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Last Updated: September 27, 2022

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 twelve patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-one 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. One supplier is 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for LOKELMA
International Patents:121
US Patents:12
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 6
Patent Applications: 44
Drug Prices: Drug price information for LOKELMA
What excipients (inactive ingredients) are in LOKELMA?LOKELMA excipients list
DailyMed Link:LOKELMA at DailyMed
Drug patent expirations by year for LOKELMA
Drug Prices for LOKELMA

See drug prices for LOKELMA

DrugPatentWatch® Estimated Generic Entry Opportunity 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
AstraZenecaPhase 2
Michael FuPhase 2
St George's, University of LondonPhase 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 twelve US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LOKELMA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Extended use zirconium silicate compositions and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS

Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS

FDA Regulatory Exclusivity protecting LOKELMA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

ADDITIONAL INFORMATION ADDED TO THE LABELING REGARDING THE USE IN PATIENTS ON CHRONIC HEMODIALYSIS
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-002 May 18, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-002 May 18, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-001 May 18, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-001 May 18, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-001 May 18, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-002 May 18, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Astrazeneca LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-002 May 18, 2018 See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 16338753
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2018007189
Estimated Expiration: See Plans and Pricing

Canada

Patent: 00950
Estimated Expiration: See Plans and Pricing

Chile

Patent: 18000916
Estimated Expiration: See Plans and Pricing

China

Patent: 8137620
Estimated Expiration: See Plans and Pricing

Patent: 3143958
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 180276
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 5890
Estimated Expiration: See Plans and Pricing

Patent: 1890875
Estimated Expiration: See Plans and Pricing

Patent: 2091273
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 62456
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 54808
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8478
Estimated Expiration: See Plans and Pricing

Japan

Patent: 46700
Estimated Expiration: See Plans and Pricing

Patent: 18530596
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 7088
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 18004440
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 018500786
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1803095
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 180067614
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 42004
Estimated Expiration: See Plans and Pricing

Patent: 1717972
Estimated Expiration: See Plans and Pricing

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
Japan 6071906 See Plans and Pricing
Slovenia 2673237 See Plans and Pricing
Taiwan 201607544 Microporous zirconium silicate for the treatment of hyperkalemia See Plans and Pricing
South Korea 20180067614 연장된 용도의 지르코늄 실리케이트 조성물 및 이의 사용 방법 See Plans and Pricing
Philippines 12018500786 EXTENDED USE ZIRCONIUM COMPOSITIONS AND METHODS OF USE THEREOF See Plans and Pricing
Montenegro 03294 PRIMENA CIRKONIJUM SILIKATA ZA TRETMAN HIPERKALEMIJE (USE OF A ZIRCONIUM SILICATE FOR THE TREATMENT OF HYPERKALEMIA) See Plans and Pricing
European Patent Office 3065709 SILICATE DE ZIRCONIUM MICROPOREUX POUR LE TRAITEMENT DE L'HYPERKALIÉMIE (MICROPOROUS ZIRCONIUM SILICATE FOR THE TREATMENT OF HYPERKALEMIA) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LOKELMA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2340828 LUC00195 Luxembourg See Plans and Pricing PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE DE SEL DE SODIUM SACUBITRIL VALSARTAN, C'EST-A-DIRE (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)-BIPHENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-ESTER ETHYLIQUE D'ACIDE PENTANOIQUE))NA3 X H2O, DANS LEQUEL X EST 0 A 3; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
2203431 1590018-6 Sweden See Plans and Pricing PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
2203431 CR 2015 00014 Denmark See Plans and Pricing PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
0788511 SPC/GB08/036 United Kingdom See Plans and Pricing 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
2932970 SPC/GB18/041 United Kingdom See Plans and Pricing PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518
2822954 18C1035 France See Plans and Pricing PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
1912999 2014/058 Ireland See Plans and Pricing PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
>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.