LOKELMA Drug Patent Profile

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

Lokelma is a drug marketed by Astrazeneca and is included in one NDA. There are fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-one patent family members in thirty-eight countries.

The generic ingredient in LOKELMA is sodium zirconium cyclosilicate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium zirconium cyclosilicate profile page.

DrugPatentWatch^® Generic Entry Outlook for Lokelma

Lokelma was eligible for patent challenges on May 18, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 14, 2035. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (sodium zirconium cyclosilicate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for LOKELMA

International Patents:	131
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	8
Patent Applications:	18
Drug Prices:	Drug price information for LOKELMA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LOKELMA
What excipients (inactive ingredients) are in LOKELMA?	LOKELMA excipients list
DailyMed Link:	LOKELMA at DailyMed

See drug prices for LOKELMA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LOKELMA

Constraining patent/regulatory exclusivity:

9,592,253

NDA:

207078

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 LOKELMA

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

Sponsor	Phase
Fundación para la Investigación del Hospital Clínico de Valencia	PHASE3
NephroNet, Inc.	Phase 4
AstraZeneca	Phase 2

See all LOKELMA clinical trials

Paragraph IV (Patent) Challenges for LOKELMA

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 LOKELMA

LOKELMA is protected by fourteen US patents.

This potential generic entry date is based on patent 9,592,253.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	9,592,253			Y
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018		RX	Yes	Yes	10,300,087			Y
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018		RX	Yes	Yes	10,695,365			Y
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No	9,913,860			Y
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No	10,398,730
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No	8,802,152			Y

Expired US Patents for LOKELMA

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 LOKELMA

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 LOKELMA

When does loss-of-exclusivity occur for LOKELMA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Costa Rica

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

Philippines

South Africa

South Korea

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LOKELMA around the world.

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
Australia	2016338753	Extended use zirconium silicate compositions and methods of use thereof

Supplementary Protection Certificates for LOKELMA

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
1856135	LUC00153	Luxembourg		PRODUCT NAME: FOSTAMATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, OU UN HYDRATE, SOLVATE OU N-OXYDE DE FOSTAMATINIB OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, EN PARTICULIER FOSTAMATINIB DISODIUM, EVENTUELLEMENT SOUS FORME D'HYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113

Market Dynamics and Financial Trajectory for LOKELMA (Sodium Zirconium Cyclosilicate)

Last updated: July 27, 2025

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Introduction

LOKELMA (sodium zirconium cyclosilicate) stands as a notable therapeutic agent in the management of hyperkalemia, a condition characterized by elevated serum potassium levels. Approved by the U.S. Food and Drug Administration (FDA) in 2018, LOKELMA has positioned itself within a niche therapeutic landscape, targeting a significant clinical need with substantial market potential. Its market dynamics and financial trajectory are shaped by a confluence of factors including clinical efficacy, competitive landscape, regulatory pathways, healthcare policies, and evolving patient demographics.

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Market Landscape and Demand Drivers

Hyperkalemia as an Increasing Clinical Concern

Hyperkalemia remains a common complication among patients with chronic kidney disease (CKD), heart failure, and diabetes mellitus—diseases with rising prevalence globally (approximately 10-15% of the adult population in developed countries). The aging population further amplifies the incidence of these conditions, thus expanding the pool of patients susceptible to hyperkalemia. Traditionally, treatments involved off-label use of potassium binders like sodium polystyrene sulfonate, which posed safety and efficacy concerns. LOKELMA provides a more targeted, safer alternative with demonstrated efficacy, creating a compelling demand.

Clinical Adoption and Prescriber Dynamics

Since its launch, LOKELMA’s adoption has increased in outpatient and inpatient settings, especially among cardiologists, nephrologists, and internists. Its ease of administration (oral powder formulation) and improved safety profile have facilitated integration into treatment regimens. However, delayed or cautious adoption persists mainly due to clinician familiarity with existing therapies and concerns over cost-effectiveness.

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Competitive Landscape

Key Competitors

• Patiromer (Veltassa): Launched in 2015, Patiromer was the first novel potassium binder approved in the U.S., and remains a primary competitor. While both agents are effective, differences in onset of action and safety profiles influence prescriber choice.

• Sodium Polystyrene Sulfonate (SPS): An older, widely used therapy with safety concerns like gastrointestinal toxicity, limiting its preference despite lower cost.

• Emerging Therapies: Upcoming agents and innovations in dialysis-based strategies or novel oral agents could influence the market trajectory.

Market Share Dynamics

LOKELMA captured a significant early market share owing to its regulatory approval and favorable safety profile. Nonetheless, Patiromer’s longer market presence and entrenched prescribing habits sustain competitive pressure. The degree of market penetration hinges on clinical outcomes, pricing strategies, and formulary inclusions.

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Regulatory and Reimbursement Factors

Pricing and Cost-Effectiveness

Pricing strategies for LOKELMA are pivotal. The drug’s list price (~$600 per month in the U.S.) is positioned above older therapies but reflects its advanced safety profile and manufacturing costs. Medicare and insurance coverage influence patient access, and payor policies impact prescribing patterns.

Reimbursement and formulary placements

Inclusion on major formularies and reimbursement schemes enhances market penetration. Favorable coverage decisions by CMS (Centers for Medicare & Medicaid Services) and other insurers can accelerate uptake, particularly among high-risk patient populations.

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Clinical Trends and Patient Outcomes

Kinetic Advantages and Safety Profile

LOKELMA offers rapid serum potassium reduction within 1 hour, with sustained effect. Its safety profile reduces risks of gastrointestinal adverse events, a substantial benefit over traditional binders. As clinicians prioritize safety in chronic management, LOKELMA’s utility is expected to grow.

Integration into Treatment Guidelines

Guidelines from organizations like the American Heart Association and Kidney Disease Improving Global Outcomes (KDIGO) are increasingly endorsing newer potassium binders, reinforcing LOKELMA’s clinical relevance and expanding its user base.

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Financial Trajectory and Market Forecasts

Market Revenue Projections

Based on current data, the global hyperkalemia treatment market is projected to reach $900 million by 2025, with LOKELMA accounting for approximately 40-60% of this segment due to its growing market share. Market analysts predict a compound annual growth rate (CAGR) of ~10% for LOKELMA over the next five years, driven by increased prevalence of target conditions and positive clinical outcomes data.

Factors Influencing Revenue Growth

• Expanding indications: Potential approval for prophylactic use or outpatient management could broaden LOKELMA’s application scope.
• Market penetration: Investment in physician education and formulary negotiations will enhance adoption.
• Pricing strategy: Balancing affordability with profitability remains crucial; innovative discounting or patient assistance programs may facilitate broader access.
• Pipeline developments: The introduction of next-generation binders or combination therapies might challenge or complement LOKELMA’s position.

Global Market Opportunities

While currently primarily marketed in the U.S. and select regions, expansion into Europe and Asia-Pacific represents significant future revenue streams, particularly with increasing CKD and cardiac disease prevalence in these regions.

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Challenges and Risks

• Pricing and reimbursement hurdles: High list prices may limit access, particularly in regions with strict cost-containment policies.
• Competitive pressure: The entry of alternative therapies or generics post-patent expiry can erode market share.
• Regulatory shifts: Changes in approval frameworks or safety regulations could impact product lifecycle.

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Conclusion

LOKELMA’s market dynamics are influenced by its clinical advantages, evolving treatment landscape, and healthcare ecosystem complexities. Its financial trajectory, characterized by sustained growth and expanding application, hinges on successful market penetration, pricing competitiveness, and navigating regulatory environments. Strategic collaborations, educational initiatives, and pipeline innovation will determine its long-term market position.

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Key Takeaways

• Growing demand for safe and effective hyperkalemia management drives LOKELMA’s market expansion.
• Competitive positioning depends on efficacy, safety profile, and formulary inclusions relative to established therapies like Patiromer and SPS.
• Pricing strategies and reimbursement policies significantly influence patient access and revenue potential.
• Clinical guideline endorsements and real-world evidence are pivotal for sustained adoption.
• Pipeline developments and geographic expansion offer substantial upside prospects but pose competitive and regulatory risks.

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FAQs

1. What are the primary advantages of LOKELMA over older potassium binders?
LOKELMA provides rapid serum potassium reduction, a favorable safety profile with fewer gastrointestinal adverse events, and easier oral administration, making it a preferred choice in many clinical settings.

2. How does LOKELMA’s pricing impact its market adoption?
While priced higher than older agents, its safety and efficacy justify the cost in many cases. Reimbursement policies and patient assistance programs are essential to improve access and adoption.

3. What are the potential future indications for LOKELMA?
Researching its prophylactic use, outpatient management, and combination strategies with other therapies could expand its clinical utility.

4. How does the competitive landscape influence LOKELMA’s financial outlook?
Dominance of Patiromer and emerging therapies creates competitive pressure, but LOKELMA’s unique benefits can sustain its market share through strategic positioning.

5. What factors could challenge LOKELMA’s long-term market growth?
Patent expiration, pricing pressures, regulatory changes, and competition from alternative therapies pose risks to sustained growth.

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References

1. U.S. Food & Drug Administration. (2018). FDA approves new drug to treat hyperkalemia.
2. MarketWatch. (2022). Hyperkalemia treatment market forecast and analysis.
3. Clinicaltrials.gov. (2021). Ongoing studies on potassium binders.
4. IQVIA. (2023). Prescription Trends in Hyperkalemia Management.
5. FDA Drug Approval Documents for LOKELMA.