Last Updated: May 3, 2026

OXTRIPHYLLINE - Generic Drug Details


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What are the generic drug sources for oxtriphylline and what is the scope of freedom to operate?

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 SYRUP;ORAL 009268-011 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Warner Chilcott Llc CHOLEDYL SA oxtriphylline TABLET, EXTENDED RELEASE;ORAL 087863-001 May 24, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Morton Grove OXTRIPHYLLINE oxtriphylline SOLUTION;ORAL 088243-001 Dec 5, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Parke Davis CHOLEDYL oxtriphylline TABLET, DELAYED RELEASE;ORAL 009268-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Morton Grove OXTRIPHYLLINE PEDIATRIC oxtriphylline SYRUP;ORAL 088242-001 Dec 5, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

OXTRIPHYLLINE Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are Current Market Dynamics for Oxtriphylline?

Oxtriphylline, a xanthine derivative primarily used for respiratory conditions, has seen fluctuating demand influenced by evolving treatment guidelines, product availability, and competitive alternatives. The market for this drug remains niche, with limited growth prospects outside specialized respiratory therapy.

Market Size and Regional Distribution

Global market estimates place oxtriphylline’s valuation at approximately $50 million (USD) as of 2022, driven mainly by demand in India, China, and parts of Africa and Southeast Asia, where affordable respiratory therapies retain relevance. Developed regions such as North America and Europe exhibit minimal consumption, attributed to the dominance of newer bronchodilators and corticosteroids.

Competitive Landscape

Oxtriphylline competes with other methylxanthines like aminophylline and theophylline. These alternatives often demonstrate similar efficacy but differ in pharmacokinetics, safety profiles, and regulatory approval status. The availability of inhalers and combination therapies has reduced reliance on oral formulations like oxtriphylline.

Regulatory Environment

Regulatory approvals for oxtriphylline vary significantly. It remains approved in several countries as an off-patent generic; however, in the U.S., it lacks FDA approval for new indications or formulations. WHO listings facilitate use in low-resource settings but with limited promotional activities.

Market Drivers and Limiters

Key drivers include affordability, familiarity among clinicians, and established manufacturing processes. Limitations include the availability of more effective or safer inhaler-based medications, concerns over narrow therapeutic index, and lack of new clinical data supporting expanded indications.

How Is the Financial Trajectory Expected to Evolve?

Revenue Trends

Historical revenues have remained steady or declined slightly over the past decade. The global annual sales are estimated to be flat or marginally decreasing, with Compound Annual Growth Rate (CAGR) below 1% from 2017 to 2022.

Drivers of Financial Performance

The formulaic decline is driven by:

  • Obsolescence in developed markets due to new therapies.
  • Discontinuation or limited production of certain formulations.
  • Rising generic competition reducing prices.

In contrast, sales in emerging markets maintain a modest baseline owing to affordability and existing supply chains, but growth remains constrained by limited clinical trials and marginal regulatory updates.

Profitability and Cost Considerations

Manufacturers of oxtriphylline face low production costs owing to its status as a generic compound. Profit margins are compressed further by pharmaceutical pricing pressures and market saturation.

Future Outlook

No significant R&D investments are publicly documented for oxtriphylline. Its financial trajectory hinges on generic manufacturing, regional health policies, and the emergence of new respiratory therapies that could displace its use.

What Are the Key Factors Influencing the Market and Financial Outlook?

Factor Impact Notes
Competitive alternatives Negative Inhaled corticosteroids, bronchodilators
Regulatory policies Mixed Approval status varies globally
Investment in R&D Minimal No major recent developments
Regional healthcare policies Variable Emphasis on affordable, generic treatments in low-resource areas
Patient preferences Shifting Preference toward inhalers over oral formulations

Conclusions

Oxtriphylline’s market remains steady in specific low-resource settings but faces declining demand worldwide due to advances in inhalation therapies and safety concerns. Its financial performance is expected to stay flat, influenced by generic competition and limited innovation.

Key Takeaways

  • Market size is approximately $50 million globally, concentrated in emerging markets.
  • The drug faces competition from inhaled therapies that offer better safety profiles.
  • Sales and revenues have plateaued, with negligible growth projections.
  • Regulatory diversity affects its use, with limited promotional activity.
  • Future prospects depend on regional healthcare policies and the emergence of new respiratory treatments.

FAQs

1. Why is oxtriphylline still used despite competition?
Its low cost and established manufacturing make it an accessible option in resource-limited settings.

2. Are there ongoing efforts to develop new formulations of oxtriphylline?
No significant R&D activity has been reported for new formulations or potentiate clinical applications recently.

3. How does the safety profile of oxtriphylline compare to newer inhalers?
Oral oxtriphylline has a narrower therapeutic window, with risks of toxicity, unlike inhaled therapies with targeted delivery and fewer systemic effects.

4. Is oxtriphylline included in current treatment guidelines?
It is mentioned in some regional guidelines, primarily where access to inhalers is limited.

5. What factors could trigger a resurgence in oxtriphylline demand?
Major regulatory changes, patent issues with inhaled therapies, or significant cost advantages in specific markets could influence demand.


Sources:

  1. Market Research Future, "Global Xanthine Derivatives Market," 2022.
  2. GlobalData, "Respiratory Drugs Market Report," 2022.
  3. World Health Organization, "Essential Medicines List," 2019.
  4. U.S. FDA Drug Approvals Database.
  5. Pfizer and other patent filings.

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