SODIUM ZIRCONIUM CYCLOSILICATE - Generic Drug Details

What are the generic drug sources for sodium zirconium cyclosilicate and what is the scope of freedom to operate?

Sodium zirconium cyclosilicate is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sodium zirconium cyclosilicate has one hundred and thirty-one patent family members in thirty-eight countries.

Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for SODIUM ZIRCONIUM CYCLOSILICATE

International Patents:	131
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	33
Patent Applications:	45
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SODIUM ZIRCONIUM CYCLOSILICATE
What excipients (inactive ingredients) are in SODIUM ZIRCONIUM CYCLOSILICATE?	SODIUM ZIRCONIUM CYCLOSILICATE excipients list
DailyMed Link:	SODIUM ZIRCONIUM CYCLOSILICATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SODIUM ZIRCONIUM CYCLOSILICATE

Constraining patent/regulatory exclusivity:

9,592,253

Dosage:

FOR SUSPENSION;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.

Recent Clinical Trials for SODIUM ZIRCONIUM CYCLOSILICATE

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

Sponsor	Phase
Mario Negri Institute for Pharmacological Research	PHASE3
Qianfoshan Hospital	PHASE4
Fundación para la Investigación del Hospital Clínico de Valencia	PHASE3

See all SODIUM ZIRCONIUM CYCLOSILICATE clinical trials

Generic filers with tentative approvals for SODIUM ZIRCONIUM CYCLOSILICATE

Applicant	Application No.	Strength	Dosage Form
		10G	POWDER, FOR SUSPENSION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for SODIUM ZIRCONIUM CYCLOSILICATE

V03AE	Drugs for treatment of hyperkalemia and hyperphosphatemia
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for SODIUM ZIRCONIUM CYCLOSILICATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LOKELMA	for Oral Suspension	sodium zirconium cyclosilicate	5 g/packet and 10 g/packet	207078	5	2022-05-18

US Patents and Regulatory Information for SODIUM ZIRCONIUM CYCLOSILICATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No	9,861,658
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018		RX	Yes	Yes	10,413,569			Y
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No	9,844,567
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No	8,808,750
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018		RX	Yes	Yes	8,802,152			Y

Expired US Patents for SODIUM ZIRCONIUM CYCLOSILICATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018	6,332,985
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018	6,332,985

EU/EMA Drug Approvals for SODIUM ZIRCONIUM CYCLOSILICATE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AstraZeneca AB	Lokelma	sodium zirconium cyclosilicate	EMEA/H/C/004029Lokelma is indicated for the treatment of hyperkalaemia in adult patients.	Authorised	no	no	no	2018-03-22

International Patents for SODIUM ZIRCONIUM CYCLOSILICATE

Country	Patent Number	Title	Estimated Expiration
Philippines	12018500786	EXTENDED USE ZIRCONIUM COMPOSITIONS AND METHODS OF USE THEREOF
Lithuania	PA2019010
Brazil	112018007189	composições de silicato de zircônio para uso prolongado e métodos de uso dos mesmos
Denmark	2673237
World Intellectual Property Organization (WIPO)	2012109590

Supplementary Protection Certificates for SODIUM ZIRCONIUM CYCLOSILICATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2673237	C201930028	Spain		PRODUCT NAME: CICLOSILICATO DE SODIO Y ZIRCONIO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1173; DATE OF AUTHORISATION: 20180322; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1173; DATE OF FIRST AUTHORISATION IN EEA: 20180322
0290047	SPC/GB97/078	United Kingdom		PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522
0579826	02C0041	France		PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
2822954	18C1035	France		PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
3347352	SPC/GB22/064	United Kingdom		PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; REGISTERED: UK EU/1/22/1671(FOR NI) 20220819; UK MORE ON HISTORY TAB 20220819

Market Dynamics and Financial Trajectory for Sodium Zirconium Cyclosilicate

Last updated: July 29, 2025

Introduction

Sodium zirconium cyclosilicate (SZC), marketed under the brand name Lokelma among others, is a novel pharmaceutical formulated to treat hyperkalemia—a condition characterized by elevated serum potassium levels that pose significant health risks. Since its FDA approval in 2018, SZC has been positioned as a targeted, non-absorbed potassium binder. This article delineates the evolving market dynamics and financial trajectory for SZC, analyzing factors influencing demand, competition, regulatory environment, and commercial prospects.

Market Overview

The global hyperkalemia market has experienced notable growth owing to increasing prevalence of chronic kidney disease (CKD), heart failure, and other comorbidities associated with elevated serum potassium. The data indicates that hyperkalemia affects approximately 2-3% of the general population, with higher incidence among CKD patients and those on potassium-retaining medications [1]. The market's expansion correlates with demographic trends, especially aging populations, and rising awareness of hyperkalemia's sequelae.

SZC occupies a significant niche within the potassium management landscape, acting as a second-generation potassium binder with a rapid onset of action, minimal absorption, and favorable safety profile. Its unique crystal-based mechanism provides an advantage over older therapies like sodium polystyrene sulfonate (SPS), which has been marred by safety concerns.

Market Drivers

1. Rising Prevalence of Hyperkalemia

The increasing burden of CKD, heart failure, and diabetes significantly contributes to hyperkalemia cases. As CKD prevalence exceeds 10% worldwide, the need for effective potassium management intensifies [2]. The incremental aging of populations in North America, Europe, and parts of Asia further amplifies this trend.

2. Therapeutic Limitations and Unmet Needs

Traditional treatments such as SPS suffer from inconsistent efficacy and safety issues, including gastrointestinal adverse events and potential for severe complications. SZC addresses these gaps, offering predictable potassium reduction with a low adverse event profile, thereby fostering clinician adoption.

3. Expanded Indications and Usage

Beyond hyperkalemia episodes, recent clinical data suggest prophylactic use in patients on RAAS inhibitors and other medications that elevate hyperkalemia risk [3]. Such extensions broaden market potential.

4. Favorable Regulatory Environment

Post-approval, SZC received favorable label updates in various jurisdictions, with the FDA approving its use in both acute and chronic settings. Health authorities recognize its safety benefits over older therapies, encouraging formulary inclusion.

5. Pricing Strategies and Reimbursement

Premium pricing, driven by its novel mechanism and clinical benefits, enhances revenue potential. Negotiations with insurers and inclusion in national formulary lists underpin sustainable reimbursement pathways.

Market Challenges

1. Competitive Landscape

The hyperkalemia management space is increasingly competitive, with generic potassium binders and emerging therapies converging. Notably, patiromer (Veltassa) is a key competitor, with similar indications but differing pharmacokinetics and safety profiles [4].

2. Clinical Adoption Barriers

Physician familiarity, treatment guidelines, and clinical inertia can affect uptake rates. Demonstrating cost-effectiveness and positioning SZC as first-line therapy is critical.

3. Patent and Patent Expiry Risks

Patents related to SZC expand exclusivity; however, generic competition could emerge within the next decade, potentially exerting downward pressure on prices.

4. Cost and Reimbursement Constraints

Budgetary constraints, especially within public health programs, could limit access, emphasizing the importance of demonstrating value.

Financial Trajectory

Revenue Generation and Growth

Since launching, SZC has experienced robust sales growth, driven by expanding indications and geographic expansion. For example, Novartis, the manufacturer, reported net sales of $XXX million in 2022, reflecting a XX% increase from 2021 [5]. The anticipated CAGR for the hyperkalemia market is projected at X% over the next five years, further bolstering SZC revenues.

Market Penetration Strategies

Aggressive marketing, education initiatives targeting nephrologists and cardiologists, and inclusion in clinical guidelines propel market penetration. Successful collaborations with health systems facilitate formulary acceptance.

Geographic Expansion

Initial sales were concentrated in North America; subsequent launches in Europe, Asia-Pacific, and other high-growth regions have contributed significantly to revenue streams. Tailored market entry strategies considering local healthcare systems influence financial outcomes.

Research & Development Investment

Ongoing investments in real-world evidence and additional clinical trials aim to expand indications and optimize dosing regimens. Such R&D spending is expected to sustain long-term revenue growth and market position.

Profitability Outlook

While high development and marketing costs impact short-term margins, economies of scale and increased market share are projected to enhance profitability. The persistent demand for effective hyperkalemia therapy supports a positive financial outlook.

Regulatory and Patent Considerations

Regulatory approvals in multiple jurisdictions augment commercialization pathways. Patent protections, including formulation patents extending into the 2030s, help defend market share. Nonetheless, patent challenges or the advent of biosimilar products could influence future financial trajectories.

Future Market Trends

• Personalized Medicine: Integration of genetic testing and biomarker-based approaches to tailor hyperkalemia management enhances market segments.
• Digital Health Integration: Telemedicine and adherence monitoring tools improve patient outcomes and medication compliance, indirectly elevating SZC sales.
• Emerging Therapies: Investigational agents, such as gene therapies or novel oral agents, could disrupt the landscape but currently remain in early development stages.

Key Opportunities and Risks

Opportunities	Risks
Expansion into prophylactic use	Competition from novel therapies
Growing geriatric population	Patent expiries and generic entries
New geographic markets	Regulatory hurdles in certain regions
Clinical guideline endorsements	Market pricing pressures

Conclusion

Sodium zirconium cyclosilicate stands at the forefront of hyperkalemia management innovation, with a compelling market growth trajectory driven by demographic shifts, unmet clinical needs, and regulatory support. While challenges like competition and reimbursement barriers exist, strategic positioning, ongoing clinical research, and geographic expansion will underpin its financial trajectory. Continuous monitoring of market trends and stakeholder engagement remain vital for optimizing commercial success.

Key Takeaways

• The hyperkalemia market is expanding due to rising CKD and heart failure prevalence, positioning SZC for sustained growth.
• Clinical advantages over older therapies, such as safety and efficacy, bolster SZC’s market adoption.
• Competition from established drugs like patiromer and emerging therapies necessitates differentiation and evidence of cost-effectiveness.
• Revenue growth is supported by broadening indications, geographic expansion, and strategic partnerships.
• Maintaining patent strength and navigating reimbursement landscapes are crucial to securing long-term financial stability.

FAQs

1. What distinguishes sodium zirconium cyclosilicate from older potassium binders?
SZC offers rapid, predictable serum potassium reduction, with a favorable safety profile, minimal gastrointestinal side effects, and no significant systemic absorption, contrasting with older agents like SPS, which have safety concerns and variable efficacy [1].

2. How does the competitive landscape influence SZC’s market potential?
With rivals such as patiromer, and emerging treatments in early development, SZC must emphasize clinical advantages, cost-effectiveness, and guideline endorsements to sustain and grow its market share [4].

3. What are the key factors driving future revenue growth for SZC?
Market expansion into prophylactic applications, increased adoption in new geographical markets, and inclusion in treatment guidelines are primary drivers of future revenue growth [2].

4. How might patent expirations affect SZC’s financial outlook?
Patent expiry risks could lead to generic competition, exerting downward price pressure. Strategic patent filings and lifecycle management are essential for maintaining profitability [5].

5. What strategic initiatives are critical for maximizing SZC's market success?
Investing in clinical research to expand indications, engaging healthcare providers through education, optimizing payer relationships, and expanding globally are pivotal strategies [3].

---

References

1. [1] Food and Drug Administration. FDA approves Lokelma for treating hyperkalemia. 2018.
2. [2] Global Data. Hyperkalemia Market Analysis and Forecasts. 2022.
3. [3] ClinicalTrials.gov. Clinical studies involving sodium zirconium cyclosilicate. 2023.
4. [4] Market Watch. Competition in the potassium binders market. 2022.
5. [5] Novartis Annual Report. Financial highlights and pipeline. 2022.