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

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

Two suppliers are listed for this compound.

Summary for sodium zirconium cyclosilicate

International Patents:	122
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	27
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Michael Fu	Phase 2
St George's, University of London	Phase 3

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	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018	⤷ Sign Up	⤷ Sign Up
>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
China	106170283	用于治疗高钾血症的微孔硅酸锆 (Microporous zirconium silicate for the treatment of hyperkalemia)	⤷ Sign Up
China	104797263	Microporous zirconium silicate for treating hyperkalemia	⤷ Sign Up
Costa Rica	20180276	COMPOSICIONES DE SILICATO DE ZIRCONIO DE USO PROLONGADO Y MÉTODOS DE USO DE LAS MISMAS	⤷ Sign Up
Chile	2016001094	Silicato de zirconio microporoso para el tratamiento de hipercalemia.	⤷ Sign Up
Philippines	12015500849	MICROPOROUS ZIRCONIUM SILICATE FOR TREATING HYPERKALEMIA	⤷ Sign Up
Japan	2016535754		⤷ Sign Up
>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
0806968	SPC/GB07/011	United Kingdom	⤷ Sign Up	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
2380576	SPC/GB20/050	United Kingdom	⤷ Sign Up	PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526
1499331	13C0055	France	⤷ Sign Up	PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
0480717	SPC/GB98/025	United Kingdom	⤷ Sign Up	PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
1758590	LUC00029	Luxembourg	⤷ Sign Up	PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
2380576	20C1048	France	⤷ Sign Up	PRODUCT NAME: SEL DE SODIUM DE L'ACIDE DESOXYCHOLIQUE; NAT. REGISTRATION NO/DATE: NL46299 20180810; FIRST REGISTRATION: IS - IS/1/16/071/01 20160729
>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.