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Last Updated: April 28, 2024

Sodium zirconium cyclosilicate - Generic Drug Details

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What are the generic drug 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 twenty patent family members in thirty-five countries.

Two suppliers are listed for this compound.

Summary for sodium zirconium cyclosilicate

International Patents:	120
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	27
Patent Applications:	38
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sodium zirconium cyclosilicate
What excipients (inactive ingredients) are in sodium zirconium cyclosilicate?	sodium zirconium cyclosilicate excipients list
DailyMed Link:	sodium zirconium cyclosilicate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for sodium zirconium cyclosilicate

Generic Entry Date for sodium zirconium cyclosilicate^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

Sponsor	Phase
NephroNet, Inc.	Phase 4
St George's, University of London	Phase 3
Göteborg University	Phase 2

See all sodium zirconium cyclosilicate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for sodium zirconium cyclosilicate

V03AE	Drugs for treatment of hyperkalemia and hyperphosphatemia
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

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

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Glossary

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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	⤷ 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
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	207078-002	May 18, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ 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 sodium zirconium cyclosilicate

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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	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	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 sodium zirconium cyclosilicate

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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

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Country	Patent Number	Title	Estimated Expiration
Brazil	112018007189	composições de silicato de zircônio para uso prolongado e métodos de uso dos mesmos	⤷ Try a Trial
European Patent Office	3246287	SILICATE DE ZIRCONIUM MICROPOREUX POUR LE TRAITEMENT DE L'HYPERKALÉMIE (MICROPOROUS ZIRCONIUM SILICATE FOR THE TREATMENT OF HYPERKALEMIA)	⤷ Try a Trial
Eurasian Patent Organization	202091273	КОМПОЗИЦИИ НА ОСНОВЕ СИЛИКАТА ЦИРКОНИЯ ДЛЯ ДЛИТЕЛЬНОГО ПРИМЕНЕНИЯ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ	⤷ Try a Trial
Philippines	12015500849	MICROPOROUS ZIRCONIUM SILICATE FOR TREATING HYPERKALEMIA	⤷ Try a Trial
Turkey	201901002		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for sodium zirconium cyclosilicate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1713823	1490064-1	Sweden	⤷ Try a Trial	PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
0473687	SPC/GB98/030	United Kingdom	⤷ Try a Trial	PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
2673237	132019000000063	Italy	⤷ Try a Trial	PRODUCT NAME: CICLOSILICATO DI SODIO E ZIRCONIO(LOKELMA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1173, 20180326
2203431	CA 2015 00014	Denmark	⤷ Try a Trial	PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
2673237	1990016-6	Sweden	⤷ Try a Trial	PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; REG. NO/DATE: EU/1/17/1173 20180326
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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.