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

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
Göteborg University	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.

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				Y
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018		RX	Yes	Yes				Y
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018		RX	Yes	Yes				Y
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No				Y
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No				Y
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018		RX	Yes	Yes

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	207078-001	May 18, 2018
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018

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
Canada	3000950
Philippines	12016500864
Australia	2012214224	Microporous zirconium silicate for the treatment of hyperkalemia
Israel	237905	צירקוניום סיליקאט המכיל נקבוביות מיקרו לטיפול בהיפרקאלמיה (Microporous zirconium silicate for treating hyperkalemia)
European Patent Office	3470370	SILICATE DE ZIRCONIUM MICROPOREUX POUR LE TRAITEMENT DE L'HYPERKALÉMIE (MICROPOROUS ZIRCONIUM SILICATE FOR THE TREATMENT OF HYPERKALEMIA)
Taiwan	201607543	Microporous zirconium silicate for the treatment of hyperkalemia
Lithuania	2673237

Supplementary Protection Certificates for LOKELMA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1666481	17C1031	France		PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
1948158	93075	Luxembourg		PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN, C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3'-METHYL-2-(PENTANYOL(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE) DE TRISODIUM HEMIPENTAHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
2673237	122019000036	Germany		PRODUCT NAME: NATRIUMZIRCONIUMCYCLOSILICAT; REGISTRATION NO/DATE: EU/1/17/1173 20180322
2822954	SPC/GB18/031	United Kingdom		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625
2203431	CA 2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
1856135	2020/017	Ireland		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REGISTRATION NO/DATE: EU/1/19/1405 20200113

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

Last updated: December 25, 2025

Executive Summary

Lokelma (sodium zirconium cyclosilicate), developed by AstraZeneca, is a potassium-binding agent approved by the FDA in 2018 for hyperkalemia treatment. The drug has seen increasing adoption driven by rising hyperkalemia prevalence amid shifting demographic and clinical landscapes. This analysis examines the market environment, key drivers, competitive positioning, revenue prospects, regulatory influences, and future outlook.

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What is Lokelma & How Does It Fit in the Hyperkalemia Treatment Landscape?

Attribute	Details
Generic Name	Sodium zirconium cyclosilicate
Brand Name	Lokelma (US), Lokelma (EU)
Indication	Treatment of hyperkalemia in adults
Mechanism	Potassium binder that exchanges sodium and hydrogen ions for potassium in gastrointestinal tract
Approval Dates	FDA (2018), EMA (2019)
Administration	Oral powder, once daily
Pricing (approximate)	~$4000–$5500/year per patient (US)

Lokelma is positioned among potassium binders, with competitors including Veltassa (patiromer) and older agents like sodium polystyrene sulfonate, whose safety and efficacy profiles differ.

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What Are the Key Market Drivers?

1. Rising Hyperkalemia Prevalence

• Global hyperkalemia prevalence is estimated at 3.7%, with higher rates among patients with CKD, heart failure, and those on RAAS inhibitors (e.g., ACE inhibitors, ARBs, MRAs) [1].
• The aging population and chronic disease burden escalate hyperkalemia cases.
• In the US, hyperkalemia hospitalizations increased by 14% from 2016 to 2020.

2. Growing Use of RAAS Inhibitors

• RAAS inhibitors are cornerstone therapies for heart failure, hypertension, CKD but elevate hyperkalemia risk.
• A shift towards tolerating RAAS inhibitors at optimal doses, facilitated by effective potassium management regimens, amplifies lokelma's market potential.

3. Adoption of New Hyperkalemia Management Guidelines

• Recent guidelines emphasize rapid correction of hyperkalemia, favoring newer potassium binders over older, riskier options.
• NICE (UK), ESC (Europe), and ACC (US) recognize potassium binders as critical adjuncts.

4. Increased Awareness and Physician Preference

• Demonstrated safety profile, convenience, and efficacy have promoted broader adoption.
• Favorable data from phase III trials show that lokelma can safely normalize potassium within 24 hours with sustained effects [2].

5. Payer and Reimbursement Policies

• In the US, insurance coverage for newer agents like lokelma is expanding.
• Cost-effectiveness analyses for hyperkalemia management identify potential reductions in hospitalizations, influencing payer decisions.

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What Are Competitive Dynamics?

Agent	Mechanism	Approval Year	Safety Profile	Market Share (Estimated)	Key Differentiators
Lokelma	Sodium zirconium cyclosilicate	2018 (FDA)	Favorable	~50% (US)	Rapid onset, minimal GI side effects, once-daily dosing
Veltassa	Patiromer	2015 (FDA)	Favorable	~30–40% (US)	Longer half-life, used in chronic management
Sodium Polystyrene Sulfonate	Resin-based	Oldest; decades	Concerns over safety	Declining	Cost-effective but less safe, variable efficacy

Market share and preference vary based on region, formulary inclusion, and clinician familiarity.

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What Is the Financial Trajectory for Lokelma?

Revenue Trends and Projections

Year	Estimated Revenue (US$ million)	Growth Rate	Commentary
2018	~$50	—	Launch year, limited awareness
2019	~$150	200%	Increased adoption, expanded indications
2020	~$300	100%	Market penetration, guideline alignment
2021	~$500	66.7%	Payer coverage, broader clinical use
2022	~$700	40%	Continued growth, regional expansion
2023 (forecast)	~$900–$1,000	28–43%	Penetration into new markets, COVID-19 normalization

Note: These estimates are indicative; actual revenues are subject to market access and competitive forces.

Factors Influencing Revenue Growth

• Expanding Indications: Utilization in chronic heart failure, CKD stages.
• Geographical Expansion: Entry into Asian and Latin American markets.
• Pricing Dynamics: Negotiations with payers, biosimilar/market entry influences.
• Patent and Market Exclusivity: Patents expected to last until mid-2030s, buffering generic competition.

Pricing and Reimbursement Considerations

Region	Pricing (Approximate USD/year)	Reimbursement Policies
US	$4,500–$5,500	Medicare & private insurers, PAMs coverage varies
EU	€3,700–€4,600	National health services, national formularies
Asia	Varies widely	Emerging reimbursement mechanisms

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How Do Regulatory Policies Impact Market Trajectory?

1. Approval of New Indications

• Expanding approval for maintenance therapy or specific comorbidities could boost sales.

2. Reimbursement Policies

• Favorable coverage accelerates adoption; restrictive policies hinder market growth.

3. Price Negotiations & Centralized Tendering

• Price reductions via tendering in healthcare systems (e.g., UK NHS, Germany) could impact gross margins but enhance access.

4. Post-Marketing Safety Data

• Ongoing pharmacovigilance influences regulatory status and physician confidence.

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Future Outlook: What Is the Expected Market Evolution?

Market Penetration Scenarios

Scenario	Assumptions	Estimated Revenue (2025)	Market Share
Optimistic	Broad indications, rapid uptake, aggressive pricing	~$1.5 billion	60% of potassium binder market
Moderate	Steady growth, limited indications	~$1 billion	50%
Conservative	Slow adoption, competition intensifies	~$700 million	40%

Key Growth Catalysts

• Increasing prevalence of CKD and cardiovascular diseases.
• Adoption into treatment guidelines.
• Expansion into hospital and outpatient clinics globally.
• Digital health integration and patient education.

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Comparison With Competitors: Molecular and Market Positioning

Parameter	Lokelma	Veltassa	Alternatives
Onset of Action	1 hour	4 hours	Varies (resins slower)
Dosing Frequency	Once daily	Once daily	Varies
Safety Profile	Well tolerated	Well tolerated	GI side effects, electrolyte disturbance
Market Share (US)	~50%	~40%	Declining

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FAQs

1. What factors influence clinicians' choice between Lokelma and Veltassa?

Clinicians consider onset of action, safety profile, dosing convenience, patient tolerability, and formulary placement. Lokelma's rapidity and tolerability favor its use in acute settings, while Veltassa’s long half-life suits chronic management.

2. How does the cost-effectiveness of Lokelma compare to older therapies?

Studies indicate that Lokelma reduces hospitalization rates associated with hyperkalemia, translating into overall cost savings despite higher drug acquisition costs compared to resin-based agents.

3. Are there any upcoming regulatory updates affecting Lokelma?

Potential expanding indications, such as for chronic management or use in specific populations (e.g., dialysis), are under review or in trials, which may enhance market penetration.

4. What are the primary barriers to Lokelma’s market growth?

Barriers include high drug costs, reimbursement limitations in certain regions, clinician familiarity with older therapies, and competition from generics or alternative modalities.

5. What is the long-term patent outlook for Lokelma?

Current patents extend into the mid-2030s, delaying generic entry. Patent extensions and formulation patents may prolong exclusivity, supporting sustained revenue.

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Key Takeaways

• Rising hyperkalemia prevalence, especially among CKD and heart failure patients, underpins Lokelma’s growth potential.
• Clinical advantages, including rapid onset and favorable safety, position Lokelma favorably over older agents.
• Market expansion into international territories and new indications offers significant upside.
• Competitive landscape favors Lokelma due to better tolerability and convenience, although price and reimbursement negotiations remain vital.
• Revenue projections suggest a trajectory toward $1 billion+ annually within the next three years, contingent on market adoption, regulatory support, and payer policies.

In conclusion, Lokelma’s market dynamics are driven by clinical needs, regulatory trends, and evolving healthcare policies. Strategic positioning and regional expansion will be critical to maximizing its financial trajectory over the coming years.

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References

[1] Kovesdy CP, et al. “Epidemiology of Hyperkalemia in Population-based and Cohort Studies.” Advances in Chronic Kidney Disease, 2017.

[2] Weir MR, et al. “Effect of Sodium Zirconium Cyclosilicate on Potassium in Hyperkalemia Patients: A Phase 3 Trial.” New England Journal of Medicine, 2015.

Note: Revenue forecasts and market share figures are estimative for illustrative purposes based on available market analyses, industry expert reports, and recent sales data.