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Last Updated: December 19, 2025

THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile


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When do Theophylline 0.2% And Dextrose 5% In Plastic Container patents expire, and what generic alternatives are available?

Theophylline 0.2% And Dextrose 5% In Plastic Container is a drug marketed by B Braun and is included in two NDAs.

The generic ingredient in THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER is theophylline. There are thirty-six drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the theophylline profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Theophylline 0.2% And Dextrose 5% In Plastic Container

A generic version of THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER was approved as theophylline by RHODES PHARMS on September 1st, 1982.

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Summary for THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
Drug patent expirations by year for THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
Recent Clinical Trials for THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER

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SponsorPhase
University of NebraskaPHASE1
Minia UniversityEARLY_PHASE1
Assiut UniversityPHASE1

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US Patents and Regulatory Information for THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
B Braun THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER theophylline INJECTABLE;INJECTION 019212-001 Nov 7, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER theophylline INJECTABLE;INJECTION 019826-004 Aug 14, 1992 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 Theophylline 0.2% and Dextrose 5% in Plastic Containers

Last updated: July 30, 2025


Introduction

The pharmaceutical landscape for intravenous (IV) solutions, particularly aqueous formulations like Theophylline 0.2% and Dextrose 5%, reflects evolving market forces driven by clinical demand, technological advancements, and regulatory shifts. These solutions, often administered via plastic containers such as IV bags, are integral to managing respiratory conditions, electrolyte imbalances, and metabolic disorders. This analysis explores the market dynamics influencing their growth and projects their financial trajectory within the global pharmaceutical market.


Market Overview

Product Profile and Applications

Theophylline, a bronchodilator, is primarily used in the management of chronic obstructive pulmonary disease (COPD) and asthma. Its IV formulation, such as Theophylline 0.2%, is reserved for acute or severe cases where oral administration is contraindicated. Dextrose 5%, a 5% dextrose solution, is a ubiquitous diluent and carbohydrate source in IV therapy, facilitating hydration, caloric support, and medication delivery.

These formulations are distributed in plastic containers, mainly polypropylene (PP) or polyvinyl chloride (PVC), tailored for patient safety, convenience, and compliance with sterile manufacturing standards. The global demand stems from hospitals, clinics, and home healthcare sectors, with a significant share in developing and developed economies.

Market Size and Forecasts

The IV solutions market, valued at approximately USD 15 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 6-8% over the next five years. The segment comprising Theophylline and Dextrose solutions is anticipated to sustain this growth trajectory, driven by expanding healthcare infrastructure, aging populations, and rising prevalence of respiratory and metabolic disorders.


Market Drivers

1. Increasing Prevalence of Respiratory Diseases

The global burden of COPD and asthma is rising, especially in Asia-Pacific and Middle East regions, amplifying demand for bronchodilators like Theophylline. Despite newer agents emerging, Theophylline remains part of therapeutic protocols owing to its affordability and well-established efficacy, especially in low-to-middle-income countries (LMICs).

2. Growing Incidence of Metabolic Disorders

The increasing incidence of diabetes and malnutrition highlights the reliance on dextrose infusions for hydration and nutritional support. The convenience of 5% dextrose solutions in plastic containers ensures consistent supply in hospitals and home-care settings.

3. Advancements in IV Container Technology

Plastic containers provide advantages such as lightweight design, reduced sterilization requirements, and compatibility with clinical workflows. Innovations in container material (e.g., sidewall thickness, additive-free polymers) improve shelf stability and safety, propelling market adoption.

4. Healthcare Infrastructure Expansion

Emerging markets exhibit significant investments in healthcare facilities, leading to increased procurement of IV solutions, including Theophylline and Dextrose in plastic packaging.

5. Regulatory and Manufacturing Trends

Stringent quality standards (e.g., USP, ISO) bolster confidence in plastic container products, encouraging manufacturers to enhance supply chain reliability and quality assurance, thus expanding market reach.


Market Challenges

1. Competition from Newer Therapeutics

Biologic agents and targeted therapies for respiratory and metabolic diseases are gradually displacing traditional drugs like Theophylline, which faces obsolescence concerns in certain regions.

2. Price Sensitivity and Cost Pressures

Especially in LMICs, price competitiveness influences procurement decisions, favoring manufacturers with cost-efficient production in plastic containers to maintain margins.

3. Supply Chain Disruptions

Global events such as pandemics or geopolitical conflicts can impede raw material procurement (e.g., plastics, pharmaceuticals), impacting production and distribution.

4. Regulatory Hurdles

Regulatory approvals for new formulations or container types may delay market entry and generate additional costs; compliance with environmental regulations on plastic waste remains challenging.


Financial Trajectory Analysis

Revenue Generation and Profitability

Given the market's projected CAGR of 6-8% over the next five years, revenues for Theophylline 0.2% and Dextrose 5% solutions in plastic containers are expected to increase correspondingly. Key factors influencing profitability include manufacturing efficiencies, scale economies, and strategic partnerships with healthcare providers.

Market Segmentation and Regional Trends

  • Developed Markets (North America, Europe): Emphasis on safety, quality, and regulatory compliance drives higher margins. The focus on injectable solutions in plastic containers aligns with hospital procurement strategies.

  • Emerging Markets (Asia-Pacific, Latin America): Rapid infrastructure growth and increasing healthcare access fuel demand. Price competition is fierce, but volume-driven sales support overall revenue gains.

Pricing Dynamics

Price points are influenced by raw material costs (plastic resins, active pharmaceutical ingredients), regulatory costs, and competition. Advances in container technology may enable premium pricing through improved safety and shelf life.

Investment and R&D Trends

Manufacturers investing in novel plastic container designs, robust sterilization methods, and supply chain resilience can secure competitive advantage and long-term revenue streams.


Future Outlook and Strategic Considerations

The trajectory for Theophylline 0.2% and Dextrose 5% in plastic containers is positive, contingent on the maintenance of clinical relevance and adaptability to market demands. Strategic focus should include:

  • Innovation: Developing eco-friendly, biodegradable plastic containers to address environmental concerns—a key differentiator.

  • Regulatory Navigation: Streamlining approvals across markets to accelerate product launches.

  • Market Diversification: Expanding distribution channels, including infusion pumps and automated dispensing units, enhances revenue stability.

  • Cost Optimization: Investing in manufacturing automation and supply chain efficiencies to sustain competitive pricing.


Key Market Trends Summary

  • Continual growth driven by healthcare infrastructure expansion and disease burden.
  • Increasing adoption of plastic containers due to safety and logistical advantages.
  • Marginal impact from newer drugs, maintaining niche relevance of Theophylline and Dextrose solutions.
  • Price sensitivity in emerging markets requires strategic cost management.
  • Environmental sustainability and regulatory standards becoming essential considerations.

Conclusion

The market for Theophylline 0.2% and Dextrose 5% solutions in plastic containers is poised for steady growth. While challenges such as technological competition and environmental regulations exist, innovation, strategic market positioning, and adherence to quality standards will underpin robust financial trajectories. Stakeholders should prioritize product differentiation and supply chain resilience to capitalize on expanding healthcare demand globally.


Key Takeaways

  • Growth prospects remain robust due to increasing respiratory and metabolic disorder prevalence.
  • Plastic containers offer safety, logistical, and marketing advantages, reinforcing their market position.
  • Price competition and regulatory compliance are critical for sustained profitability, especially in emerging markets.
  • Innovation in environmentally friendly packaging and container technology will shape future competitiveness.
  • Strategic investments in R&D and market expansion will maximize revenue potential over the coming years.

FAQs

Q1: How does the increasing adoption of biologic therapies impact the market for Theophylline and Dextrose solutions?

Biologics target specific pathways, often replacing traditional drugs like Theophylline. However, due to cost and accessibility, Theophylline remains relevant especially in LMICs. The market's growth will likely be driven by healthcare infrastructure and demand diversity, not solely by newer therapies.

Q2: What is the significance of plastic container technology in the market’s financial trajectory?

Plastic containers enhance safety, shelf stability, and logistics efficiency, making them preferred over glass, especially in hospital settings. They enable higher volume sales and support the development of integrated infusion systems, positively influencing revenue margins.

Q3: Are environmental concerns affecting the market for IV solutions in plastic containers?

Yes, there is increasing focus on eco-friendly packaging. Companies investing in biodegradable and recyclable plastics can mitigate regulatory risks and appeal to environmentally conscious markets, influencing future market dynamics.

Q4: Which regions are expected to show the fastest growth for these products?

Asia-Pacific and Latin America are projected to experience rapid growth due to expanding healthcare infrastructure and rising disease burden. Strategic entry into these markets can yield significant financial benefits.

Q5: What key regulatory considerations influence the financial trajectory of these IV solutions?

Compliance with international standards (e.g., USP, ISO) and local regulatory approvals directly impact market entry, timelines, and costs. Streamlined regulatory processes can accelerate revenue generation.


Sources:

[1] MarketsandMarkets. "Intravenous Solutions Market." 2022.
[2] GlobalData. "Respiratory Drugs Market Trends." 2023.
[3] Grand View Research. "Healthcare Packaging Market Analysis." 2022.
[4] World Health Organization. "Global Burden of COPD and Asthma." 2021.
[5] Euromonitor International. "Emerging Markets Healthcare Infrastructure." 2023.

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