DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER Drug Patent Profile

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When do Dianeal Low Calcium W/dextrose 3.5% In Plastic Container patents expire, and when can generic versions of Dianeal Low Calcium W/dextrose 3.5% In Plastic Container launch?

Dianeal Low Calcium W/dextrose 3.5% 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 3.5% IN PLASTIC CONTAINER is calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate. There is one drug master file entry for this compound. Three 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 3.5% 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 3.5% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for DIANEAL LOW CALCIUM W/DEXTROSE 3.5% 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 3.5% IN PLASTIC CONTAINER clinical trials

Pharmacology for DIANEAL LOW CALCIUM W/DEXTROSE 3.5% 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 Acidifying 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 3.5% 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 3.5% IN PLASTIC CONTAINER	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	017512-014	Jul 11, 1990		RX	Yes	No

DIANEAL Low Calcium With Dextrose 3.5% Market Dynamics, Patent Position, and Financial Trajectory

Last updated: October 8, 2026

DIANEAL Low Calcium With Dextrose 3.5% in Plastic Container is a peritoneal dialysis solution marketed by Baxter Healthcare Corporation. Its commercial position is tied to the recurring peritoneal dialysis consumables market rather than to conventional prescription-drug pricing. Demand is driven by the installed base of automated and continuous ambulatory peritoneal dialysis patients, dialysis-center protocols, home-care adoption, supply reliability, and reimbursement.

The product has limited apparent patent-based exclusivity. Its principal defenses are manufacturing know-how, validated sterile production, regulatory compliance, distribution capacity, physician familiarity, and integration with peritoneal dialysis systems. Product-level revenue is not separately disclosed by Baxter. Financial exposure must therefore be assessed through Baxter’s former Kidney Care business, now Vantive following the sale of the business to Carlyle.

What is DIANEAL Low Calcium With Dextrose 3.5%?

DIANEAL Low Calcium With Dextrose 3.5% is a sterile peritoneal dialysis solution containing dextrose as the osmotic agent and reduced calcium concentration for intraperitoneal administration. It is supplied in plastic containers and is used in patients receiving peritoneal dialysis for renal replacement therapy.

The 3.5% dextrose concentration provides a higher osmotic load than lower-dextrose formulations. The low-calcium formulation is intended for patients for whom dialysate calcium management is clinically appropriate. Product selection depends on the patient’s volume status, serum calcium, dialysis prescription, residual renal function, and treatment modality.

Product profile

Attribute	Product description
Brand	DIANEAL
Formulation	Low-calcium peritoneal dialysis solution
Dextrose concentration	3.5%
Dosage form	Sterile dialysate solution
Route	Intraperitoneal
Container	Plastic container
Primary use	Peritoneal dialysis
Manufacturer	Baxter Healthcare Corporation
Commercial category	Renal-care consumable and prescription dialysis product

FDA labeling identifies DIANEAL as a peritoneal dialysis solution indicated for patients with acute or chronic renal failure when peritoneal dialysis is clinically appropriate.[1]

What is the FDA regulatory status of DIANEAL Low Calcium 3.5%?

DIANEAL is an FDA-approved prescription dialysis solution marketed under a new drug application. Baxter’s product labeling includes composition, indications, contraindications, warnings, handling requirements, and administration instructions.[1]

The product is subject to pharmaceutical manufacturing controls and dialysis-device compatibility requirements. The plastic container and transfer system must maintain sterility, chemical stability, container integrity, and safe connection to the patient’s peritoneal dialysis equipment.

The main regulatory risks are operational rather than clinical-development risks. They include:

• Sterility failures or microbial contamination
• Particulate or container-integrity defects
• Labeling or concentration errors
• Manufacturing-site interruptions
• Shortages of raw materials, packaging components, or sterilization capacity
• Compatibility issues with transfer sets and dialysis systems

Because DIANEAL is an established dialysis solution, the product does not have the clinical-development profile of a new molecular entity. Its regulatory value rests on continued compliance, manufacturing consistency, and supply reliability.

What patents protect DIANEAL Low Calcium With Dextrose 3.5%?

DIANEAL’s commercial protection appears to rely more on manufacturing and supply-chain barriers than on an active composition-of-matter patent estate.

A review of FDA Orange Book search materials does not identify a prominent product-specific patent blocking generic entry for the DIANEAL Low Calcium With Dextrose 3.5% plastic-container formulation. The product’s original approval dates back decades, making conventional composition-of-matter exclusivity unlikely to remain commercially relevant.[2]

Patent protection by category

Patent category	Relevance to DIANEAL
Composition of matter	Low; the formulation uses established dialysis ingredients
Dextrose concentration	Limited patent value absent a novel technical feature
Low-calcium formulation	Potentially protectable in theory, but unlikely to create long-term exclusivity for an old product
Plastic container	May be covered by packaging or container patents, but those would not necessarily block an equivalent solution in another container
Transfer system	Potential device and connector rights may affect system compatibility
Manufacturing process	Trade secrets, process controls, and facility validation are more important than broad patent rights
Method of use	Limited blocking value because peritoneal dialysis is an established therapeutic method
Orange Book patents	No prominent blocking listing identified for the specific product

The absence of a significant Orange Book patent position does not mean competitors can enter immediately. A competing manufacturer must demonstrate formulation equivalence, sterile manufacturing capability, packaging integrity, quality systems, and regulatory acceptability.

When does DIANEAL lose exclusivity?

DIANEAL’s meaningful market exclusivity has likely already expired in practical terms. The relevant commercial protection is not a remaining patent term but the difficulty of reproducing a sterile dialysis-solution supply chain at scale.

Exclusivity timeline

Milestone	Commercial significance
Original FDA approval	Established Baxter’s regulatory and manufacturing position
Patent and regulatory exclusivity period	Historically relevant, but no longer the primary barrier
Mature product phase	Competition shifts toward supply reliability, contracting, and manufacturing cost
Current market	Brand demand persists through clinical familiarity and installed dialysis infrastructure
Generic or alternative entry	Possible through abbreviated or other FDA pathways, subject to product-specific requirements

A product such as DIANEAL may remain commercially durable after formal exclusivity ends because dialysis providers prioritize continuity of supply. Switching costs include inventory redesign, staff training, protocol review, patient transition, compatibility testing, and risk management.

Are there Paragraph IV challenges to DIANEAL?

No prominent public Paragraph IV litigation is associated with DIANEAL Low Calcium With Dextrose 3.5% in the available public record. That is consistent with the product’s age, limited patent estate, and specialized market.

Paragraph IV litigation is less attractive for a mature peritoneal dialysis solution than for a high-value branded tablet or injectable with a large remaining market and multiple unexpired patents. A challenger would need to weigh:

• Limited pricing power in a concentrated dialysis market
• Manufacturing and quality-system investment
• Potentially modest standalone product revenue
• Contracting pressure from dialysis providers
• The risk of supply interruptions
• The possibility of non-patent regulatory and technical barriers

If a competitor were to file an abbreviated application, the more material dispute would likely concern formulation equivalence, product quality, manufacturing controls, container systems, or regulatory classification rather than a broad composition-of-matter patent.

What formulations are protected by DIANEAL-related intellectual property?

The commercial value of DIANEAL-related intellectual property is concentrated in the product system rather than in the active ingredients.

Formulation and delivery features

The relevant technical elements include:

• Dextrose concentration and osmotic performance
• Calcium concentration
• Electrolyte composition
• pH control
• Sterility assurance
• Container materials
• Solution stability during storage
• Transfer-set compatibility
• Manufacturing and filling processes
• Packaging and shipping conditions

A rival may be able to use the same broad ingredients while differentiating through container design, electrolyte composition, automated peritoneal dialysis compatibility, or supply configuration. Such differences can support regulatory filings or commercial differentiation even if they do not create strong patent exclusivity.

How large is the market for peritoneal dialysis solutions?

Peritoneal dialysis solutions occupy a recurring-use market linked to the global end-stage kidney disease population. Peritoneal dialysis represents a minority of dialysis treatments in many developed markets but has higher penetration in selected countries because it can be administered at home and requires less dependence on in-center infrastructure.[3]

Demand is determined by:

1. The number of peritoneal dialysis patients.
2. The frequency and volume of dialysate exchanges.
3. The mix of continuous ambulatory and automated peritoneal dialysis.
4. Conversion between hemodialysis and peritoneal dialysis.
5. Home-dialysis reimbursement.
6. Dialysis-center purchasing contracts.
7. Product availability and shortage conditions.

The market is concentrated among large renal-care suppliers. Baxter has historically been a leading supplier of peritoneal dialysis solutions and systems. Fresenius Medical Care is another major dialysis company, with a stronger overall position in hemodialysis and dialysis services but also exposure to peritoneal dialysis products and home-care programs.[4]

What was Baxter’s financial exposure to DIANEAL?

Baxter did not separately report revenue for DIANEAL Low Calcium With Dextrose 3.5%. The product was included in the company’s Kidney Care portfolio, alongside peritoneal dialysis systems, hemodialysis products, access products, and related services.

Baxter reported Kidney Care as a major operating segment before the business was sold. Public filings describe the portfolio as a large, recurring-revenue business supported by chronic renal-care demand, consumables, and equipment.[5]

Financial trajectory

Period	Financial interpretation
Mature Baxter ownership	Stable recurring demand from chronic dialysis treatment
2020-2022	Pandemic-related logistics, labor, and supply-chain pressure affected medical-product operations
2023	Kidney Care remained strategically important but exposed to cost inflation and operational complexity
2024	Baxter completed the sale of the Kidney Care business to Carlyle for approximately $3.8 billion
Post-sale	The business operates as Vantive, with DIANEAL positioned within a standalone kidney-care platform

The sale changed the financial context. Under Baxter, DIANEAL benefited from the scale of a diversified medical-products company. Under Vantive, the product sits within a narrower renal-care portfolio where dialysis consumables, home therapies, and equipment economics receive greater management focus.[6]

Product-level revenue cannot be isolated from public disclosures. The most defensible conclusion is that DIANEAL contributes recurring but undisclosed revenue within the peritoneal dialysis consumables franchise. Its financial value is higher when it supports equipment and patient-system retention than when evaluated as a standalone bag of dialysate.

Which companies compete with DIANEAL?

Competition is concentrated and regional. The principal competitive set includes:

Company	Relevant competitive position
Vantive, formerly Baxter Kidney Care	Major supplier of peritoneal dialysis solutions and systems
Fresenius Medical Care	Global dialysis provider and renal-products supplier
Regional dialysis manufacturers	Potential competitors in selected countries and procurement systems
Hospital and government procurement suppliers	May distribute branded or locally manufactured solutions

The competitive landscape is shaped by supply contracts and system compatibility. A dialysis provider may prefer a supplier capable of delivering solutions, cyclers, transfer sets, technical support, and patient training. This favors integrated vendors and raises the commercial barrier for a single-product challenger.

What generic entry risks exist for DIANEAL?

Generic entry risk is real but moderated by manufacturing economics. A competitor could seek approval for an equivalent peritoneal dialysis solution without relying on Baxter’s brand. The threat would be greatest if the entrant can offer lower pricing while matching Baxter’s quality and supply reliability.

Key entry barriers

• Sterile large-volume solution manufacturing
• High-volume filling and packaging capacity
• Validated plastic-container systems
• Quality-control testing
• Distribution to dialysis centers and home patients
• Reimbursement and formulary acceptance
• Long-term supply commitments
• Product liability exposure
• Compatibility with dialysis equipment and transfer systems

The highest commercial risk is likely price erosion in tenders rather than abrupt displacement. Dialysis providers may introduce a second supplier to obtain price concessions while retaining Baxter or Vantive as a continuity-of-supply source.

What litigation and settlement agreements affect DIANEAL?

No major publicly reported patent litigation or settlement agreement has been identified as a current market driver for DIANEAL Low Calcium With Dextrose 3.5%. The absence of litigation is consistent with the product’s mature status and limited apparent Orange Book patent exposure.

The more relevant legal risks are likely to involve:

• Product liability
• Manufacturing defects
• Regulatory enforcement
• Supply-contract disputes
• Dialysis-device compatibility
• Antitrust or procurement issues
• Healthcare reimbursement and purchasing practices

Patent settlements are less likely to determine market timing than manufacturing readiness and regulatory approval.

How does DIANEAL compare with competing peritoneal dialysis solutions?

DIANEAL competes primarily on clinical familiarity, availability, formulation range, and integration with dialysis systems.

Factor	DIANEAL	Competing solutions
Clinical familiarity	High in markets with Baxter-installed systems	Varies by geography
Dextrose options	Multiple concentrations within the portfolio	Typically comparable across major suppliers
Low-calcium option	Available in the DIANEAL range	Availability depends on supplier and country
Container system	Integrated with Baxter supply infrastructure	Competitors may use different packaging and connectors
Patent strength	Limited apparent current exclusivity	Similar mature-product profile
Switching cost	Moderate to high because of protocols and supply systems	Lower where products are technically interchangeable
Price competition	Likely at institutional tender level	Strong in markets with multiple qualified suppliers

The central competitive advantage is system-level retention. A supplier that controls the cycler, consumables, service network, and clinical support can defend a mature solution even without strong patent protection.

What is the geographic coverage of DIANEAL?

DIANEAL has been marketed internationally, but product names, concentrations, package sizes, regulatory status, and labeling can vary by country. Global commercial performance depends on:

• National dialysis reimbursement
• Home-dialysis adoption
• Local manufacturing and import requirements
• Government tenders
• Currency movements
• Regional supply-chain resilience
• Healthcare infrastructure

The United States remains strategically important because of its large dialysis population and reimbursement system. Growth opportunities are also linked to home dialysis policy and patient adoption. Emerging markets may offer volume growth but often have greater price pressure and procurement dependence.

How strong is the patent estate for DIANEAL?

The patent estate is weak as a standalone exclusivity instrument but the broader commercial moat is moderate.

Patent-strength assessment

Dimension	Assessment
Remaining composition patent	Low
Method-of-use protection	Low
Orange Book blocking position	Limited
Manufacturing know-how	Moderate to high
Regulatory and quality barriers	High
Distribution and contracting	High
Brand and clinical familiarity	Moderate
System integration	Moderate to high
Litigation leverage	Low

The product’s value is therefore defensive rather than patent-driven. A new entrant can potentially avoid Baxter’s historical patents but still face a difficult commercialization process.

What is the outlook for DIANEAL revenue?

DIANEAL revenue is likely to remain stable to modestly growing in nominal terms if the peritoneal dialysis patient base expands and supply reliability remains strong. Volume growth can be offset by:

• Price reductions in competitive tenders
• Generic or private-label entry
• Conversion to hemodialysis
• Reimbursement pressure
• Manufacturing disruptions
• Lower use of higher-dextrose solutions where clinicians seek to reduce glucose exposure

The post-Baxter ownership structure may increase focus on renal-care portfolio economics. Vantive can use DIANEAL to support a broader home-dialysis strategy, but the company also faces concentrated-customer risk and the need to fund manufacturing and quality infrastructure.

Key Takeaways

• DIANEAL Low Calcium With Dextrose 3.5% is a mature peritoneal dialysis solution supplied in a plastic container by Baxter’s former Kidney Care business, now Vantive.
• Product-level revenue is not publicly disclosed.
• The product’s commercial value is tied to recurring dialysate consumption and system retention, not new-drug pricing.
• No prominent current Orange Book patent barrier or Paragraph IV litigation driver is associated with the product.
• Manufacturing validation, sterility, container integrity, supply reliability, and dialysis-system compatibility are more important than remaining patent exclusivity.
• Generic entry would likely create tender-level price pressure rather than an immediate market collapse.
• Baxter completed the sale of its Kidney Care business to Carlyle for approximately $3.8 billion in 2024, changing the product’s ownership and financial reporting context.
• The principal competitors are Vantive, Fresenius Medical Care, and regional dialysis-solution suppliers.
• The long-term outlook is stable, with growth dependent on peritoneal dialysis adoption, home-care reimbursement, and reliable supply.

FAQs

Is DIANEAL Low Calcium 3.5% a generic drug?

No. DIANEAL is a branded peritoneal dialysis solution. However, it is a mature product with established ingredients and limited apparent current patent exclusivity, so equivalent competing solutions may be possible.

Does DIANEAL have an active composition-of-matter patent?

No prominent active composition-of-matter patent is associated with the mature DIANEAL Low Calcium 3.5% product in current public patent and Orange Book materials.

Is DIANEAL used in automated peritoneal dialysis?

DIANEAL solutions can be used in peritoneal dialysis regimens, including automated peritoneal dialysis, when prescribed and administered with compatible equipment and appropriate clinical protocols.

Who owns the business that formerly marketed DIANEAL through Baxter?

Carlyle acquired Baxter’s Kidney Care business in 2024. The business was rebranded Vantive and includes the former Baxter renal-care portfolio.

Can a competitor launch a lower-priced DIANEAL alternative?

Potentially. The main barriers are FDA regulatory compliance, sterile large-volume manufacturing, packaging validation, dialysis-system compatibility, customer contracts, and dependable distribution. Patent clearance alone would not ensure successful entry.

References

1. U.S. Food and Drug Administration. (n.d.). DIANEAL peritoneal dialysis solution prescribing information. Baxter Healthcare Corporation.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.

3. United States Renal Data System. (2023). 2023 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health.

4. Fresenius Medical Care AG. (2023). Annual report 2023. Fresenius Medical Care.

5. Baxter International Inc. (2023). Annual report 2023. Baxter International Inc.

6. Baxter International Inc. (2024, August 30). Baxter completes sale of Kidney Care business to Carlyle. Baxter International Inc.