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Last Updated: February 26, 2024

LOKELMA Drug Patent Profile


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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 nineteen 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 has been one patent litigation case 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

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Drug patent expirations by year for LOKELMA
Drug Prices for LOKELMA

See drug prices for LOKELMA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LOKELMA
Generic Entry Date for LOKELMA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
NephroNet, Inc.Phase 4
Göteborg UniversityPhase 2
AstraZenecaPhase 2

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 and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LOKELMA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting LOKELMA

Extended use zirconium silicate compositions and methods of use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Extended use zirconium silicate compositions and methods of use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS

FDA Regulatory Exclusivity protecting LOKELMA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

ADDITIONAL INFORMATION ADDED TO THE LABELING REGARDING THE USE IN PATIENTS ON CHRONIC HEMODIALYSIS
Exclusivity Expiration: ⤷  Try a Trial

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 6369
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 16338753
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2018007189
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 00950
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 18000916
Estimated Expiration: ⤷  Try a Trial

China

Patent: 8137620
Estimated Expiration: ⤷  Try a Trial

Patent: 3143958
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 180276
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 5890
Estimated Expiration: ⤷  Try a Trial

Patent: 1890875
Estimated Expiration: ⤷  Try a Trial

Patent: 2091273
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 62456
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 54808
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8478
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 46700
Estimated Expiration: ⤷  Try a Trial

Patent: 18530596
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 7088
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 18004440
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 018500786
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1803095
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 180067614
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 42004
Estimated Expiration: ⤷  Try a Trial

Patent: 1717972
Estimated Expiration: ⤷  Try a Trial

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
Chile 2016001166 Silicato de zirconio microporoso para el tratamiento de la hipercalemia ⤷  Try a Trial
Turkey 201901002 ⤷  Try a Trial
Chile 2016001095 Silicato de zirconio microporoso para el tratamiento de hipercalemia. ⤷  Try a Trial
Argentina 098367 COMPUESTO DE SILICATO DE ZIRCONIO MICROPOROSO PARA EL TRATAMIENTO DE LA HIPERCALEMIA ⤷  Try a Trial
Canada 2891053 SILICATE DE ZIRCONIUM MICROPOREUX POUR LE TRAITEMENT DE L'HYPERKALIEMIE (MICROPOROUS ZIRCONIUM SILICATE FOR TREATING HYPERKALEMIA) ⤷  Try a Trial
South Korea 20140033007 MICROPOROUS ZIRCONIUM SILICATE FOR THE TREATMENT OF HYPERKALEMIA ⤷  Try a Trial
Taiwan 201607544 Microporous zirconium silicate for the treatment of hyperkalemia ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LOKELMA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2673237 LUC00111 Luxembourg ⤷  Try a Trial PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1173 20180326
3141251 301099 Netherlands ⤷  Try a Trial PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016
2673237 2019C/519 Belgium ⤷  Try a Trial PRODUCT NAME: LOKELMA - CYCLOSILICATE DE ZIRCONIUM SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/17/1173 20180326
0145340 99C0005 Belgium ⤷  Try a Trial PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
1874117 2014/032 Ireland ⤷  Try a Trial PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
0480717 98C0022 France ⤷  Try a Trial PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
0806968 SPC/GB07/011 United Kingdom ⤷  Try a Trial PRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Medtronic
AstraZeneca
Dow
Moodys
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.