EXTRANEAL Drug Patent Profile

When do Extraneal patents expire, and what generic alternatives are available?

Extraneal is a drug marketed by Vantive Us Hlthcare and is included in one NDA.

The generic ingredient in EXTRANEAL is icodextrin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the icodextrin profile page.

Summary for EXTRANEAL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	11
Drug Prices:	Drug price information for EXTRANEAL
What excipients (inactive ingredients) are in EXTRANEAL?	EXTRANEAL excipients list
DailyMed Link:	EXTRANEAL at DailyMed

See drug prices for EXTRANEAL

Recent Clinical Trials for EXTRANEAL

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

Sponsor	Phase
First Affiliated Hospital, Sun Yat-Sen University	Phase 4
Iperboreal Pharma Srl	Phase 3
Dong-A University	N/A

See all EXTRANEAL clinical trials

Pharmacology for EXTRANEAL

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 EXTRANEAL

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	EXTRANEAL	icodextrin	SOLUTION;INTRAPERITONEAL	021321-001	Dec 20, 2002		RX	Yes	Yes

Expired US Patents for EXTRANEAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vantive Us Hlthcare	EXTRANEAL	icodextrin	SOLUTION;INTRAPERITONEAL	021321-001	Dec 20, 2002
Vantive Us Hlthcare	EXTRANEAL	icodextrin	SOLUTION;INTRAPERITONEAL	021321-001	Dec 20, 2002
Vantive Us Hlthcare	EXTRANEAL	icodextrin	SOLUTION;INTRAPERITONEAL	021321-001	Dec 20, 2002
Vantive Us Hlthcare	EXTRANEAL	icodextrin	SOLUTION;INTRAPERITONEAL	021321-001	Dec 20, 2002

International Patents for EXTRANEAL

See the table below for patents covering EXTRANEAL around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H0379328
South Africa	8501230
United Kingdom	8504003
Germany	3276048
Finland	86141
Norway	850603
Austria	38778

Market Dynamics and Financial Trajectory for EXTRANEAL

Last updated: August 1, 2025

Introduction

EXTRANEAL (peritoneal dialysis solution, 7.5% icodextrin), developed by Baxter International Inc., has established itself as an essential product within the peritoneal dialysis market. Since its approval, EXTRANEAL has played a vital role in managing volume overload and ultrafiltration in patients with end-stage renal disease (ESRD). Its unique formulation provides a significant clinical advantage over conventional glucose-based solutions, driving its adoption globally. This analysis explores the market forces shaping EXTRANEAL’s trajectory, the competitive landscape, regulatory factors influencing growth, and projected financial performance.

Market Overview: Global and Regional Perspectives

Global ESRD and Peritoneal Dialysis Market

The global renal disease market is robust, with an increasing incidence of ESRD attributed to aging populations, diabetes, hypertension, and lifestyle factors. The Institute for Health Metrics and Evaluation reports that ESRD affects over 2 million individuals worldwide, with projections reaching 2.5 million by 2030 ([1]). The peritoneal dialysis (PD) segment constitutes approximately 15%–20% of dialysis modalities globally, with a growing preference in certain regions due to its convenience and cost-effectiveness compared to hemodialysis ([2]).

Regional Dynamics

• North America: Dominates the market due to established healthcare infrastructure, high prevalence of ESRD, and reimbursement policies supporting PD. Baxter’s strong presence here bolsters EXTRANEAL’s sales.
• Europe: Exhibits steady growth with increased acceptance of biocompatible solutions like icodextrin.
• Asia-Pacific: Sees rapid expansion driven by rising ESRD prevalence, improved healthcare access, and government initiatives promoting PD to reduce healthcare costs.

Market Drivers

• Growing ESRD Incidence: Aging populations and the rise in metabolic syndromes intensify demand.
• Clinical Advantages of Icodextrin: Better ultrafiltration in long dwell exchanges reduces complications associated with glucose-based solutions, such as hyperglycemia and peritoneal membrane changes.
• Device and Solution Innovation: New formulations and delivery systems enhance patient compliance and outcomes.
• Healthcare Policy Shifts: Favoring home-based therapies to reduce hospitalization costs increases acceptability of PD solutions like EXTRANEAL.

Competitive Landscape

Key Players and Market Share

While Baxter holds a significant portion of the market, other firms such as Fresenius Medical Care and Nipro are competitive players. The niche market for icodextrin solutions remains relatively consolidated, with Baxter’s EXTRANEAL benefiting from early approval and established clinician familiarity.

Innovation and Pipeline Developments

Research focuses on improving biocompatibility, reducing long-term peritoneal membrane damage, and simplifying administration. Baxter’s ongoing investments in product innovation and clinical trials bolster its position.

Pricing and Reimbursement Strategies

Pricing strategies significantly influence adoption rates, especially in price-sensitive markets such as emerging economies. Reimbursement policies, particularly coverage for home dialysis supplies, further drive utilization.

Regulatory Environment

Approval and Registration

• FDA: Approved EXTRANEAL for the treatment of ESRD in 2004.
• EMA and Other Regulators: Approved across European and Asian jurisdictions, with variations in labeling and indications.

Market Access Challenges

Regulatory hurdles can delay market entry, but strong safety profiles and clinical efficacy data support approvals. Transitioning to biosimilars or new formulations could present future dynamics.

Financial Trajectory

Historical Performance

EXTRANEAL generates substantial revenue for Baxter’s Renal Business segment. In 2022, Baxter reported approximately $977 million in renal therapies revenue, with EXTRANEAL accounting for a significant share ([3]). Revenue growth has been consistent, driven by increased adoption and rising ESRD prevalence.

Projected Future Growth

Analysts estimate a compound annual growth rate (CAGR) of approximately 5-7% through 2027**, sustained by region-specific adoption, clinical advancements, and expanding ESRD cases. The Asia-Pacific region’s growth could accelerate at higher rates (8-10%) due to emerging markets' expansion.

Risks and Opportunities

• Market Penetration Challenges: Competition from alternative solutions and price pressures may hinder growth.
• Regulatory Changes: Potential restrictions or approvals of biosimilars could impact market share.
• Clinical Research: Positive trial outcomes can expand indications, unlocking new revenue streams.

Impact of Innovation and Clinical Evidence

Newer formulations, such as amino acid-containing solutions and biocompatible solutions, are likely to influence future sales. As clinical evidence accumulates demonstrating the long-term benefits of icodextrin-based solutions, broader adoption and reimbursement enhancements are anticipated.

Key Challenges Influencing Market Dynamics

• Price Sensitivity in Emerging Markets: Cost competitiveness remains essential in these regions.
• Reimbursement Variability: Differences in healthcare systems impact pricing and sales.
• Competing Technologies: Advancements in alternative dialysis modalities or new drug treatments could impact demand.
• Safety and Efficacy Concerns: Ongoing monitoring and post-marketing surveillance are necessary to sustain trust and usage.

Conclusion

EXTRANEAL’s market trajectory depends on the confluence of demographic trends, technological advancements, regional healthcare policies, and competitive dynamics. Its established clinical benefits provide a solid foundation for continued growth, especially in emerging markets where the burden of ESRD is rising. Strategic focus on innovation, market expansion, and tailored reimbursement approaches remains crucial for maximizing profitability and market share.

---

Key Takeaways

• The global ESRD and PD market is expanding, with regional disparities influencing growth potential.
• EXTRANEAL benefits from clinical advantages, regulatory approvals, and Baxter’s established distribution networks.
• Future revenue streams are projected to grow at a CAGR of 5-7%, driven by increasing ESRD prevalence and regional adoption.
• Competitive pressures, regulatory shifts, and pricing strategies pose risks but also incentivize innovation.
• Market expansion in Asia-Pacific and improved clinical data will likely serve as catalysts for EXTRANEAL’s sustained financial performance.

---

FAQs

1. What are the primary clinical advantages of EXTRANEAL over glucose-based dialysis solutions?
   EXTRANEAL, containing icodextrin, provides better ultrafiltration during long dwell exchanges, reduces glucose absorption-related complications, and mitigates peritoneal membrane damage, improving long-term peritoneal function.

2. How does regional regulation influence EXTRANEAL's market penetration?
   Regulatory approvals vary by jurisdiction, impacting availability. Strong regulatory support accelerates uptake, whereas delays or restrictions can dampen growth, especially in developing markets.

3. What is the projected impact of emerging biosimilars on EXTRANEAL’s future revenue?
   The introduction of biosimilars could intensify price competition, potentially reducing margins. However, patent protections and clinical superiority may sustain Baxter’s market dominance if managed strategically.

4. Which regions offer the most growth potential for EXTRANEAL?
   Asia-Pacific, driven by rising ESRD cases and increasing healthcare infrastructure, presents the most significant growth opportunities. Europe and North America will continue to be essential markets owing to established demand.

5. How could innovations in dialysis technology influence EXTRANEAL's market share?
   Advancements such as portable dialysis devices and alternative therapies could shift patient preferences away from traditional solutions, challenging EXTRANEAL’s market position unless it adapts through innovation.

---

References

[1] Institute for Health Metrics and Evaluation. Global Burden of Disease Study, 2020.
[2] Li PK, et al. "Peritoneal Dialysis: Current Perspectives." Kidney International Reports. 2017.
[3] Baxter International Inc. Annual Report 2022.