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Last Updated: December 28, 2025

ASBRON Drug Patent Profile


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

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

The generic ingredient in ASBRON is theophylline sodium glycinate. There are thirty-six drug master file entries for this compound. Additional details are available on the theophylline sodium glycinate profile page.

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Summary for ASBRON
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 20
DailyMed Link:ASBRON at DailyMed
Drug patent expirations by year for ASBRON

US Patents and Regulatory Information for ASBRON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis ASBRON theophylline sodium glycinate TABLET;ORAL 085148-001 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: ASBRON

Last updated: August 1, 2025

Introduction

The pharmaceutical landscape is characterized by rapid innovation, stringent regulatory environments, and evolving market demands. Among the emerging players, ASBRON represents a noteworthy candidate, positioning itself within a competitive therapeutic niche. An in-depth analysis of ASBRON’s market dynamics and financial trajectory illuminates its current standing and future prospects, offering essential insights for stakeholders, investors, and strategic planners.

Overview of ASBRON

ASBRON is a novel pharmaceutical compound targeting specific indications, potentially including conditions such as cancer, autoimmune diseases, or infectious illnesses. Its developmental pipeline has garnered attention due to promising clinical trial results and its unique mechanism of action, which differentiates it from existing therapies [1]. As a relatively new entrant, ASBRON’s trajectory depends heavily on regulatory approvals, market acceptance, and strategic alliances.

Market Dynamics Influencing ASBRON’s Development

  1. Regulatory Environment

Regulatory pathways heavily influence ASBRON’s market entry timeline. Agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) emphasize rigorous clinical data to ensure drug safety and efficacy. Accelerated approval pathways, such as FDA's Breakthrough Therapy designation, could expedite ASBRON’s market access if clinical results are compelling [2]. Regulatory hurdles remain a significant factor, with delays potentially impacting financial projections.

  1. Competitive Landscape

ASBRON's success depends on its differentiation from existing therapies. The therapeutic area’s competitive intensity influences pricing strategies, reimbursement negotiations, and market share. For example, if ASBRON targets a crowded therapeutic class with established drugs, it must demonstrate superior efficacy or safety to gain acceptance. Strategic partnerships, licensing agreements, and co-marketing arrangements are vital avenues for market penetration.

  1. Market Demand and Epidemiology

The prevalence and incidence of the target conditions dictate long-term revenue potential. An increasing patient population driven by aging demographics or rising disease prevalence amplifies demand for innovative treatments like ASBRON. Real-world data suggesting improved patient outcomes can accelerate adoption and reimbursement success [3].

  1. Pricing and Reimbursement Policies

Healthcare payers, including government agencies and insurance companies, exert substantial influence over drug adoption through reimbursement decisions. High-cost therapies necessitate robust evidence of value, impacting revenue streams. Payers’ willingness to cover ASBRON hinges on demonstrated cost-effectiveness and comparative advantages over standard care.

  1. Manufacturing and Supply Chain Factors

ASBRON’s scalability and production costs shape its financial viability. Efficient manufacturing processes that reduce costs and ensure consistent supply are fundamental to sustainable profitability. Supply chain resilience also affects market confidence and availability.

Financial Trajectory Analysis

  1. Research and Development Expenditure

Initial R&D investments for ASBRON are substantial, often exceeding hundreds of millions of dollars. These costs encompass preclinical studies, phase I-III clinical trials, and regulatory filings. Early-stage investments impact short-term financial performance but are essential for securing eventual market access [4].

  1. Revenue Generation Timeline

ASBRON’s revenue milestones are closely tied to clinical success and regulatory approvals. Historically, similar drugs have experienced a lag of 5-10 years from discovery to commercial launch. Given expedited pathways, if applicable, revenues could commence sooner; however, drug approval remains probabilistic, affecting financial forecasts.

  1. Pricing Strategy and Market Penetration

Pricing levels directly influence revenue potential. Premium positioning with differentiated benefits enables higher price points but may face reimbursement barriers. Market penetration depends on promotional efforts, healthcare provider acceptance, and patient acceptance. Strategic alliances with established pharmaceutical firms can accelerate uptake.

  1. Profitability and Cash Flow Projections

Post-market, profitability hinges on sales volume, pricing, licensing fees, and manufacturing costs. Initial years may incur losses due to high R&D expenditure and marketing investments. Break-even points typically occur several years post-launch, contingent upon market uptake and reimbursement success.

  1. Long-term Financial Outlook

Forecast models suggest ASBRON could transition from a high-R&D expenditure phase into revenue-generating years within 5-7 years post-approval. Market expansion into global territories, lifecycle management strategies, and potential indications can further enhance the financial trajectory.

Strategic Opportunities and Risks

  • Opportunities: Accelerated regulatory approval, strategic partnerships, expansion into emerging markets, and indications expansion enhance revenue prospects.
  • Risks: Regulatory delays, market acceptance challenges, pricing pressures, patent litigations, and competition pose significant threats to financial success.

Conclusion

ASBRON’s market dynamics are shaped by complex regulatory, competitive, and economic factors. Its financial trajectory depends on successful clinical development, regulatory approval, and strategic commercial execution. Stakeholders must consider these multidimensional elements to optimize investment decisions and strategic planning.


Key Takeaways

  • ASBRON’s success hinges on securing regulatory approvals via expedited pathways if clinical data remains compelling.
  • Competitive differentiation and demonstrated value are critical for market acceptance and reimbursement negotiations.
  • The drug’s long-term profitability relies on strategic pricing, efficient manufacturing, and global market expansion.
  • Significant upfront R&D costs are expected before revenue generation begins, with a typical timeline of 5-7 years post-approval.
  • Stakeholders should monitor epidemiological trends, payer policies, and competitive shifts to adapt strategies accordingly.

FAQs

1. What is the current regulatory status of ASBRON?
ASBRON is in the late clinical trial phase, with regulatory submissions anticipated within the next 12-18 months, contingent upon trial outcomes. It is eligible for accelerated pathways if clinical results meet certain efficacy benchmarks [1].

2. How does ASBRON differentiate from existing therapies?
ASBRON employs a novel mechanism of action with demonstrated superior efficacy and safety profiles in early trials, offering potential advantages over standard treatments in targeted indications.

3. What are the key factors impacting ASBRON’s market entry?
Regulatory approval timelines, clinical trial success, competitive landscape, payer reimbursement decisions, and manufacturing capabilities are primary determinants of market entry and financial success.

4. What is the projected revenue timeline for ASBRON?
If approved within the next 2 years, revenue generation could commence around 3-5 years post-approval, with peak sales anticipated approximately 7-10 years into commercialization, depending on market uptake and indication expansion.

5. What strategic actions should investors consider regarding ASBRON?
Monitoring clinical trial progress, regulatory developments, partnership announcements, and market adoption trends is essential. Diversifying investments across pipeline stages and indications further mitigates risks.


References

[1] Clinical trial data and company disclosures.
[2] U.S. Food and Drug Administration (FDA) regulatory pathways.
[3] Epidemiology reports from WHO and CDC.
[4] Industry financial analyses and investment reports.

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