Last Updated: May 11, 2026

DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER Drug Patent Profile


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When do Dianeal 137 W/ Dextrose 4.25% In Plastic Container patents expire, and what generic alternatives are available?

Dianeal 137 W/ Dextrose 4.25% In Plastic Container is a drug marketed by Vantive Us Hlthcare and is included in one NDA.

The generic ingredient in DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER is calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate. There are two hundred and eighty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate profile page.

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Questions you can ask:
  • What is the 5 year forecast for DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER?
  • What are the global sales for DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER?
Summary for DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
Recent Clinical Trials for DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

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SponsorPhase
Yale UniversityNA
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NA
Iperboreal Pharma SrlPhase 3

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US Patents and Regulatory Information for DIANEAL 137 W/ DEXTROSE 4.25% 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
Vantive Us Hlthcare DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 017512-002 Approved Prior to Jan 1, 1982 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

Market Dynamics and Financial Trajectory for DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

Last updated: February 16, 2026

Overview

Dianeal 137 W/ Dextrose 4.25% in plastic containers is a peritoneal dialysis (PD) solution used for renal replacement therapy. Its market presence hinges on the global prevalence of chronic kidney disease (CKD), technological innovations, regulatory environments, and competitive landscape.

Market Size and Growth Drivers

  • The global peritoneal dialysis market was valued at approximately $2.4 billion in 2022 and is projected to reach $4.1 billion by 2030, increasing at a compound annual growth rate (CAGR) of 7.6% [1].

  • The rising burden of CKD, linked to diabetes, hypertension, and aging populations, fuels demand for PD solutions, including Dianeal.

  • The shift from hemodialysis to peritoneal dialysis indoors and at home enhances the need for user-friendly, sterile PD solutions.

Pricing and Revenue Trends

  • Average wholesale prices (AWP) for Dianeal solutions vary globally, generally ranging from $8 to $15 per unit, with regional variations based on healthcare policies and purchasing power.

  • In major markets like the US and Europe, sales can reach hundreds of millions of dollars annually per product line.

  • Manufacturers such as Baxter International (the primary producer) reported dialysis product revenues of approximately $1.5 billion in 2022, with Dianeal accounting for a significant share.

Market Competition

  • Baxter's Dianeal faces competition from products by Fresenius Medical Care and Nikkiso, featuring similar PD solutions with varying formulations.

  • Patent expirations or regulatory exclusivities influence market share and pricing strategies.

  • Supply chain and manufacturing capacity are critical, especially given the need for sterile, single-use containers.

Regulatory and Reimbursement Environment

  • The US FDA approves PD solutions under strict safety and efficacy standards, affecting product launch timelines and costs.

  • Reimbursement policies from insurers and government programs like Medicare heavily influence sales volume.

  • International markets are subject to regional regulatory bodies (EMA, PMDA, etc.) with varying approval times and requirements.

Supply Chain and Production Dynamics

  • The pandemic underscored vulnerabilities in global medical supply chains, prompting manufacturers to diversify suppliers and increase inventories.

  • Baxter's manufacturing capability for Dianeal is robust, with a mix of regional production sites.

  • Packaging innovations, like pre-filled sterile containers, bolster product safety and ease of use, impacting market adoption.

Financial Trajectory

  • Given the market size and growth rate, Dianeal’s global sales are expected to grow at a CAGR of approximately 5-8% over the next five years, when accounting for market penetration and technological advancements.

  • Investment in R&D for improved biocompatibility and optimized infusion profiles is likely to sustain product relevance and justify premium pricing.

  • The ongoing patent landscape indicates that Baxter’s formulations and delivery systems may have patent protections through the late 2020s, potentially supporting revenue margins.

Key Risks and Opportunities

  • Risks include regulatory delays, competitive innovations, and shifts in reimbursement policies.

  • Opportunities stem from expanding into emerging markets, developing next-generation solutions with improved biocompatibility, and integrating digital health tools to improve patient adherence.

Conclusion

Dianeal 137 W/ Dextrose 4.25% is positioned in a growing global market driven by increasing CKD prevalence and the adoption of peritoneal dialysis. Revenue growth hinges on regulatory navigation, technological innovation, and supply chain management. Competitive dynamics remain intense, with strategic positioning critical for market share retention.


Key Takeaways

  • The global peritoneal dialysis market is expected to grow at 7.6% CAGR, with Dianeal being a significant player.

  • Revenues are influenced by regional pricing, reimbursement policies, and competition.

  • Product innovation and supply chain resilience are vital to maintaining market position.

  • Regulatory approvals and patent protections shape the financial outlook.

  • Long-term growth depends on expansion into emerging markets and technological enhancements.


FAQs

1. What factors influence the pricing of Dianeal solutions globally?
Pricing varies based on regional healthcare policies, regulatory approval costs, reimbursement rates, and competition, which collectively determine the final consumer and provider prices.

2. How does Baxter's market share impact Dianeal's revenue potential?
Baxter's dominant position allows for pricing power and investment in product innovation, influencing revenue stability and growth prospects.

3. What are the main technological advancements expected in PD solutions?
Upcoming innovations focus on biocompatible solutions, pre-filled sterile containers, and integration with digital health tools for remote monitoring.

4. How do regulatory environments affect Dianeal's market trajectory?
Regulatory approval times, safety standards, and compliance costs affect product launch schedules and profitability across different regions.

5. What is the impact of patent expirations on Dianeal's market?
Patent expirations could lead to generic or biosimilar competition, reducing prices and revenues unless protected by additional intellectual property or technological barriers.


Sources

[1] Global Peritoneal Dialysis Market Report, 2022.

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