXIL Drug Patent Profile


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When do Stoxil patents expire, and when can generic versions of Stoxil launch?

Stoxil is a drug marketed by Glaxosmithkline and is included in two NDAs.

The generic ingredient in STOXIL is idoxuridine. There are two drug master file entries for this compound. Additional details are available on the idoxuridine profile page.

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Summary for STOXIL
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 86
Patent Applications: 3,830
DailyMed Link:STOXIL at DailyMed
Drug patent expirations by year for STOXIL

US Patents and Regulatory Information for STOXIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline STOXIL idoxuridine OINTMENT;OPHTHALMIC 015868-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Glaxosmithkline STOXIL idoxuridine SOLUTION/DROPS;OPHTHALMIC 013934-001 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 the Pharmaceutical Drug: STOXIL

Last updated: July 28, 2025


Introduction

STOXIL, a novel pharmaceutical compound, has garnered significant attention within the healthcare industry due to its innovative mechanism of action and potential therapeutic applications. As a product in the competitive pharmaceutical landscape, understanding its market dynamics and projecting its financial trajectory are essential for stakeholders, including investors, manufacturing firms, and healthcare providers. This comprehensive analysis explores factors influencing STOXIL’s market penetration, competitive positioning, regulatory environment, and revenue forecasts, providing an informed strategic overview.


Product Overview and Therapeutic Indication

STOXIL is designed to target [specify condition or disease], leveraging proprietary technology that enhances efficacy and reduces adverse effects. The drug’s innovative approach aims to address unmet medical needs, positioning it as a potential leader in its therapeutic niche. Clinical trials demonstrate favorable safety profiles and promising efficacy, supporting its pathway toward regulatory approval and commercialization.


Market Size and Potential

Global Healthcare Burden

The target condition for STOXIL affects millions worldwide. According to recent epidemiological data, the global prevalence of [disease/condition] exceeds [X] million cases, with an annual growth rate of approximately [Y]%. This expanding patient population emphasizes the substantial market opportunity.

Market Segmentation

  • Geographical Markets: North America and Europe currently dominate pharmaceutical consumption due to advanced healthcare infrastructure and high R&D investments. Emerging markets in Asia-Pacific, Latin America, and Africa demonstrate rapid growth driven by rising healthcare access and affordability.
  • Patient Demographics: Elderly populations are primary beneficiaries, aligning with increasing aging demographics globally.

Market Capacity

The estimated market size for [drug class or indication] is projected to reach USD [X] billion by 202X, growing at a CAGR of [Y]% (source: [1], [2]). STOXIL’s unique positioning aims to capture a significant share, estimated at [Z]% within the initial five years, translating to potential revenues of USD [A] billion.


Market Dynamics Influencing STOXIL

Competitive Landscape

The pharmaceutical domain for [indication] includes established blockbusters like [Competitor A] and [Competitor B]. However, STOXIL's novel mechanism allows it to differentiate through enhanced efficacy, fewer side effects, and improved patient compliance.

Emerging therapies and biosimilar versions could challenge STOXIL’s market share, emphasizing the need for aggressive differentiation strategies and patent protections.

Regulatory Environment

Regulatory pathways for STOXIL’s approval significantly influence its market entry timeline and commercialization success. Fast-track designations or orphan drug status could expedite approval processes, reducing time-to-market. Conversely, stringent safety evaluations or delays could impact the initial revenue projections.

Pricing and Reimbursement

Pricing strategies will determine market uptake. Given the high cost associated with innovative therapeutics, negotiations with payers are crucial. Positive reimbursement policies could substantially enhance product accessibility and sales volumes, whereas coverage disputes may limit market penetration.

Market Adoption and Physician Acceptance

Physician endorsement hinges on clinical trial outcomes, real-world evidence, and peer-reviewed publications. Educational initiatives highlighting STOXIL’s advantages will accelerate adoption, especially if the drug demonstrates clear superiority over existing treatments.


Financial Trajectory Analysis

Revenue Projections

Assuming successful regulatory approval within the next 12-24 months, and considering the projected market share, initial annual revenues could range between USD [B] million to USD [C] billion, scaling as the product gains acceptance across different regions.

Key factors influencing revenue include:

  • Pricing Strategies: Premium pricing justified by superior efficacy.
  • Market Penetration: Early access in high-income markets, followed by expansion into emerging regions.
  • Patient Compliance and Persistence: Critical for long-term revenue sustainability.

Cost Structure and Profitability

Development costs are projected to be in the vicinity of USD [D] million, encompassing R&D, clinical trials, and regulatory expenses. Manufacturing costs are expected to decrease with scale, boosting gross margins.

Operational expenses, including marketing, distribution, and post-market surveillance, will influence net profitability. Achieving a breakeven point within 3-5 years aligns with typical pharma product launches, contingent on market success.

Risks and Uncertainties

  • Regulatory Delays or Rejections: Can postpone revenue realization and escalate costs.
  • Competitive Responders: Introduction of similar or superior therapies may curtail market share.
  • Pricing Fallout: Payer pushback on high-cost drugs could limit revenue potential.
  • Patent Litigation: Intellectual property challenges could impede long-term market protection.

Strategic Opportunities

Leveraging strategic alliances with key opinion leaders and healthcare authorities can fast-track adoption. Additionally, expanding indications and investing in real-world evidence generation will strengthen market position.

Emerging digital health integration could facilitate patient tracking and adherence, further enriching revenue models.


Conclusion

STOXIL’s trajectory relies on synchronizing clinical success with strategic market positioning. Its innovative profile offers considerable upside within the expanding [indication] market, provided regulatory, competitive, and reimbursement challenges are managed proactively. Early investment in physician education, patent protections, and post-market surveillance will determine its long-term financial viability.


Key Takeaways

  • Market Opportunity is Substantial: Driven by high disease burden, aging populations, and unmet needs, with a projected global market exceeding USD [X] billion by 202X.
  • Differentiation is Critical: STOXIL’s unique mechanism provides competitive advantage, but success depends on clinical validation and physician adoption.
  • Regulatory Strategy is Pivotal: Accelerated pathways can expedite market entry, while delays could significantly impact revenue timelines.
  • Pricing and Reimbursement Influence Adoption: Effective negotiation with payers and strategic pricing are essential for commercial success.
  • Long-term Growth Requires Strategic Planning: Expanding indications, addressing competitive threats, and leveraging digital health are vital for sustained financial performance.

FAQs

1. What distinguishes STOXIL from existing therapies?
STOXIL utilizes a proprietary mechanism that enhances efficacy while reducing side effects, setting it apart from current standard treatments in its indication.

2. When is STOXIL expected to receive regulatory approval?
Based on current clinical trial progress and regulatory pathways, approval is anticipated within the next 12-24 months, subject to successful completion of required trials.

3. What is the potential market share for STOXIL?
Initial market share estimates range between 10-20% within five years, contingent on regulatory success, physician acceptance, and competitive dynamics.

4. How will pricing impact STOXIL’s commercial success?
Premium pricing justified by clinical benefits can enhance profitability but must be balanced against payer negotiations and reimbursement policies to maximize market access.

5. What are the primary risks facing STOXIL's market growth?
Key risks include regulatory delays, aggressive competitors, reimbursement restrictions, and patent disputes, all of which could impede revenue growth.


References

  1. [Insert epidemiology and market size reports]
  2. [Insert competitive analysis and industry forecasts]
  3. [Insert regulatory pathway guidelines]
  4. [Insert pricing and reimbursement studies]

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