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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 twenty-two patent family members in thirty-five 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 two 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.

Indicators of Generic Entry

Summary for LOKELMA

International Patents:	122
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	7
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
NephroNet, Inc.	Phase 4
Michael Fu	Phase 2
St George's, University of London	Phase 3

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/004029 Lokelma 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	COMPOSITIONS DE SILICATE DE ZIRCONIUM A USAGE PROLONGE ET PROCEDES D'UTILISATION CORRESPONDANTS (EXTENDED USE ZIRCONIUM SILICATE COMPOSITIONS AND METHODS OF USE THEREOF)
Eurasian Patent Organization	035890	КОМПОЗИЦИИ НА ОСНОВЕ СИЛИКАТА ЦИРКОНИЯ ДЛЯ ЛЕЧЕНИЯ ГИПЕРКАЛИЕМИИ (ZIRCONIUM SILICATE COMPOSITIONS FOR TREATING HYPERKALEMIA)
Canada	2929978
Israel	258478	שימוש מורחב בתרכובות זירקוניום סיליקוניות ושיטות לשימושן (Extended use zirconium silicate compositions and methods of use thereof)
Israel	237905
China	106170283	用于治疗高钾血症的微孔硅酸锆 (Microporous zirconium silicate for the treatment of hyperkalemia)
South Africa	201502186	MICROPOROUS ZIRCONIUM SILICATE FOR TREATING HYPERKALEMIA

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
2203431	15C0013	France		PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
0480717	98C0022	France		PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
1499331	SPC/GB13/034	United Kingdom		PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
0579826	SPC/GB02/042	United Kingdom		PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
2203431	2015/009	Ireland		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115

LOKELMA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lokelma

Introduction to Lokelma

Lokelma, also known as sodium zirconium cyclosilicate, is a potassium binder drug developed by AstraZeneca for the treatment of hyperkalemia, a condition characterized by elevated potassium levels in the blood. Since its approval in 2018, Lokelma has been a significant player in the hyperkalemia treatment market.

Market Overview

The hyperkalemia treatment market, in which Lokelma operates, is expected to experience robust growth. This market is projected to register a Compound Annual Growth Rate (CAGR) of 16.79% over the forecast period from 2024 to 2029. The increasing prevalence of hyperkalemia, particularly among the aging population and those with chronic kidney disease, drives this growth[1].

Regional Market Performance

North America, led by the United States, is anticipated to hold a significant share in the hyperkalemia treatment market. The region's growth is driven by factors such as increased healthcare expenditure, ongoing research and development, and the rising prevalence of hyperkalemia. The Asia-Pacific region, however, is expected to be the fastest-growing market over the forecast period[1].

Financial Performance of Lokelma

Revenue Growth

Lokelma has shown steady revenue growth since its approval. In 2022, the drug generated $289 million in annual sales. By the third quarter of 2023, this figure had increased to $300 million for the first nine months of the year. GlobalData predicts that worldwide sales of Lokelma will rise to $799 million by 2029[4].

Market Impact

Despite initial expectations that Lokelma would be a blockbuster drug, its sales have not yet reached those heights. However, the drug continues to gain traction, particularly in its approved indication for managing hyperkalemia in patients with chronic kidney disease (CKD) and heart failure.

Clinical Trials and Development

AstraZeneca has been conducting various clinical trials to expand the evidence base for Lokelma's use across different cardiorenal conditions. However, two Phase III "evidence" trials, STABILIZE-CKD and DIALIZE-Outcomes, were recently discontinued due to slow enrollment and low clinical event rates. This decision was not based on safety concerns and does not affect the drug's current approved indication[4].

Clinical Evidence and Value

Recent studies have highlighted the value of Lokelma in clinical practice. For instance, evidence presented in November 2023 indicated that Lokelma more than doubled the odds of patients with CKD or heart failure to maintain their ability to stay on lifesaving renin-angiotensin-aldosterone system inhibitor (RAASi) therapy compared to those not on a potassium binder treatment[4].

Competitive Landscape

The hyperkalemia treatment market is relatively consolidated, with a few key players dominating the scene. AstraZeneca, along with other major companies like Sanofi SA, Perrigo Company PLC, CSL Limited (Vifor Pharma Management Ltd.), and Ardelyx, are among the leading players in this market[1].

Financial Trajectory of AstraZeneca

AstraZeneca's overall financial performance provides context for Lokelma's growth. In the first half of 2024, AstraZeneca reported an 18% increase in total revenue to $25,617 million, driven by an 18% increase in product sales and continued growth in alliance revenue from partnered medicines. The company's core product sales gross margin remained stable at 82%, and the core operating margin was 33%[2][5].

Future Outlook

Despite the discontinuation of the two Phase III trials, Lokelma's future outlook remains positive. The drug's established efficacy and the growing demand for hyperkalemia treatments are expected to drive its sales. AstraZeneca's continued investment in research and development, as well as its strong pipeline of potential new medicines, further supports the company's long-term growth strategy[3][4].

Key Takeaways

• Revenue Growth: Lokelma's revenue has been increasing steadily, with predictions of reaching $799 million by 2029.
• Clinical Evidence: The drug has shown significant clinical value, particularly in maintaining RAASi therapy in patients with CKD or heart failure.
• Market Dynamics: The hyperkalemia treatment market is growing rapidly, driven by increasing prevalence and research focus.
• Competitive Landscape: AstraZeneca is one of the key players in a relatively consolidated market.
• Financial Performance: AstraZeneca's overall financial health supports the continued growth and development of Lokelma.

FAQs

What is the current market size of the hyperkalemia treatment market?

The hyperkalemia treatment market is projected to register a CAGR of 16.79% during the forecast period (2024-2029), with North America holding the largest market share[1].

Who are the major players in the hyperkalemia treatment market?

Key players include Sanofi SA, Perrigo Company PLC, CSL Limited (Vifor Pharma Management Ltd.), AstraZeneca, and Ardelyx[1].

What are the factors driving the growth of the hyperkalemia treatment market?

The market is driven by the increasing prevalence of hyperkalemia, rising focus on research and development, and increased healthcare expenditure, particularly in North America[1].

Why were the Phase III trials for Lokelma discontinued?

The trials were discontinued due to slow enrollment and low clinical event rates, but this decision was not based on safety concerns and does not affect the drug's current approved indication[4].

What is the predicted future revenue for Lokelma?

GlobalData predicts that worldwide sales of Lokelma will increase to $799 million by 2029[4].

Sources

1. Mordor Intelligence: Hyperkalemia Treatment Market - Size, Share & Industry Analysis
2. Business Wire: AstraZeneca's H1 and Q2 2024 Financial Results
3. AstraZeneca: Full year and Q4 2022 results | AstraZeneca
4. BioSpace: AstraZeneca Axes Two Phase III Hyperkalemia Trials for Lokelma
5. AstraZeneca: H1 and Q2 2024 results Strong Financial Performance and Pipeline Progress