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-eight 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 22, 2033. 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:	138
US Patents:	14
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LOKELMA

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 8,877,255.

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

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

Croatia

Denmark

European Patent Office

Finland

Hong Kong

Israel

Japan

Lithuania

Mexico

Philippines

Portugal

San Marino

Serbia

Slovenia

South Africa

South Korea

Spain

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
European Patent Office	2673237	UTILISATION D'UN SILICATE DE ZIRCONIUM POUR LE TRAITEMENT DE L'HYPERKALIÉMIE (USE OF A ZIRCONIUM SILICATE FOR THE TREATMENT OF HYPERKALEMIA)
Japan	2017052694
Philippines	12016500864	MICROPOROUS ZIRCONIUM SILICATE FOR THE TREATMENT OF HYPERKALEMIA
Canada	3000950

Supplementary Protection Certificates for LOKELMA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2673237	19C1026	France		PRODUCT NAME: CYCLOSILICATE DE ZIRCONIUM SODIQUE; NAT. REGISTRATION NO/DATE: EU/1/17/1173 20180326; FIRST REGISTRATION: - EU/1/17/1173 20180326
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
2932970	18C1043	France		PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
2673237	LUC00111	Luxembourg		PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1173 20180326

Investment Scenario and Fundamentals Analysis for LOKELMA

Last updated: February 19, 2026

What Is LOKELMA?

LOKELMA (sodium zirconium cyclosilicate) is an oral medication approved for treating hyperkalemia, a condition characterized by elevated potassium levels in the blood. Developed by AstraZeneca, it received FDA approval in 2018. Its mechanism involves binding potassium in the gastrointestinal tract to reduce serum potassium levels.

Market Overview and Competitive Position

Market Size

The global hyperkalemia treatment market was valued at approximately $1.2 billion in 2022 and is projected to reach over $2 billion by 2030, with a compound annual growth rate (CAGR) of roughly 7% (Grand View Research, 2022). The increase stems from aging populations, rising prevalence of chronic kidney disease (CKD), heart failure, and diabetes.

Key Competitors

• Sodium polystyrene sulfonate (Kayexalate): Off-label use, older, less predictable efficacy, potential gastrointestinal side effects.
• Patiromer (Veltassa): Approved in 2017, marketed by Relypsa (acquired by Pfizer in 2019). Has a similar use case with a different mechanism.
• Zirconium hydroxide: Less common, limited applications.

Market Share and Position

LOKELMA holds significant market share due to favorable safety profile, ease of oral administration, and rapid onset. Its higher selectivity and fewer gastrointestinal side effects give it an advantage over older therapies, positioning it as a preferred treatment in hospitals and outpatient settings.

Financial Fundamentals and Revenue Drivers

Revenue Generation

In 2022, AstraZeneca reported LOKELMA revenues of approximately $228 million globally, with US sales accounting for about 60% (AstraZeneca Annual Report, 2022). Growth rates are estimated at 15-20% annually, driven by increased adoption and expanded physician awareness.

Pricing and Reimbursement

• Average wholesale price (AWP): Approximately $300-$400 per month per patient.
• Reimbursement: Reimbursed via Medicare, Medicaid, and private insurers. Reimbursement complexity influences patient access and sales.

R&D and Capital Expenditure

AstraZeneca invests heavily in infrastructure to support commercialization. Development costs for LOKELMA are estimated at $150-$200 million, including clinical trials, regulatory submissions, and manufacturing process improvements.

Regulatory and Patent Landscape

Patent Portfolios

AstraZeneca's key patents for LOKELMA extend until 2030-2035 in major markets. Patent expiry could open the market to generics, impacting pricing and revenues.

Regulatory Approvals

LOKELMA's FDA approval covers the treatment of hyperkalemia in adults, including those with CKD and heart failure. EMA and other jurisdictions have granted approvals, broadening its market access.

Patent Challenges

Potential patent challenges and patent cliffs risk generic entry post-2030. Licenses and biosimilar alternatives may emerge, pressuring prices.

Growth Opportunities

• Expanding indications, such as hyperkalemia in acute settings.
• Geographic expansion into emerging markets.
• Combination therapies with existing cardiovascular drugs.
• Increased use in dialysis and transplant patient populations.

Risks and Challenges

• Patent expiration in 2030-35 could dilute market share.
• Competition from Patiromer, which has demonstrated similar efficacy.
• Pricing pressures from healthcare systems seeking cost reductions.
• Regulatory delays or adverse safety reports affecting market perception.

Investment Outlook

LOKELMA's prospects depend on maintaining clinical efficacy, expanding indications, and market penetration. Growth hinges on AstraZeneca's ability to defend its patent position and expand into untapped markets. The drug demonstrates stable revenue streams, but the aging patent portfolio necessitates planning for patent cliffs.

Key Takeaways

• LOKELMA is a leading hyperkalemia treatment with solid revenue generation, supported by favorable safety and efficacy profiles.
• Market growth is driven by increasing CKD and heart failure prevalence, with expansion potential in emerging markets.
• Patents last until around 2030-2035, after which generic competition may reduce revenues.
• Revenue growth depends on continued adoption, broader indications, and geographic expansion.
• Competition from Patiromer and potential biosimilars pose future risks.

FAQs

1. When will generics for LOKELMA enter the market?
Likely after patent expiry around 2030-2035, depending on patent challenges and exclusivity periods.

2. How does LOKELMA compare to Patiromer?
LOKELMA has a faster onset and a more selective mechanism with fewer gastrointestinal side effects. Pricing and reimbursement strategies influence market share.

3. What are the main regulatory risks?
Delays in approval of new indications or safety concerns can impact market access and revenues.

4. Is there potential for expanding LOKELMA’s indications?
Yes, including acute treatment of hyperkalemia and use in dialysis patients, which could boost sales.

5. What factors influence pricing and reimbursement?
Healthcare policies, competitive landscape, and patient access programs impact revenue potential.

References

[1] Grand View Research. (2022). Hyperkalemia treatment market size and forecast.
[2] AstraZeneca. (2022). Annual report.
[3] US Food and Drug Administration. (2018). FDA approval documents for LOKELMA.