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 six 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
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	8
Patent Applications:	8
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

Constraining patent/regulatory exclusivity:

8,877,255

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
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.

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
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No	10,398,730
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No	8,802,152			Y

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	6,332,985
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018	6,332,985

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

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
Argentina	106369
Australia	2016338753
Brazil	112018007189
Canada	3000950
Chile	2018000916
China	108137620

Supplementary Protection Certificates for LOKELMA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0957929	06C0021	France		PRODUCT NAME: PEGAPTANIB SODIUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131
0788511	SPC/GB08/036	United Kingdom		PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
1713823	1490064-1	Sweden		PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
0473687	SPC/GB98/030	United Kingdom		PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
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

Last updated: July 20, 2026

kelma (sodium zirconium cyclosilicate) Market Dynamics and Financial Trajectory (2020–2026)
Lokelma has built share in US hyperkalemia treatment by pairing rapid onset with broad payer acceptance. Growth has been driven by formulary placement in CKD and heart failure populations and by scaling in hospital and outpatient settings. The financial trajectory since launch reflects: (1) steady uptake after initial ramp, (2) pricing and channel dynamics shaped by payer contracting, (3) competitive pressure from patiromer and, to a lesser extent, sodium polystyrene sulfonate (SPS) products, and (4) increasing regulatory familiarity with chronic hyperkalemia management.

How has Lokelma’s market share evolved vs patiromer and SPS?

Answer: Lokelma has gained share in non-emergent hyperkalemia management and has also penetrated acute settings, leveraging faster potassium reduction than patiromer and a dosing profile designed for both initiation and maintenance.

What competitive choices do payers and clinicians compare?

Clinicians and pharmacy committees usually compare Lokelma against:

• Patiromer (Veltassa) for chronic hyperkalemia prevention
• Sodium polystyrene sulfonate (SPS) generics and branded products for potassium lowering, typically with more GI tolerability tradeoffs
• Insulin/dextrose, albuterol, dialysis protocols for acute emergencies (not direct oral chronic comparators)

Lokelma vs patiromer: what drives the substitution rate?

Key differentiators that support switching:

• Speed of potassium reduction (Lokelma is used in settings where faster onset matters)
• Titration and maintenance strategies
• Tolerability profile (GI events patterns differ across classes)

Market implication: When formularies are updated, committees weigh not only outcomes and adverse events, but also patient adherence, timing convenience, and practical switching from existing potassium binders.

What role do hospital formularies play?

Hospital adoption tends to accelerate after:

• Protocolization for acute and subacute hyperkalemia
• Demonstrated usability in emergency department and inpatient nephrology pathways
• Pharmacy-driven preference for consistent dosing and monitoring workflows

How does chronic CKD and heart failure expand use?

The chronic hyperkalemia population grows with:

• Increased RAAS inhibitor and MRA use
• More routine potassium monitoring in CKD and HF management
• Clinical pathways that treat hyperkalemia as a controllable chronic risk

What is the revenue trajectory for Lokelma since launch, and what segment mix matters most?

Answer: Lokelma’s trajectory is characterized by a ramp post-launch, followed by continued expansion tied to outpatient chronic use. Growth tends to outperform initially when payer coverage broadens and clinical pathways stabilize.

Revenue drivers by channel

For sodium zirconium cyclosilicate, the business drivers typically include:

• Outpatient specialty and chronic kidney disease clinics: long-term continuity
• Hospital outpatient and infusion centers: higher-volume episodic use
• Inpatient: acute potassium management protocols
• Retail pharmacy: payer-covered maintenance dosing regimens

What does pricing and contracting do to net sales?

Net sales outcomes depend on:

• Rebates tied to formulary position
• Contracting strategy with large pharmacy benefit managers and integrated delivery networks
• Patient copay management that influences persistence

How do dosage and dosing frequency affect unit economics?

Lokelma’s commercial model is sensitive to:

• Use of initiation regimens versus maintenance dosing
• Patient adherence patterns and titration intensity
• Real-world persistence, especially in CKD and HF where therapy is long duration

When does Lokelma face major financial inflection from competition or coverage changes?

Answer: The next major financial inflection points for Lokelma are typically payer-driven and competition-driven: formulary status changes and new entrants to hyperkalemia chronic management.

What competition catalysts matter next?

Competition catalysts usually come from:

• Increased penetration by patiromer through formulary expansions
• SPS adoption tied to cost-sensitive payer strategies
• Any new hyperkalemia agents with differentiation around onset, tolerability, or dosing

What is the risk from generic sodium polystyrene sulfonate?

SPS generics can pressure pricing in low-margin segments. Their uptake depends on:

• Clinician confidence in outcomes and safety
• Institutional tolerance for GI adverse events management
• Payer emphasis on lowest acquisition cost

What is the risk from payer step therapy?

Step therapy can slow adoption if payers require trial of alternatives before covering Lokelma. Revenue impact can appear with:

• Formulary committee changes
• PBM utilization management updates
• Changes in prior authorization criteria

How strong is Lokelma’s patent estate for protecting revenue through 2030 and beyond?

Answer: Lokelma’s exclusivity and patent protection are anchored in compositions of matter and additional patent families related to formulation, methods, and specific uses. This creates a multi-layer barrier to direct generic entry.

What patent families typically protect zirconium cyclosilicate products?

Common patent coverage clusters for this category include:

• Composition of matter for the active zirconium cyclosilicate
• Particle size and solid state properties (crystal or framework characteristics)
• Formulation patents (dosage form and excipients)
• Method-of-use patents for hyperkalemia treatment and maintenance
• Process and manufacturing patents

What litigation pattern tends to apply to this type of product?

For oral systemically absorbed binders, generic entry efforts typically focus on:

• Challenging composition or formulation patents
• Attempting around specific particle/solid-state claims
• Pursuing non-infringing manufacturing routes

What is the Orange Book status of Lokelma, and how many patents are listed?

Answer: Lokelma is listed in the FDA Orange Book for the relevant drug product(s), with multiple patents typically spanning drug substance, formulation, and methods.

What to check in the Orange Book

Key entries for business planning include:

• Patent numbers and listed claim types (drug substance, formulation, method)
• Expiration dates and any listed exclusivity blocks
• Whether there are active “paragraph IV” settlement events affecting launch timing

What generic entry risks exist for Lokelma, and what would a launch timeline look like?

Answer: The primary generic risk is tied to the expiration of the latest blocking patents listed in the Orange Book plus any exclusivity periods. The commercial launch timeline would depend on:

• Whether challengers file Abbreviated New Drug Applications early
• Whether patent litigation leads to launch-at-risk or delayed launch
• Whether a settlement agreement imposes an agreed entry date

How does litigation timing translate to market disruption?

A typical disruption path is:

• Paragraph IV filing date becomes a proxy for probable launch window
• District court rulings can accelerate or delay entry
• Settlement agreements create a hard calendar constraint for generic competition

How does Lokelma’s clinical profile translate into payer coverage and uptake?

Answer: Lokelma’s clinical profile supports payer confidence in chronic hyperkalemia management, especially for CKD and HF patients who need ongoing RAAS inhibitor therapy.

What endpoints drive formulary placement?

Payers generally map coverage to:

• Potassium reduction effectiveness and speed
• Maintenance control and reduced recurrence
• Safety and tolerability
• Monitoring burden and practical clinical workflow

What evidence patterns tend to increase adoption?

Evidence that supports broader coverage includes:

• Subgroup results in CKD and HF
• Real-world adherence and persistence observations
• Improved ability to continue RAAS inhibitor therapy in hyperkalemia-prone populations

How does Lokelma compare with Veltassa on adoption economics and outcomes?

Answer: Lokelma’s adoption economics are influenced by its faster potassium reduction profile and dosing flexibility, which can increase clinician preference and reduce time-to-control in acute or early intervention pathways.

Where does Veltassa still win?

Veltassa may retain strength where:

• Institutional workflows are optimized around patiromer
• Payer contracts favor it
• Clinician familiarity and patient history favor continuation

Where does Lokelma gain share?

Lokelma tends to gain where:

• Formulary committees permit rapid transition
• Care pathways emphasize timely potassium reduction
• Patient persistence favors the specific dosing and monitoring routine

What manufacturing and supply chain factors could affect Lokelma’s financial performance?

Answer: For solid oral binders, supply stability and consistency of product quality are critical to prevent shortages, contract penalties, and rebids tied to service levels.

What operational issues usually matter most?

• Bulk API or intermediate availability
• Finished dosage form fill-finish capacity
• Quality system stability and batch release timelines
• Distributor allocation and cold logistics are typically not key for this product class, but distribution reliability still affects fulfillment

Which companies profit most from Lokelma’s value chain?

Answer: Lokelma’s commercial value is concentrated in the product’s marketer and in upstream suppliers supporting zirconium cyclosilicate manufacturing.

Key business roles

• Marketing authorization holder and commercial payer contracting
• Specialty and hospital channel sales organizations
• Manufacturing and quality responsible parties for finished dosage

Key Takeaways

• Lokelma’s market dynamics have been defined by adoption in chronic hyperkalemia management, especially CKD and heart failure populations.
• Competitive pressure is dominated by patiromer and cost competition from SPS, with payer coverage and step therapy decisions acting as the highest-leverage levers.
• Financial trajectory is primarily driven by outpatient persistence, net pricing through contracting, and hospital protocolization that expands early control and maintenance adherence.
• Generic entry risk depends on the latest Orange Book blocking patents and exclusivity blocks; litigation and settlement timing determine the calendar for market disruption.
• Patent estate strength and Orange Book listings are the gating variables for long-range financial planning through the late 2020s and beyond.

FAQs

1. What drives Lokelma formulary inclusion in CKD and heart failure?
2. How do step therapy and prior authorization rules affect Lokelma net sales growth?
3. What is the practical difference in dosing strategy between Lokelma initiation and maintenance regimens?
4. What Orange Book patent types most commonly block generic substitution for sodium zirconium cyclosilicate?
5. How does hospital inpatient protocol adoption change utilization patterns for Lokelma vs patiromer?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Labeling and prescribing information for Lokelma (sodium zirconium cyclosilicate). U.S. Food and Drug Administration.
3. Annual reports and investor presentations for Lokelma’s marketer and relevant competitor drug manufacturers (Veltassa and SPS business updates).

DrugChatter Q&A for LOKELMA

When was lokelma approved?
When does lokelma loose patent?
Lokelma when will there be a generic version?
Data expira patente de lokelma brasil?
When does lokelma become generic?