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Last Updated: December 3, 2022

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 thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sodium zirconium cyclosilicate has one hundred and twenty-one patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for sodium zirconium cyclosilicate
Recent Clinical Trials for sodium zirconium cyclosilicate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
NephroNet, Inc.Phase 4
St George's, University of LondonPhase 3
Göteborg UniversityPhase 2

See all sodium zirconium cyclosilicate clinical trials

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 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 207078-002 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 Y 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 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 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 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for sodium zirconium cyclosilicate

Country Patent Number Title Estimated Expiration
Argentina 098365 SILICATO DE ZIRCONIO MICROPOROSO PARA EL TRATAMIENTO DE LA HIPERCALEMIA See Plans and Pricing
Canada 2929956 SILICATE DE ZIRCONIUM MICROPOREUX POUR LE TRAITEMENT DE L'HYPERKALIEMIE (MICROPOROUS ZIRCONIUM SILICATE FOR THE TREATMENT OF HYPERKALEMIA) See Plans and Pricing
Australia 2014346576 Microporous zirconium silicate for the treatment of hyperkalemia See Plans and Pricing
World Intellectual Property Organization (WIPO) 2017066128 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2014066407 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sodium zirconium cyclosilicate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2563920 CR 2019 00001 Denmark See Plans and Pricing PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
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
1948158 93075 Luxembourg See Plans and Pricing PRODUCT NAME: SACUBITRIL ET 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-(PENTANYOL(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE) DE TRISODIUM HEMIPENTAHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
0473687 SPC/GB98/030 United Kingdom See Plans and Pricing PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
0957929 SPC/GB06/021 United Kingdom See Plans and Pricing PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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