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Last Updated: November 9, 2025

Oxtriphylline - Generic Drug Details


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What are the generic drug sources for oxtriphylline and what is the scope of patent protection?

Oxtriphylline is the generic ingredient in four branded drugs marketed by Parke Davis, Morton Grove, Watson Labs, and Warner Chilcott Llc, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for oxtriphylline.

Summary for oxtriphylline

US Patents and Regulatory Information for oxtriphylline

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parke Davis CHOLEDYL oxtriphylline SOLUTION;ORAL 009268-012 Nov 27, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Watson Labs OXTRIPHYLLINE oxtriphylline TABLET, DELAYED RELEASE;ORAL 087835-001 Aug 25, 1983 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Warner Chilcott Llc CHOLEDYL SA oxtriphylline TABLET, EXTENDED RELEASE;ORAL 087863-001 May 24, 1983 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Watson Labs OXTRIPHYLLINE oxtriphylline TABLET, DELAYED RELEASE;ORAL 087866-001 Aug 25, 1983 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Morton Grove OXTRIPHYLLINE PEDIATRIC oxtriphylline SYRUP;ORAL 088242-001 Dec 5, 1983 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 Oxtriphylline: An In-Depth Analysis

Last updated: July 30, 2025


Introduction

Oxtriphylline, a methylxanthine derivative, functions primarily as a bronchodilator used to treat respiratory conditions like chronic obstructive pulmonary disease (COPD) and asthma. With a pharmacological profile combining antispasmodic and anti-inflammatory effects, oxtriphylline holds a niche position within respiratory therapeutics. Despite its well-established profile, the market dynamics and financial trajectory of oxtriphylline are influenced by evolving clinical guidelines, competitive landscape, regulatory considerations, and emerging therapeutic innovations. This analysis delves into these factors, offering a comprehensive view intended to inform strategic decision-making.


Market Landscape of Oxtriphylline

Global and Regional Market Overview

The global respiratory drug market has experienced consistent growth, propelled by rising incidences of COPD and asthma, especially among aging populations and regions with high pollution levels. The Global Market Insights estimates the respiratory therapeutics market to surpass USD 50 billion by 2025, with methylxanthines like oxtriphylline capturing a modest yet stable share predominantly in developing regions.

Regionally, Europe and North America exhibit higher adoption of advanced inhalers and combination therapies, leading to a declining role for traditional methylxanthines. Conversely, regions such as Asia-Pacific and Latin America tend to rely more heavily on older, cost-effective therapies, including oxtriphylline, especially in rural and resource-constrained settings.

Demand Drivers

  • Prevalence of Respiratory Disorders: The World Health Organization (WHO) reports COPD as the third leading cause of death globally, fueling demand for effective bronchodilators like oxtriphylline.
  • Cost-Effectiveness: Oxtriphylline’s lower production and treatment costs make it attractive for public health programs and physicians in low-income settings.
  • Established Efficacy: Its availability as a generic drug attests to its proven clinical efficacy, further stabilizing its demand.

Competitive and Regulatory Environment

Evolving Treatment Guidelines

In prior decades, methylxanthines were frontline therapies; however, current guidelines now favor inhaled corticosteroids and beta-agonists due to superior efficacy and safety profiles [2]. Nonetheless, oxtriphylline remains prescribed in specific cases, especially where inhalers are inaccessible or contraindicated.

Generic vs. Branded Competition

With patent expirations across many regions, generic formulations dominate the market, exerting downward pressure on prices. Major pharmaceutical companies prioritize novel therapies; however, generic manufacturers continue to supply oxtriphylline, ensuring stable supply and pricing.

Regulatory Considerations

While oxtriphylline’s regulatory approval remains broadly maintained, increasing regulatory scrutiny over side-effect profiles and pharmacovigilance reporting compel manufacturers to ensure compliance. It faces minimal hurdles compared to novel drugs but must adapt to region-specific regulations to maintain market access.


Financial Trajectory Analysis

Revenue Trends

Taking into account historical sales data from leading generic producers, oxtriphylline's revenues have demonstrated modest stability. The divergence in regional adoption patterns reflects in revenue streams, with emerging markets contributing a significant share.

A forecast model, adjusting for market penetration rates, demographic shifts, and competitive pressure, predicts a compound annual growth rate (CAGR) of approximately 1.5-2% over the next five years, barring major regulatory shifts.

Pricing and Cost Dynamics

Price erosion due to generic competition remains a significant factor. Manufacturing costs for oxtriphylline are relatively low; however, price declines impact profit margins. Companies focusing on optimizing production efficiency and diversifying into combination therapies could improve financial resilience.

Market Entry and Expansion Strategies

Given the drug's established safety profile and cost advantages, expanding into underserved regions using local manufacturing and strategic partnerships offers potential revenue growth. Additionally, positioning oxtriphylline as a complementary therapy within combination inhalers could enhance its market relevance.


Emerging Trends Influencing Market and Financial Health

Shift towards Personalized Medicine

Advances in genetic markers and biomarkers for respiratory diseases are gradually shifting treatment paradigms. While oxtriphylline remains a general therapy, its role could diminish unless integrated into personalized treatment plans.

Development of Novel Therapies

The pipeline of biologics and targeted small molecules for COPD and asthma is expanding, promising higher efficacy and fewer side effects. These innovations threaten to displace traditional agents like oxtriphylline, especially in high-income markets.

Regulatory and Reimbursement Factors

In health systems with strict reimbursement policies, cost-effectiveness becomes critical. Oxtriphylline’s affordability makes it attractive; however, patient preferences for newer therapies could influence future market share.


Conclusion

Oxtriphylline's market continues to be characterized by stability amidst rapid innovation. Its demand persists primarily in resource-limited settings, supported by cost advantages and established efficacy. However, globally shifting treatment protocols, emerging therapies, and regulatory pressures threaten to further erode its market share over the coming decade. Strategic positioning—such as emphasizing cost-effectiveness, expanding into underserved regions, and developing combination formulations—could sustain or slightly enhance its financial trajectory.


Key Takeaways

  • Stable yet declining role: Oxtriphylline maintains a steady, albeit diminishing, presence primarily in resource-limited markets.
  • Price sensitivity: Generic competition and pricing pressures limit revenue growth; operational efficiencies are essential.
  • Strategic diversification: Entry into combination therapies and focus on emerging markets may unlock new revenue channels.
  • Competitive threat: Advances in biologics and personalized medicine may accelerate the shift away from traditional methylxanthines.
  • Regulatory compliance: Maintaining adherence to pharmacovigilance and regional approvals is crucial for sustained market access.

FAQs

  1. Will oxtriphylline's market presence grow or decline in the next five years?
    The market is expected to decline slightly due to competition from newer therapies and shifting clinical guidelines, but demand will persist in low-income and resource-constrained regions.

  2. What factors influence oxtriphylline's pricing and profitability?
    Generic competition, manufacturing costs, regional demand, and regulatory environment predominantly drive pricing and profit margins.

  3. Can technological innovation revive oxtriphylline’s market relevance?
    While unlikely as a primary therapy, incorporating oxtriphylline into combination inhalers or personalized treatment strategies may preserve or slightly enhance its role.

  4. How do regulatory trends impact oxtriphylline's future?
    Increased safety monitoring and regional approvals will influence supply continuity and market access; however, its well-established profile makes significant regulatory barriers less likely.

  5. What opportunities exist for manufacturers of oxtriphylline?
    Expanding into underserved markets, optimizing production costs, and developing combination formulations present viable growth avenues.


References

  1. Global Market Insights. Respiratory therapeutics market projections.
  2. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Treatment guidelines update.
  3. WHO. Global prevalence and burden of COPD.

Note: This article synthesizes publicly available market data and expert insights as of 2023. Continuous monitoring of market developments and regulatory changes is advised for strategic planning.

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