Last Updated: May 2, 2026

Sodium zirconium cyclosilicate - Generic Drug Details


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What are the generic 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 thirty-eight patent family members in thirty-eight countries.

Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for sodium zirconium cyclosilicate
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for sodium zirconium cyclosilicate
Generic Entry Date for sodium zirconium cyclosilicate*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
Mario Negri Institute for Pharmacological ResearchPHASE3
Qianfoshan HospitalPHASE4
Fundación para la Investigación del Hospital Clínico de ValenciaPHASE3

See all sodium zirconium cyclosilicate clinical trials

Generic filers with tentative approvals for SODIUM ZIRCONIUM CYCLOSILICATE
Applicant Application No. Strength Dosage Form
⤷  Start Trial⤷  Start Trial10GPOWDER, FOR SUSPENSION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 207078-002 May 18, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Astrazeneca LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-001 May 18, 2018 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Astrazeneca LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-002 May 18, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Astrazeneca LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-002 May 18, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 207078-002 May 18, 2018 ⤷  Start Trial ⤷  Start Trial
Astrazeneca LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-001 May 18, 2018 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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/004029Lokelma is indicated for the treatment of hyperkalaemia in adult patients. Authorised no no no 2018-03-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for sodium zirconium cyclosilicate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1948158 16C0018 France ⤷  Start Trial PRODUCT NAME: SACUBITRIL/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'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123
0957929 SPC/GB06/021 United Kingdom ⤷  Start Trial PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201
2673237 SPC/GB19/027 United Kingdom ⤷  Start Trial PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; REGISTERED: UK EU/1/17/1173(NI) 20180326; UK PLGB17901/0331-0001 20180326; UK PLGB17902/0332-0001 20180326
1856135 CA 2020 00018 Denmark ⤷  Start Trial 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; REG. NO/DATE: EU/1/19/1405 20200113
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Sodium Zirconium Cyclosilicate: Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

What market does sodium zirconium cyclosilicate address?

Sodium zirconium cyclosilicate (SZC) is an oral, non-absorbed potassium binder used to treat hyperkalemia and support maintenance dosing after initial potassium lowering. Demand is driven by:

  • Chronic kidney disease (CKD) and heart failure populations with recurring hyperkalemia risk from renin-angiotensin-aldosterone system inhibitors and other potassium-elevating regimens
  • Hospital and emergency management of elevated serum potassium where rapid potassium reduction changes disposition and downstream resource use
  • Longer-duration payer interest because maintenance therapy converts an episodic lab abnormality into a recurring treatment pattern

Commercial structure is concentrated around the brand Lokelma in the US and key international markets under Takeda’s ownership and commercialization arrangements (Takeda is the originator and commercial authority in most geographies).


What are the core market dynamics shaping growth?

1) Treatment algorithm shift toward potassium binders

SZC competes with other chronic and acute hyperkalemia strategies, but it has carved a role where rapid onset and tolerability drive clinician preference. Key dynamic is that potassium control becomes a measurable treatment endpoint rather than only “rescue” management, supporting repeat prescribing.

2) Maintenance dosing expands addressable use

Unlike one-off interventions, SZC supports a maintenance concept in which patients continue a binder to keep potassium in range. That changes the commercial math: once stabilized, the patient becomes a recurring demand engine through continued refills and dose adjustments.

3) Reimbursement and formulary penetration

Net sales trajectory depends on:

  • Formulary inclusion within nephrology and cardiology treatment pathways
  • Prior authorization behavior and utilization management tied to baseline potassium criteria and CKD/heart failure diagnoses
  • Copay support and patient access programs that reduce discontinuation risk

4) Competition pressure

The category has multiple players. Competitive dynamics include:

  • Price and rebate positioning among newer oral binders
  • Differentiation on dosing convenience, onset expectations, and adverse event profiles
  • Local payer education and guideline-aligned placement

What is the financial trajectory?

No complete, consistent set of public financial data at the single-product level (SZC/Lokelma net sales by year, segmented by geography) is available in the source set provided in this request. As a result, the product-level financial trajectory cannot be stated with hard year-by-year numbers.

What can be stated as directionally actionable on financial trajectory mechanics, based on commercial drivers:

  • Volume-driven growth is the primary lever because SZC is dosed chronically for maintenance. If prescribing shifts toward maintenance and adherence holds, unit demand compounds.
  • Contracting and reimbursement determine gross-to-net. Increased formulary access typically expands the market faster than it changes wholesale list pricing, so gross-to-net management matters as much as top-line volume.
  • Seasonality and lab testing cadence influence payer claims timing, particularly for maintenance patients whose physician visits and lab monitoring create refill rhythms.
  • Competitive share changes affect both net sales growth rate and margin via rebates and access programs.

How does pricing and net-to-gross typically evolve in this category?

SZC pricing outcomes are governed by three recurring forces:

  1. Rebate intensification as penetration increases
    As a product moves from early access to broader managed care coverage, payer systems often demand larger rebates tied to utilization.

  2. Patient access program leverage
    Copay or assistance programs can sustain conversion from “eligible” to “treated,” but they can shift payer mix and affect net collections.

  3. Mix shift toward maintenance dosing
    Maintenance regimens generally increase total days of therapy, but dosing frequency and titration behavior alter the average patient daily dose, affecting realized revenue per treated patient.


What are the key demand-side indicators investors and operators track?

Even without full product financials in the provided dataset, these indicators reliably forecast revenue trajectory for SZC:

Prescribing and patient mix

  • Percent of patients on maintenance vs acute/initial-only dosing
  • Average daily dose and duration of therapy (titration patterns)
  • Persistence and refill cadence (discontinuation after stabilization is a common drag in chronic therapies)

Access

  • Formulary tier placement and uptake across national and regional payers
  • Prior authorization frequency and denial rates
  • Coverage for CKD vs heart failure subpopulations where clinical pathways overlap

Utilization

  • Claims volume trends as a proxy for treated patients
  • Geographic diffusion into health systems and large distributor networks

What are the major commercial risks and upside levers?

Risks

  • Competitive displacement if rival binders show better payer coverage or clinician preference in key subgroups
  • Maintenance underutilization if prescribers stabilize potassium and then stop therapy early
  • Reimbursement tightening if payer criteria become more restrictive for chronic use
  • Safety/tolerability perceptions that can influence adherence and dosing continuity

Upside levers

  • Guideline and pathway reinforcement that positions SZC earlier in the hyperkalemia course
  • Broader CKD and heart failure coverage that increases treatable addressable populations
  • Improved persistence through dosing protocols that reduce early drop-off after stabilization
  • Contract wins that improve net pricing stability

Competitive landscape: how share translates into revenue

SZC’s revenue trajectory is sensitive to competitive share because binders are close substitutes in practice patterns. Share changes transmit quickly into top-line because:

  • A patient treated with one binder can often switch if coverage changes or clinical outcomes shift.
  • Maintenance patients are “sticky,” so gaining early maintenance share can create compounding unit demand.
  • Payer-driven switching often targets cost, which means rebate and access negotiations are central to financial trajectory.

Key Takeaways

  • Sodium zirconium cyclosilicate (Lokelma) targets hyperkalemia with a commercial model that can scale through maintenance dosing, turning episodic labs into recurring therapy.
  • Market growth depends on formulary access, reimbursement behavior, and persistence, not only initial prescribing.
  • Financial trajectory is driven by volume (days of therapy), gross-to-net contracting, and mix shift toward maintenance dosing.
  • Product-level annual net sales cannot be stated from the information available in the provided request set; the actionable insight is that performance will track directly to access penetration and maintenance persistence rather than one-time uptake.

FAQs

  1. What drives demand for sodium zirconium cyclosilicate?
    Recurring treatment needs in CKD and heart failure populations where potassium-elevating regimens increase hyperkalemia risk, plus the ability to use SZC as maintenance after initial correction.

  2. Why does maintenance dosing matter financially?
    Maintenance increases days of therapy per patient and supports refill-based unit growth, shifting the revenue model from episodic to recurring.

  3. What is the biggest determinant of net revenue?
    Gross-to-net outcomes from payer rebates, formulary status, and utilization management tied to baseline potassium criteria and diagnoses.

  4. How does competition typically affect SZC’s market trajectory?
    Competitive switching and payer access changes can shift treated patient share quickly, especially for maintenance patients.

  5. Which KPIs best predict SZC revenue trend?
    Treated patient claims volume, persistence/refill cadence, percentage on maintenance dosing, and formulary access changes across major payers.


References

[1] FDA. “Lokelma (sodium zirconium cyclosilicate) prescribing information.” U.S. Food and Drug Administration.
[2] Takeda. “Lokelma (sodium zirconium cyclosilicate) product information and commercialization materials.” Takeda.
[3] KDIGO. “Clinical Practice Guidelines for the Management of Chronic Kidney Disease.” Kidney Disease: Improving Global Outcomes (KDIGO).
[4] European Society of Cardiology (ESC) and related guideline publications on hyperkalemia management.

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