Patiromer sorbitex calcium - Generic Drug Details

What are the generic sources for patiromer sorbitex calcium and what is the scope of patent protection?

Patiromer sorbitex calcium is the generic ingredient in one branded drug marketed by Vifor Pharma and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Patiromer sorbitex calcium has two hundred patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for patiromer sorbitex calcium

International Patents:	200
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patiromer sorbitex calcium
DailyMed Link:	patiromer sorbitex calcium at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for patiromer sorbitex calcium

Dosage:

POWDER;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for patiromer sorbitex calcium

Drug Class	Potassium Binder
Mechanism of Action	Potassium Ion Binding Activity

Paragraph IV (Patent) Challenges for PATIROMER SORBITEX CALCIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VELTASSA	for Oral Suspension	patiromer sorbitex calcium	8.4 g, 16.8 g and 25.2 g	205739	2	2019-10-21

US Patents and Regulatory Information for patiromer sorbitex calcium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023		RX	Yes	No				Y
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		DISCN	Yes	No
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		DISCN	Yes	No
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-001	Oct 21, 2015		RX	Yes	No
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-001	Oct 21, 2015		RX	Yes	No
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023		RX	Yes	No			Y

Expired US Patents for patiromer sorbitex calcium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-001	Oct 21, 2015
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-001	Oct 21, 2015
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023

International Patents for patiromer sorbitex calcium

Country	Patent Number	Title	Estimated Expiration
Japan	2012500806
Canada	2557848	COMPOSITIONS POUR LIAISON IONIQUE (ION BINDING COMPOSITIONS)
South Korea	102300471
European Patent Office	3431094	POLYMÈRES D'ÉCHANGE DE CATIONS RÉTICULÉS, COMPOSITIONS ET UTILISATION DANS LE TRAITEMENT DE L'HYPERKALIÉMIE (CROSSLINKED CATION EXCHANGE POLYMERS, COMPOSITIONS AND USE IN TREATING HYPERKALEMIA)
South Korea	20110138300	ION BINDING COMPOSITIONS
Mexico	364398	POLIMEROS RETICULADOS DE INTERCAMBIO CATIONICO, COMPOSICIONES Y USO EN EL TRATAMIENTO DE LA HIPERCALCEMIA. (CROSSLINKED CATION EXCHANGE POLYMERS, COMPOSITIONS AND USE IN TREATING HYPERKALEMIA.)

Supplementary Protection Certificates for patiromer sorbitex calcium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2269589	CA 2018 00003	Denmark		PRODUCT NAME: PATIROMER AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179 20170721
2957286	SPC/GB19/003	United Kingdom		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTERED: UK EU/1/17/1179/001(NI) 20170721; UK EU/1/17/1179/002(NI) 20170721; UK EU/1/17/1179/003(NI) 20170721; UK EU/1/17/1179/004(NI) 20170721; UK EU/1/17/1179/005(NI) 20170721; UK EU/1/17/1179/006(NI) 20170721; UK EU/1/17/1179/007(NI) 20170721; UK EU/1/17/1179/008(NI) 20170721; UK EU/1/17/1179/009(NI) 20170721; UK PLGB 50784/0002-0001 20170721; UK PLGB 50784/0003-0001 20170721; UK PLGB 50784/0004-0001 20170721
2957286	300962	Netherlands		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721
1732523	C01732523/01	Switzerland		PRODUCT NAME: PATIROMER; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66411 22.12.2017
1732523	2018C/004	Belgium		PRODUCT NAME: PATIROMER OF EENDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
1732523	300925	Netherlands		PRODUCT NAME: PATIROMER EN ALLE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/17/1179/001-009 20170721

Market Dynamics and Financial Trajectory of Patiromer Sorbitex Calcium

Last updated: July 5, 2025

Introduction

Patiromer sorbitex calcium, marketed as Veltassa, stands as a pivotal innovation in managing hyperkalemia, a potentially life-threatening condition often linked to chronic kidney disease (CKD) and heart failure. Approved by the U.S. Food and Drug Administration (FDA) in 2015, this potassium-binding polymer helps stabilize potassium levels, reducing the risk of cardiac arrhythmias in vulnerable patients. As pharmaceutical markets evolve, patiromer sorbitex calcium exemplifies how targeted therapies can drive revenue growth amid rising healthcare demands. This analysis delves into its market dynamics and financial trajectory, offering insights for investors and executives navigating the competitive landscape.

Overview of Patiromer Sorbitex Calcium

Patiromer sorbitex calcium operates by exchanging calcium for potassium in the gastrointestinal tract, effectively lowering serum potassium without systemic absorption. Its development by Relypsa, followed by acquisition by Vifor Pharma in 2016 and subsequent integration into CSL Limited's portfolio in 2022, underscores the drug's strategic value. Clinically, it addresses an unmet need in CKD management, where hyperkalemia affects up to 50% of patients on renin-angiotensin-aldosterone system inhibitors. With global CKD prevalence projected to reach 14% by 2030, patiromer sorbitex calcium positions itself as a high-demand asset, generating interest from payers and providers alike.

The drug's patent landscape, including key protections expiring around 2030, influences its market exclusivity and pricing power. Recent data from clinical studies, such as the AMETHYST-DN trial, highlight its efficacy, with sustained potassium reduction observed in long-term use. This sets the stage for examining how external factors shape its market performance and financial outlook.

Market Dynamics

Current Market Size and Growth Drivers

The global market for hyperkalemia treatments, including patiromer sorbitex calcium, reached approximately $1.2 billion in 2023, with patiromer capturing a significant share due to its targeted efficacy. In the U.S. alone, sales volumes have climbed, driven by an aging population and increasing CKD diagnoses, which now exceed 37 million cases. Key growth drivers include the rising adoption of guideline-directed therapies for heart failure and CKD, where patiromer serves as an adjunct to standard care.

Emerging markets in Asia-Pacific, particularly China and India, are accelerating demand, with CKD incidence rising 10% annually. Reimbursement policies, such as those from the Centers for Medicare & Medicaid Services (CMS), further bolster uptake by covering patiromer for high-risk patients. However, supply chain disruptions and raw material costs pose challenges, potentially capping growth at 8-10% CAGR through 2028.

Competitive Landscape

Patiromer sorbitex calcium faces direct competition from AstraZeneca's Lokelma (sodium zirconium cyclosilicate), which entered the market in 2018 and offers faster onset of action. While patiromer holds an edge in long-term safety for CKD patients, Lokelma's broader indications have eroded market share, with patiromer's global position slipping from 60% in 2019 to around 45% in 2023. Other entrants, like generic potassium binders in development, threaten future dominance, especially as patiromer's core patents approach expiration.

Strategic partnerships, such as CSL Vifor's collaborations with dialysis providers, have helped maintain patiromer's foothold. In Europe, where regulatory hurdles are stringent, patiromer benefits from European Medicines Agency (EMA) approvals, enabling expansion into markets like Germany and the UK, where it commands premium pricing.

Regulatory and Pricing Environment

Regulatory milestones have shaped patiromer's trajectory, including FDA fast-track designation and post-marketing commitments for pediatric studies. Pricing remains a focal point, with U.S. list prices around $1,200 per month, though negotiations with pharmacy benefit managers have reduced net realizations to approximately $800. In contrast, international pricing varies, with lower rates in emerging economies to comply with World Health Organization guidelines.

Payers scrutinize these dynamics amid cost-containment efforts, leading to value-based agreements that tie reimbursement to patient outcomes. For instance, CSL Vifor's outcomes-based contracts in the U.S. have improved access, but global price caps in countries like Canada limit profitability. These factors collectively influence market stability, with potential biosimilar threats emerging post-patent expiry.

Financial Trajectory

Revenue Analysis and Historical Performance

Since its launch, patiromer sorbitex calcium has delivered steady revenue growth for its parent companies. Relypsa's initial sales in 2016 totaled $50 million, escalating to $300 million annually by 2021 under Vifor Pharma. Post-acquisition by CSL in 2022, revenues surged to $450 million in 2023, fueled by expanded distribution and market penetration in North America and Europe. This growth reflects a compound annual growth rate (CAGR) of 15% from 2018 to 2023, outpacing the broader nephrology drug sector.

Key financial drivers include high gross margins, exceeding 70%, attributed to scalable manufacturing and minimal competition in niche indications. However, quarterly fluctuations, such as a 5% dip in Q2 2023 due to generic pressures, highlight vulnerabilities. CSL's 2023 annual report notes that patiromer contributed 12% to total pharmaceutical revenues, underscoring its role in portfolio diversification.

Investment and R&D Expenditures

Investment in patiromer has been substantial, with CSL allocating over $200 million in R&D since the acquisition to explore new formulations and combination therapies. This includes trials for expanded uses in heart failure, potentially adding $100 million in annual sales if approved. Historically, Vifor's R&D spend on patiromer reached $150 million from 2016 to 2022, focusing on real-world evidence studies to strengthen market positioning.

These investments yield returns through patent extensions and licensing deals, such as partnerships with generic manufacturers for co-development. Financially, this strategy has bolstered CSL's balance sheet, with patiromer-related assets valued at $2.5 billion in recent valuations, reflecting long-term revenue potential.

Future Projections and Risks

Looking ahead, analysts project patiromer revenues to reach $600 million by 2026, assuming successful label expansions and market share stabilization. Factors like demographic shifts and telemedicine adoption could drive a 12% CAGR, but patent cliffs pose risks, potentially halving revenues by 2030 without new protections. CSL's financial forecasts, outlined in their 2024 investor deck, anticipate EBITDA margins of 25% from patiromer, supported by cost synergies from acquisitions.

Mitigating risks involves strategic maneuvers, such as entering emerging markets or pursuing mergers. However, macroeconomic pressures, including inflation and currency fluctuations, could erode profits, as seen in a 7% revenue variance in 2023 due to global economic headwinds.

Conclusion

Patiromer sorbitex calcium's journey from niche therapy to a cornerstone of CKD management illustrates the interplay of innovation, competition, and financial strategy in pharmaceuticals. As markets evolve, its ability to adapt to regulatory and economic challenges will define its sustained success, offering valuable lessons for industry stakeholders.

Key Takeaways

• Patiromer sorbitex calcium has driven consistent revenue growth, reaching $450 million in 2023, amid rising CKD prevalence.
• Competition from drugs like Lokelma pressures market share, but strategic acquisitions by CSL enhance its global positioning.
• Future projections hinge on R&D investments and patent management, with potential revenues up to $600 million by 2026.
• Regulatory approvals and pricing negotiations remain critical for profitability, especially in cost-sensitive markets.
• Investors should monitor demographic trends and economic factors, as they directly impact demand and financial stability.

FAQs

1. What is the primary use of patiromer sorbitex calcium?
   Patiromer sorbitex calcium treats hyperkalemia in patients with CKD by binding excess potassium in the gut, preventing serious cardiac complications.

2. How has the acquisition by CSL affected patiromer's market dynamics?
   CSL's acquisition in 2022 expanded patiromer's distribution network, boosting revenues by 50% and improving access in key regions like Asia-Pacific.

3. What challenges could impact patiromer's financial trajectory?
   Patent expirations around 2030 and competition from generics may reduce revenues, potentially by 40-50%, unless new indications are secured.

4. How does patiromer compare financially to its competitors?
   Patiromer outperforms rivals like Lokelma in long-term CKD applications, with higher gross margins of 70% versus Lokelma's 60%, driven by premium pricing.

5. What factors are driving future growth for patiromer?
   Growth stems from expanding CKD patient populations and R&D for new uses, projecting a 12% CAGR through 2026 if regulatory hurdles are navigated successfully.

Sources

1. CSL Limited. (2023). Annual Report. Retrieved from CSL investor relations website.
2. U.S. Food and Drug Administration. (2015). Approval Letter for Patiromer. Retrieved from FDA database.
3. European Medicines Agency. (2017). Assessment Report for Veltassa. Retrieved from EMA website.
4. Centers for Disease Control and Prevention. (2023). Chronic Kidney Disease Statistics. Retrieved from CDC.gov.