DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Dianeal Low Calcium W/ Dextrose 1.5% In Plastic Container, and what generic alternatives are available?

Dianeal Low Calcium W/ Dextrose 1.5% In Plastic Container is a drug marketed by Vantive Us Hlthcare and is included in one NDA.

The generic ingredient in DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% 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.

Summary for DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

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

Sponsor	Phase
Yale University	NA
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NA
Iperboreal Pharma Srl	Phase 3

See all DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER clinical trials

Pharmacology for DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

Drug Class	Blood Coagulation Factor Calculi Dissolution Agent Osmotic Laxative Phosphate Binder
Mechanism of Action	Magnesium Ion Exchange Activity Osmotic Activity Phosphate Chelating Activity
Physiological Effect	Increased Coagulation Factor Activity Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Inhibition Small Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion

US Patents and Regulatory Information for DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% 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 LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	020183-001	Dec 4, 1992	AT	RX	Yes	No

DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER Market Analysis and Financial Projection

Last updated: February 16, 2026

What Are the Market Dynamics for DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER?

Dianeal low calcium with dextrose 1.5% is a peritoneal dialysis solution primarily used in kidney failure treatment. This segment is characterized by high clinical demand driven by increasing prevalence of chronic kidney disease (CKD), dialysis patient demographics, and evolving clinical guidelines.

Clinical and Demographic Drivers

• CKD and ESRD Rates: The global CKD prevalence exceeds 850 million, with an estimated 70 million patients requiring dialysis—mainly peritoneal dialysis (PD). The U.S. reports over 530,000 patients on dialysis, with PD accounting for approximately 10-15%.

• Aging Population: Patients over 65 account for more than 40% of dialysis populations globally, increasing demand for PD solutions like Dianeal.

• Clinical Preferences and Guidelines: Shifts favoring PD over hemodialysis (HD) due to better quality of life and lower costs support market growth.

Competitive Landscape

• Major Manufacturers: Baxter International is the primary supplier of Dianeal, holding approximately 60% of the global PD solutions market. Other competitors include manufacturers like Fresenius and Nipro, but their share is limited in the Dianeal segment.

• Product Differentiation: Dianeal's low calcium formulation targets specific patient needs, especially in post-surgical or hypercalcemic conditions.

Market Barriers

• Regulatory Challenges: Stringent approval processes across regions delay product launches. Changes in import regulations and local manufacturing mandates can impact availability.

• Pricing and Reimbursement: Healthcare payers' reimbursement policies impact sales volume, especially in markets with cost-control measures.

• Supply Chain Disruptions: Global sourcing of raw materials and packaging components affects production consistency.

What Is the Financial Trajectory for Dianeal Low Calcium W/ Dextrose 1.5%?

Revenue Trends

• Historical Growth: The PD solution segment, including Dianeal, has experienced a compound annual growth rate (CAGR) of roughly 4% from 2018 to 2022, driven by increased CKD diagnoses and dialysis uptake.

• Market Size: The global PD solutions market was valued at approximately $1.4 billion in 2022, with Dianeal representing around 45% of that, translating to roughly $630 million annually.

• Forecasted Growth: Projected CAGR of 3-4% through 2028 in the PD solutions segment. The segment's revenue could approach $1 billion annually within five years, assuming consistent growth.

Profitability Considerations

• Pricing Pressure: Payers seek volume discounts, pressuring manufacturers to lower prices, especially in mature markets like the U.S. and Europe.

• Cost Management: Baxter has invested in manufacturing efficiencies and supply chain optimization to preserve margins.

• R&D and Portfolio Diversification: Investments in new formulations and alternative therapies may impact margin allocation over time.

Regional Variations

• North America: Largest contributor due to high dialysis rate and reimbursement systems. Revenue expected to sustain growth, but subject to regulatory and policy shifts.

• EMEA and Asia-Pacific: Rapidly growing segments due to rising CKD prevalence and expanding healthcare infrastructure. Expected to contribute significantly to global sales growth.

Risks Impacting Financial Trajectory

• Market Saturation: Mature markets nearing saturation could limit growth prospects unless industry players innovate or expand into emerging markets.

• Regulatory Hurdles: Delays or additional requirements could slow product launches or lead to recalls.

• Competitive Pricing: Lower-cost alternatives or biosimilars may erode market share.

Key Takeaways

• The market for Dianeal low calcium with dextrose 1.5% in a plastic container is driven by rising CKD prevalence, aging populations, and clinical preference shifts.
• Baxter dominates the market, with a significant share, but faces competitive and regulatory challenges.
• Revenues are expected to grow modestly at 3–4% annually through 2028, with global sales potentially nearing $1 billion.
• Price pressures, supply chain risks, and regulatory policies remain key factors influencing financial performance.
• Rapid growth in emerging markets presents opportunities for expansion, but profit margins may be affected by regional reimbursement policies.

Frequently Asked Questions

1. What factors influence the pricing of Dianeal low calcium solutions?
   Reimbursement policies, manufacturing costs, market competition, and regional regulation impact pricing strategies.

2. How does CKD prevalence affect demand for PD solutions like Dianeal?
   Higher CKD prevalence increases dialysis needs, directly raising demand for PD solutions.

3. Are biosimilars or generic alternatives impacting Dianeal’s market share?
   While biosimilars are less common in this segment, low-cost alternatives and regional generics may pressure pricing and share, especially in cost-sensitive markets.

4. What regional markets offer the greatest growth potential?
   Asia-Pacific and Latin America exhibit rapid CKD growth and expanding healthcare infrastructure, representing substantial growth opportunities.

5. How might regulatory changes influence the future of Dianeal sales?
   Stricter approvals and labeling requirements could delay launches and impact availability, affecting future sales trajectories.

---

Citations

1. [1] Global CKD prevalence estimates, Kidney International Reports, 2021.
2. [2] Baxter's annual reports, 2018-2022.
3. [3] MarketsandMarkets, "Peritoneal Dialysis Market," 2022.
4. [4] U.S. Renal Data System, 2022 Annual Data Report.