Last Updated: May 11, 2026

DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Dianeal 137 W/ Dextrose 2.5% In Plastic Container patents expire, and what generic alternatives are available?

Dianeal 137 W/ Dextrose 2.5% 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 2.5% 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.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER?
  • What are the global sales for DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER?
Summary for DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
Recent Clinical Trials for DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

Identify potential brand extensions & 505(b)(2) entrants

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

See all DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for DIANEAL 137 W/ DEXTROSE 2.5% 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
Vantive Us Hlthcare DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 017512-003 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 2.5% IN PLASTIC CONTAINER

Last updated: February 15, 2026

Overview

Dianeal 137W with Dextrose 2.5% in plastic containers is a peritoneal dialysis (PD) solution manufactured by Baxter International. Its market presence is primarily in dialysis centers, hospitals, and home care sectors. The product is a component of peritoneal dialysis treatment, a modality growing amidst rising chronic kidney disease (CKD) prevalence. Baxter has historically dominated this market segment, benefiting from robust distribution channels and established clinical protocols.

Market Size and Growth Drivers

The global PD fluids market was valued at approximately USD 1.5 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of about 4–6% over the next five years. Key drivers include:

  • Rising CKD Incidence: The World Health Organization estimates CKD affects over 850 million people worldwide. Increasing cases translate into higher demand for dialysis solutions, including Dianeal.

  • Shift Toward Home Dialysis: Patients and providers adopt peritoneal dialysis as an alternative to hemodialysis due to convenience, lower infrastructure costs, and safety concerns related to in-center treatment, especially post-COVID-19.

  • Enhanced Product Adoption: Baxter’s product positioning, clinical preferences, and reimbursement attractiveness for PD solutions influence market share stability and growth.

Competitive Landscape

Major competitors include Fresenius Kabi and B. Braun. While Baxter holds a significant share, market dynamics are influenced by:

  • Product Differentiation: Baxter's Dianeal is a well-established product, often bundled with training, remote monitoring, and support services.

  • Pricing Strategies: Price competition remains moderate, with Baxter’s dominant position allowing for premium pricing in many markets.

  • Regulatory Developments: Approvals and compliance standards (particularly in the U.S. FDA and EMA jurisdictions) influence the product's availability and market penetration.

Pricing and Revenue Projections

Dianeal's pricing varies across geographies due to reimbursement differences:

Region Approximate Price per Container (USD) Comments
United States $50–$70 Reimbursement-driven pricing
Europe €40–€55 EU reimbursement schemes
Asia-Pacific $30–$50 Cost sensitivity, local manufacturing

Assuming Baxter maintains a global shipped volume of roughly 10 million units annually and capturing approximately 70% of the PD fluid market, revenue from Dianeal alone could be estimated at USD 350–490 million annually.

Financial Trajectory

  • Historical Growth: Baxter’s dialysis division, including Dianeal, has experienced revenue growth averaging 3–4% annually over the past five years, driven by increased CKD prevalence and market expansion.

  • Forecasts: With continued epidemiological growth and market penetration, revenues could expand at an annual rate of approximately 5–6% over the next five years, barring significant market disruptions.

  • Margin Trends: Gross margins for Baxter’s dialysis products typically range between 40 and 50%. Cost reductions in manufacturing, especially through local production in high-demand regions, could improve profitability.

  • Impact of Biosimilars and Generics: While biosimilar alternatives are not currently prevalent for Dianeal, regional policies favoring cost reductions could pressure pricing, impacting margins.

Regulatory and Policy Factors

Reimbursement policies directly impact sales volume and pricing:

  • United States: Medicare and private insurers reimburse based on dialysis-specific bundling codes; reimbursement rates influence patient and facility adoption.

  • European Union: Reimbursement varies by country; some nations have moved toward value-based models, pressuring manufacturers to lower prices.

  • Emerging Markets: Governments are increasingly adopting procurement policies favoring local manufacturing or generic equivalents, which could challenge Baxter’s pricing strategy.

Supply Chain and Manufacturing Considerations

Baxter’s production flexibility and regional manufacturing hubs mitigate supply chain risks:

  • Regional manufacturing facilities: In the US, Europe, Japan, and China, reduce tariffs and lead times.

  • Material costs: Plastic container prices have been stable but are susceptible to global polymer market fluctuations.

  • Regulatory approvals: New indications and formulations require compliance, potentially affecting supply timelines and cost structures.

Risks and Opportunities

  • Risks: Market saturation, regulatory barriers, pricing pressures, and competitive entries could suppress growth.

  • Opportunities: Expansion into emerging markets, development of adjunct dialysis products, and adoption of new packaging formats (e.g., multi-chamber systems) could drive future revenues.

Key Takeaways

  • The global market for PD solutions is growing at 4–6%, driven by rising CKD prevalence and dialysis shift towards home care.

  • Baxter’s Dianeal maintains a dominant position, with revenues potentially reaching USD 350–490 million annually, assuming stable market share and volume.

  • Pricing varies by region; margins are influenced by reimbursement policies, competition, and manufacturing costs.

  • Regulatory developments and regional policies will significantly influence growth potential.

  • Supply chain resilience and innovation in product formats represent strategic opportunities.

5 FAQs

  1. What is the current market share of Baxter for Dianeal?
    Baxter holds approximately 70% of the global PD fluids market, primarily accounting for Dianeal’s sales.

  2. How does the rise of biosimilars impact Dianeal’s market?
    Biosimilar alternatives for PD solutions are limited globally; however, some regional markets may eventually introduce lower-cost options, which could affect pricing and volume.

  3. What are the primary risks to Dianeal’s financial growth?
    Market saturation, regulatory hurdles, reimbursement shifts, and aggressive pricing from competitors represent key risks.

  4. Are there new formulations or packaging innovations in the pipeline?
    Companies are exploring multi-chamber systems for improved stability and ease of use, along with single-use, multi-lumen containers to enhance safety.

  5. How does regional regulation influence Dianeal’s sales?
    Stringent approval processes, regional reimbursement policies, and local manufacturing approvals can delay product availability or affect pricing strategies.

Sources

  1. MarketsandMarkets. "Peritoneal Dialysis Market by Type, Application, Region - Global Forecast to 2025."
  2. World Health Organization. "Global CKD Prevalence."
  3. Baxter Investor Relations. "Dialysis and Nephrology Product Overview."
  4. IMS Health Reports on Dialysis Market Pricing.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.