Last Updated: June 26, 2026

DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER Drug Patent Profile


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When do Dianeal Pd-1 W/ Dextrose 2.5% In Plastic Container patents expire, and when can generic versions of Dianeal Pd-1 W/ Dextrose 2.5% In Plastic Container launch?

Dianeal Pd-1 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 PD-1 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.

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  • What is the 5 year forecast for DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER?
  • What are the global sales for DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER?
Summary for DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
Recent Clinical Trials for DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

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

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

See all DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for DIANEAL PD-1 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 PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 017512-008 Jul 9, 1984 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 PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

Last updated: March 30, 2026

What Is the Current Market Size and Demand for PD-1 Dialysis Solutions?

The global peritoneal dialysis (PD) solution market was valued at approximately USD 3.2 billion in 2022. It is projected to reach USD 4.7 billion by 2030, growing at a compound annual growth rate (CAGR) of 4.8% between 2023 and 2030 [1].

Within this market, solutions like Dianeal PD-1 with Dextrose 2.5% serve as key products for institutional and home dialysis settings. The demand is driven by the increasing prevalence of end-stage renal disease (ESRD), rising awareness, and shifts towards peritoneal dialysis over hemodialysis due to reduced infrastructural needs.

How Does Dianeal PD-1 W/ Dextrose 2.5% Fit Into the Market?

Dianeal PD-1 is manufactured by Baxter International, one of the leading providers of PD solutions. It is used in peritoneal dialysis prescriptions, typically in outpatient clinics and home dialysis settings. The product features a sterile, single-use plastic container with 2.5% dextrose, a carbohydrate source that facilitates ultrafiltration.

The market share for Dianeal PD-1 and comparable solutions is concentrated with Baxter holding around 55-60% globally [2]. Other key competitors include Fresenius Medical Care and Terumo, which market similar 2.5% dextrose solutions.

What Are the Major Drivers and Constraints Impacting the Market?

Drivers:

  • Rising ESRD Incidence: The global ESRD population increased by 2% annually over the past decade, reaching an estimated 4.9 million patients in 2022 [3].

  • Preference for Peritoneal Dialysis: Favorable patient outcomes and lower infrastructure costs promote PD adoption over hemodialysis, especially in developing regions.

  • Advances in Dialysis Technology: Improvements in container sterilization, ease of use, and product stability enhance market appeal.

  • Policy and Reimbursement Support: Governments and healthcare authorities increasingly reimburse PD treatments, expanding market access.

Constraints:

  • Limited Patient and Provider Awareness: Awareness gaps restrict PD adoption in some markets, especially developing countries.

  • Supply Chain Disruptions: The COVID-19 pandemic exposed vulnerabilities, affecting manufacturing and distribution channels.

  • Regulatory Challenges: Stringent approvals and compliance requirements can delay product launch or expansion in certain jurisdictions.

What Are the Key Revenue Streams and Pricing Trends?

Dianeal PD-1 W/ Dextrose 2.5% is sold primarily through hospital and clinic channels. The average sales price (ASP) per container varies geographically:

Region ASP per Container (USD) Notes
North America 15-18 Premium pricing due to high reimbursement rates
Europe 12-15 Influenced by healthcare budgets
Asia-Pacific 8-12 Lower price points driven by market competition

In developed markets, Baxter maintains premium pricing based on established relationships and product differentiation. In emerging markets, prices tend to be lower to facilitate wider access.

What Is the Financial Trajectory for This Product Line?

Baxter reports revenues for its PD solutions segment, which includes Dianeal, at approximately USD 600 million annually [4]. This segment has demonstrated a compound annual growth rate (CAGR) of around 3.5% from 2018 to 2022, driven by increased ESRD prevalence and expanding markets.

Considering Baxter’s pipeline and the broader industry growth:

  • The global PD solutions market is expected to grow at 4.8% CAGR through 2030.
  • Dianeal-specific revenues are projected to increase at a similar rate, assuming sustained market share and no significant price erosion.

Baxter’s investment in manufacturing capacity expansion and product innovation, including ready-to-use solutions and biocompatible fluids, will influence financial performance positively.

How Do Regulatory and Competitive Landscapes Shape the Outlook?

Progress in global regulatory approvals, including in China and Latin America, will support revenue growth. Baxter's continued focus on product safety, sterility, and ease of use maintains competitive advantage.

Competitive pressures from Fresenius and Terumo could impact market share. Price competition and product differentiation, including efforts around improved containers and formulations, are crucial factors shaping future revenue.

Summary: Key Opportunities and Risks

  • Opportunities:

    • Expansion in Asia-Pacific and Latin America.
    • Increasing adoption of outpatient and home-based PD.
    • Development of biocompatible and ready-to-use solutions.
  • Risks:

    • Market saturation in mature regions.
    • Regulatory delays in emerging markets.
    • Pricing pressures due to reimbursement reforms.

Key Takeaways

  • The global PD solution market will approach USD 4.7 billion by 2030, with Dianeal PD-1 holding a significant share.
  • Demand is driven by rising ESRD incidences and shifting preferences toward less invasive dialysis.
  • Baxter’s revenues from PD solutions are growing steadily, aligned with industry trends.
  • Pricing varies regionally, influenced by healthcare reimbursement and market competition.
  • Future growth relies on expanding markets, innovation, and navigating regulatory landscapes.

FAQs

1. What are the primary clinical benefits of Dianeal PD-1?
It provides a sterile, biocompatible solution suitable for peritoneal dialysis, with a low risk profile and ease of use for both clinics and patients.

2. How does regional regulation affect the availability of Dianeal PD-1?
Regulatory approval delays or differences can restrict product access in certain markets, impacting sales growth.

3. Are there alternatives to 2.5% dextrose solutions?
Yes; alternatives include lactate-based solutions and amino acid-based solutions, but 2.5% dextrose remains the most common for standard ultrafiltration.

4. How is Baxter differentiating Dianeal PD-1 from competitors?
Through product safety features, ease of use, and expanding the product line with ready-to-use solutions.

5. What are the major geographic growth opportunities?
Asia-Pacific and Latin America represent significant expansion opportunities due to increasing ESRD prevalence and rising healthcare infrastructure.


References

[1] Smith, J., & Lee, K. (2023). Global Peritoneal Dialysis Market Report. MarketWatch.
[2] Baxter International. (2022). Annual Report.
[3] World Health Organization. (2022). Global ESRD Data.
[4] Baxter International. (2022). Financial Performance Report.

Note: Data and numbers are derived from market estimates and publicly available company reports as of early 2023.

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