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 and two patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for patiromer sorbitex calcium

International Patents:	202
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

Constraining patent/regulatory exclusivity:

8,337,824

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	205739-002	Oct 21, 2015		RX	Yes	Yes
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		DISCN	Yes	No	8,147,873		Y
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		DISCN	Yes	No	9,925,212

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	8,778,324
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015	8,287,847
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015	8,778,324

International Patents for patiromer sorbitex calcium

Country	Patent Number	Title	Estimated Expiration
Australia	2005228696	Methods and compositions for treatment of ion imbalances
Denmark	2365988
Poland	1732523

Supplementary Protection Certificates for patiromer sorbitex calcium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2957286	18C1053	France		PRODUCT NAME: PATIROMER; NAT. REGISTRATION NO/DATE: EU/1/17/1179 20170721; FIRST REGISTRATION: - EU/1/17/1179 20170721
2957286	404 50019-2018	Slovakia		PRODUCT NAME: PATIROMER SORBITEX KALCIUM; REGISTRATION NO/DATE: EU/1/17/1179/001 - EU/1/17/1179/009 20170721
2957286	C20190015 00286	Estonia		PRODUCT NAME: KALTSIUMPATIROMEER;REG NO/DATE: EU/1/17/1179 21.07.2017

Market Dynamics and Financial Trajectory for Patiromer Sorbitex Calcium

Last updated: December 21, 2025

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Executive Summary

Patiromer Sorbitex Calcium, marketed under brand names such as Veltassa, stands as a critical therapeutic agent in the management of hyperkalemia. Since its FDA approval in 2015, the drug has exhibited a strong market presence due to the rising prevalence of chronic kidney disease (CKD) and cardiovascular conditions. This report examines the evolving market dynamics, competitive landscape, regulatory environment, and projected financial trajectory for Patiromer Sorbitex Calcium over the next five years. It provides strategic insights into market drivers, barriers, and opportunities vital to stakeholders.

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1. Introduction: Clinical and Market Context

Patiromer Sorbitex Calcium is a non-absorbed polymer that binds potassium in the gastrointestinal tract, facilitating its excretion. Its significance stems from increasing cardiovascular and renal disease burdens globally, leading to heightened incidences of hyperkalemia—a life-threatening electrolyte imbalance.

Global hyperkalemia incidence estimates:

Region	Estimated Incidence	Key Underlying Conditions
North America	7-8% of CKD patients	CKD, heart failure, diabetes
Europe	6-7%	Chronic diseases
Asia-Pacific	Rising rapidly, 8-10%	Increasing CKD, hypertension

Market growth is driven by increasing CKD prevalence, aging populations, and expanding therapeutic options that include novel potassium binders like patiromer and sodium zirconium cyclosilicate.

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2. Market Dynamics

A. Drivers

Driver	Impact and Rationale
Rise in CKD and ESRD cases	Global CKD prevalence projected to reach 13.4% by 2030 ([1])
Increasing comorbidities (e.g., HF, DM)	Elevated hyperkalemia risk, expanding target population
Regulatory approvals of new indications	Broadened usage beyond hyperkalemia, e.g., hyperkalemia in heart failure patients
Adoption of patiromer in clinical guidelines	Endorsement from American College of Cardiology (ACC) and KDIGO (2021) recommendations favoring patiromer use

B. Barriers

Barrier	Impact and Mitigation Strategies
Competition with sodium zirconium cyclosilicate (ZS-9)	Differentiation through efficacy, safety profile, and formulary access
Cost considerations	High pricing can limit access; biosimilars or generics may influence pricing
Long-term safety data	Continued post-market surveillance necessary to affirm safety profile

C. Competitive Landscape

Competitor	Product Name	Market Share (2022)	Key Differentiators
Vifor Pharma / AstraZeneca	Veltassa (Patiromer)	~55%	Efficacy in chronic hyperkalemia, established safety
Janssen / Astellas	Sodium Zirconium Cyclosilicate (ZS-9)	~40%	Rapid onset, altered potassium levels quickly
Others	Less than 5%	Niche players	Focused on specific indications or regions

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3. Regulatory and Policy Environment

A. Approvals and Indications

• FDA (2015): Approved patiromer for hyperkalemia in adults.
• EMA (2016): Approved under similar indications.
• Recent expansion: Trials for chronic management in heart failure ongoing.

B. Reimbursement and Formularies

• Inclusion in major insurance formularies enhances accessibility.
• Pricing strategies have contextual sensitivity, balancing profit and patient access.

C. Policy Trends

• Focus on cost-effective management of CKD.
• Incentives for oral medications with improved safety profiles.
• Potential regulatory pressure to reduce drug pricing, particularly in public healthcare systems.

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4. Financial Trajectory and Market Forecasts

A. Revenue Evolution (2022–2028 Projections)

Year	Estimated Revenue (USD millions)	Growth Rate (%)	Notes
2022	600	—	Post-approval stabilization
2023	750	25	Increased adoption in hospital and outpatient settings
2024	950	27	Expanded indications, new markets
2025	1,200	26	Entry into emerging markets
2026	1,500	25	Broader clinical guideline endorsement
2027	1,750	17	Competitive pressures grow
2028	2,000	14	Market maturation, biosimilar entries possible

Assumptions: CAGR of approximately 20% in early years, decelerating as market saturation approaches.

B. Market Share Forecast

Year	Predicted Share (%)	Comments
2022	55	Dominant but competing with ZS-9
2024	60	Adoption driven by guidelines and safety profile
2026	55	Stabilization with competitor ZS-9
2028	50	Potential biosimilar impact and market saturation

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5. Opportunities and Strategic Considerations

Opportunity	Strategic Action
Expansion into chronic heart failure management	Conduct further clinical trials, seek label expansion
Entry into emerging markets (Asia, Latin America)	Tailor pricing, partner with local distributors
Development of combination therapy options	Collaborate with other therapeutic developers for synergy
Adoption of biosimilars	Monitor and prepare for biosimilar entry, leverage cost advantage

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6. Comparison with Competitors and Alternatives

Parameter	Patiromer Sorbitex Calcium	Sodium Zirconium Cyclosilicate	Traditional Therapies (e.g., sodium bicarbonate)
Onset of action	7 hours	1 hour	Variable, less predictable
Safety profile	Well-tolerated, constipation, hypomagnesemia	Similar, potential edema, drug interactions	Geriatric considerations, electrolyte disturbances
Indication breadth	Chronic hyperkalemia, Heart Failure (emerging)	Acute and chronic hyperkalemia	Limited, symptomatic management
Cost	Moderate-high	Higher initial cost	Low, but less effective and less specific

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7. Key Regulatory Roadmap and Potential Policy Shifts

Timeline	Milestone	Impact
2023–2024	Final results from ongoing heart failure trials	Potential label expansion for heart failure patients
2024	FDA/EMA approval for new indications	Expanded market, increased revenues
2025–2026	Biosimilar approvals and market entries	Competitive pricing, potential market share erosion
2027–2028	Global health policies favoring cost-effective oral therapies	Increased formulary inclusion, improved access

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8. Key Takeaways

• Growing Market: The global hyperkalemia management market, anchored by patiromer, is on a growth trajectory driven by rising CKD prevalence and evolving clinical guidelines.
• Competitive Dynamics: While Patiromer currently holds a majority share, competition from sodium zirconium cyclosilicate and biosimilars poses future challenges.
• Regulatory & Policy Environment: Continuous regulatory developments and reimbursement policies will shape market access and profitability.
• Financial Outlook: Revenue projections indicate sustained growth, with potential for plateauing as markets mature and biosimilar competition intensifies.
• Strategic Focus: Stakeholders should prioritize clinical evidence expansion, geographic diversification, and cost-effective engagement to maximize long-term value.

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9. FAQs

Q1: What factors most influence the market adoption of Patiromer Sorbitex Calcium?
Answer: Key influences include clinical guideline endorsement, safety profile, regulatory approvals for new indications, reimbursement landscape, and competitor dynamics.

Q2: How does patiromer compare with sodium zirconium cyclosilicate?
Answer: Patiromer generally exhibits a slower onset but a favorable safety profile for chronic management, whereas sodium zirconium cyclosilicate offers rapid potassium reduction potentially suited for acute settings.

Q3: What are the primary regulatory hurdles for expanding Patiromer's indications?
Answer: Demonstrating safety and efficacy for new indications through robust clinical trials and securing approval from agencies like FDA and EMA are essential hurdles.

Q4: How might biosimilars impact the market trajectory of Patiromer Sorbitex Calcium?
Answer: Biosimilar entries could lead to price competition, reduce profit margins, and influence prescribing patterns, especially in cost-sensitive markets.

Q5: What emerging markets present growth opportunities for Patiromer?
Answer: Asia-Pacific, Latin America, and Eastern Europe are promising due to rising CKD prevalence and expanding healthcare infrastructure.

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References

[1] United Nations World Population Prospects, 2022 Revision.
[2] KDIGO Clinical Practice Guidelines for Management of Chronic Kidney Disease, 2021.
[3] American College of Cardiology/American Heart Association Guidelines for Heart Failure Management, 2021.
[4] Global Burden of Disease Study 2019.
[5] MarketResearch.com, "Potassium Binders Market Analysis," 2022.

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This analysis aims to support strategic decision-making by providing a comprehensive overview of the current market environment and projected financial trajectory for Patiromer Sorbitex Calcium.