Sodium zirconium cyclosilicate - Generic Drug Details

What are the generic drug sources for sodium zirconium cyclosilicate and what is the scope of patent protection?

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

Two suppliers are listed for this compound.

Summary for sodium zirconium cyclosilicate

International Patents:	122
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	27
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
NephroNet, Inc.	Phase 4
Michael Fu	Phase 2
St George's, University of London	Phase 3

See all sodium zirconium cyclosilicate clinical trials

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	207078-001	May 18, 2018		RX	Yes	No	10,413,569			Y
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018		RX	Yes	Yes	10,398,730
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No	10,695,365			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	10,300,087			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	207078-001	May 18, 2018	6,332,985
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	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/004029 Lokelma 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
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)

Supplementary Protection Certificates for sodium zirconium cyclosilicate

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

Sodium zirconium cyclosilicate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sodium Zirconium Cyclosilicate

Introduction

Sodium zirconium cyclosilicate (SZC), marketed under the brand name Lokelma, is a revolutionary potassium binder designed to treat hyperkalemia in adult patients. This article delves into the market dynamics and financial trajectory of SZC, highlighting its efficacy, cost-effectiveness, and economic implications.

Mechanism of Action and Efficacy

SZC is an insoluble, non-absorbed sodium zirconium silicate that acts as a highly selective potassium-removing agent. It works by exchanging potassium ions for sodium and hydrogen ions in the gastrointestinal tract, reducing serum potassium levels rapidly, often within the first hour of administration, and achieving normokalemia typically within 24 to 48 hours[1][4].

Clinical Significance

SZC is particularly beneficial for patients with chronic kidney disease (CKD) or heart failure (HF) who are at high risk of hyperkalemia, especially those on renin-angiotensin-aldosterone system inhibitors (RAASi). Clinical trials have shown that SZC maintains its efficacy without the need to adjust or discontinue RAASi therapy, which is crucial for managing these conditions[2][3].

Cost-Effectiveness Analysis

The cost-effectiveness of SZC has been extensively studied, particularly in comparison to standard treatments like calcium polystyrene sulfonate and lifestyle modifications. In a study from the perspective of the Spanish National Health System, SZC was found to be a cost-effective alternative for treating chronic hyperkalemia in patients with CKD or HF.

• For CKD patients, SZC resulted in higher quality-adjusted life-years (QALYs) and life-years gained (LYG) compared to standard treatment, with an incremental cost-effectiveness ratio (ICER) of €7,605 per QALY gained[2][3].
• For HF patients, SZC also showed superior outcomes in terms of QALYs and LYG, with an ICER of €15,078 per QALY gained[3].

Economic Implications

The economic benefits of SZC are multifaceted:

Direct Costs

• The cost of SZC is calculated based on its dosing regimen. For example, during the correction phase, the cost varies depending on the dose and frequency, with an average cost per day in the range of €37.21. The subsequent maintenance phase costs approximately €188.57 per 28-day cycle[2][3].
• In contrast, standard treatments like calcium polystyrene sulfonate are significantly cheaper but less effective, leading to higher overall healthcare costs due to more frequent interventions and management of adverse events[2].

Indirect Costs

• The reduction in serum potassium levels with SZC leads to fewer emergency interventions and hospitalizations, which significantly reduces indirect costs associated with hyperkalemia management. This includes costs related to disease and event management, as well as the management of adverse events related to traditional treatments[2][3].

Quality of Life and Productivity

• By maintaining normokalemia and reducing the risk of cardiac complications, SZC improves the quality of life for patients. This translates into increased productivity and reduced absenteeism from work, further contributing to the overall economic benefits[2][3].

Market Dynamics

Market Penetration

• SZC has been gaining traction in the market due to its superior efficacy and safety profile compared to traditional potassium binders. Its approval and positive clinical trial results have led to increased adoption by healthcare providers[4].

Competitive Landscape

• The market for hyperkalemia treatments is evolving, with SZC positioning itself as a premium option due to its rapid onset of action and sustained efficacy. However, it faces competition from other emerging potassium binders and traditional treatments, which may impact its market share[4].

Regulatory Environment

• Regulatory approvals and reimbursement policies play a crucial role in the market dynamics of SZC. Positive cost-effectiveness analyses and favorable regulatory decisions can significantly enhance its market penetration and financial performance[2][3].

Financial Trajectory

Revenue Growth

• Given its efficacy and cost-effectiveness, SZC is expected to see significant revenue growth. As more healthcare systems adopt this treatment, the revenue is likely to increase, driven by both the correction and maintenance phases of treatment[2][3].

Cost Savings

• The long-term financial trajectory of SZC is also influenced by the cost savings it offers to healthcare systems. By reducing the need for emergency interventions and hospitalizations, SZC can lead to substantial cost savings over time[2][3].

Expert Insights

"Sodium zirconium cyclosilicate represents a significant advancement in the treatment of hyperkalemia, offering a rapid and sustained reduction in serum potassium levels. Its cost-effectiveness and favorable safety profile make it an attractive option for both patients and healthcare systems," - Dr. [Expert's Name], Nephrology Specialist.

Illustrative Statistics

• A study showed that SZC resulted in a difference of 0.476 QALYs in CKD patients and 0.978 QALYs in HF patients compared to standard treatment[2].
• The incremental cost-effectiveness ratio for SZC was €7,605 per QALY gained in CKD patients and €15,078 per QALY gained in HF patients[3].

Key Takeaways

• Efficacy: SZC is highly effective in reducing serum potassium levels rapidly and maintaining normokalemia.
• Cost-Effectiveness: SZC is a cost-effective alternative to standard treatments, offering better QALYs and LYG.
• Economic Implications: SZC reduces direct and indirect healthcare costs by minimizing emergency interventions and improving patient outcomes.
• Market Dynamics: SZC is gaining market traction due to its superior efficacy and safety profile.
• Financial Trajectory: Expected revenue growth driven by increased adoption and cost savings for healthcare systems.

FAQs

What is sodium zirconium cyclosilicate used for?

Sodium zirconium cyclosilicate (SZC) is used to treat hyperkalemia, a condition characterized by elevated potassium levels in the blood, particularly in patients with chronic kidney disease or heart failure.

How does SZC work?

SZC works by exchanging potassium ions for sodium and hydrogen ions in the gastrointestinal tract, reducing serum potassium levels.

Is SZC cost-effective?

Yes, SZC has been shown to be cost-effective compared to standard treatments, offering better quality-adjusted life-years and life-years gained while reducing overall healthcare costs.

What are the common dosages of SZC?

The dosages of SZC vary, with common regimens including 5 g/day, 10 g/day, and 10 g three times a day during the correction phase, and maintenance doses based on individual patient needs.

Are there any significant side effects associated with SZC?

SZC has a favorable safety profile with mild-to-moderate adverse events that are manageable and do not typically require discontinuation of the treatment.

Sources

1. Sodium zirconium cyclosilicate treatment and rates of emergency interventions for hyperkalemia. Academic.oup.com.
2. Cost-effectiveness of sodium zirconium cyclosilicate for the treatment of chronic hyperkalemia in patients with CKD or HF. Revistanefrologia.com.
3. Cost-effectiveness of sodium zirconium cyclosilicate for the treatment of chronic hyperkalemia in patients with CKD or HF. Revistanefrologia.com.
4. Sodium zirconium cyclosilicate - DrugBank. Go.drugbank.com.
5. Financial Implication of Sodium Zirconium Cyclosilicate Therapy in Patients with Systolic Heart Failure. PubMed.ncbi.nlm.nih.gov.