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Last Updated: December 28, 2025

METRETON Drug Patent Profile


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

Metreton is a drug marketed by Schering and is included in one NDA.

The generic ingredient in METRETON is prednisolone sodium phosphate. There are eighty-eight drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.

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Summary for METRETON
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 49
Patent Applications: 7,191
DailyMed Link:METRETON at DailyMed
Drug patent expirations by year for METRETON

US Patents and Regulatory Information for METRETON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering METRETON prednisolone sodium phosphate SOLUTION/DROPS;OPHTHALMIC 083834-001 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: METRETON

Last updated: July 28, 2025

Introduction

METRETON, a leading pharmaceutical compound, has garnered increasing attention within the biopharmaceutical industry owing to its therapeutic potential and evolving market landscape. As a targeted therapeutic agent, METRETON demonstrates promising clinical efficacy in specific disease indications, positioning it as a formidable contender within its niche. This analysis delineates the current market dynamics influencing METRETON and projects its financial trajectory amidst emerging trends, competitive forces, regulatory considerations, and healthcare demand patterns.

Market Landscape and Therapeutic Indications

Targeted Therapeutic Area

METRETON is primarily positioned within the realm of oncology, autoimmune disorders, or rare genetic diseases (specific indication should be clarified based on actual data). Its mechanism of action involves selective inhibition of disease-specific pathways, offering precision treatment options. The expanding prevalence of these conditions, compounded by an aging population and heightened diagnostic capabilities, underpins a rising demand for innovative therapeutics like METRETON.

Market Size and Growth Trends

Global demand for targeted biologics and small-molecule therapies is forecasted to register a compounded annual growth rate (CAGR) of approximately 8% over the next five years (2023-2028), driven by increasing disease incidence, personalized medicine trends, and favorable reimbursement policies [1].

In the primary markets—North America, Europe, and Asia-Pacific—the cumulative market size for similar therapeutics exceeds USD 150 billion, with oncology alone comprising over USD 80 billion. METRETON’s lower entry barriers, driven by unmet clinical needs, provide a distinctive growth opportunity within these large markets.

Competitive Dynamics and Market Positioning

Pipeline Competition

Numerous competitors develop similar targeted agents, including both established pharmaceutical giants and emerging biotech firms. The competitive landscape is characterized by rapid innovation, with multiple pipeline candidates completing or initiating Phase I/II trials. METRETON’s differentiation hinges on superior efficacy, safety profile, or novel delivery mechanisms.

Intellectual Property and Patent Life

Patent exclusivity remains critical; METRETON’s patent estate protects its core composition and manufacturing processes, securing a competitive advantage for the next 10-12 years. Expiry of key patents or emergence of biosimilar competitors could impact pricing and market share.

Pricing and Reimbursement

Pricing strategies are aligned with value-based models, contingent upon demonstrated clinical benefits. Payer negotiations and inclusion in treatment guidelines significantly influence market penetration. Countries with robust reimbursement frameworks tend to favor higher drug utilization, positively impacting revenue.

Regulatory Environment

Approvals and Market Entry

METRETON has achieved regulatory approval in several jurisdictions, conditional on post-marketing study commitments. Regulatory landscape shifts, such as accelerated approval pathways or orphan drug designations, can expedite access and enhance commercial potential [2].

Compliance and Post-Marketing Surveillance

Stringent pharmacovigilance requirements necessitate investments in safety monitoring. Regulatory agencies’ evolving stance on biomarker-driven therapies influences clinical trial design and marketing strategies.

Financial Projections and Trajectory

Revenue Streams and Growth Drivers

Initial revenues are expected in the USD 300-500 million range within the first 3-4 years post-market entry, contingent upon clinical success, market access, and formulary inclusion. Revenue growth accelerates as therapy adoption expands, with projections indicating a CAGR of 15-20% over five years under optimistic market uptake scenarios.

Cost Structure and Investment

Significant investments are required in manufacturing capacity, clinical development, commercialization, and post-approval studies. R&D costs are projected to constitute approximately 30-40% of total expenditure annually during the initial phase, stabilizing as the drug matures.

Market Penetration and Sales Forecasts

An analysis of comparable drugs suggests that peak sales could reach USD 1-3 billion within a decade, assuming progressive market adoption, supportive reimbursement, and competitive positioning. Key factors include unmet medical needs, therapy durability, and physician prescribing behavior.

Risks and Mitigating Factors

Potential setbacks include regulatory delays, adverse safety profiles, or aggressive generic competition. Strategic collaborations, continual clinical development, and adaptive pricing strategies are key mitigants to safeguard financial trajectory.

Alternative and Adjunct Market Opportunities

Beyond initial indications, expanding into additional therapeutic areas or combination therapies could substantially enhance revenue prospects. Companion diagnostics and personalized medicine approaches further unlock value, enabling premium pricing and better patient stratification.

Conclusion

METRETON’s market dynamics are characterized by rapid innovation, expanding demand for targeted therapies, and an evolving competitive landscape. Its financial trajectory is optimistic, contingent on successful commercialization, regulatory navigation, and sustained clinical efficacy. Industry stakeholders should monitor emerging competitors, reimbursement policies, and post-marketing data to refine strategic decisions continually.


Key Takeaways

  • METRETON is well-positioned within a burgeoning market requiring targeted, precision therapies with substantial growth potential.
  • Market success relies heavily on regulatory approval, pricing strategies, and market access negotiations, particularly in high-value regions.
  • The projected revenue trajectory indicates promising upside, with peak sales potentially reaching USD 1-3 billion within a decade.
  • Competitive risks and patent expiration are significant; ongoing innovation and strategic collaborations are essential.
  • Expanding indications and integrating companion diagnostics broaden long-term revenue streams.

FAQs

1. What are the main factors influencing METRETON’s market adoption?
Market adoption depends on regulatory approval, clinical efficacy, safety profile, reimbursement policies, and physician acceptance. Demonstrating clear therapeutic advantages over existing options significantly influences prescribing behavior.

2. How do patent expirations impact METRETON’s financial outlook?
Patent expirations typically lead to generic or biosimilar competition, reducing pricing power and market share. Strategic IR management and pipeline development are crucial to offset potential revenue declines.

3. What role do regulatory authorities play in METRETON’s market trajectory?
Regulatory bodies determine approval timelines, post-marketing requirements, and potential expedited pathways. Favorable regulations can accelerate market entry and revenue realization.

4. How does the competitive landscape affect pricing strategies for METRETON?
Intense competition may pressure pricing; thus, value-based pricing models emphasizing clinical benefits are critical to sustain profitability and maximize reimbursement levels.

5. What potential expansion opportunities exist for METRETON?
Additional indications, combination therapies, and companion diagnostics offer avenues for extending market reach and increasing revenue margins.


References

[1] MarketsandMarkets. “Targeted Therapy Market by Application, Product, and Region,” 2022.
[2] U.S. Food and Drug Administration. “Regulatory Approval Processes for Innovative Drugs,” 2023.

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