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 freedom to operate?

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
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	⤷ 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	207078-002	May 18, 2018		RX	Yes	Yes	⤷ 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	207078-001	May 18, 2018	⤷ Sign Up	⤷ Sign Up
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	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
Turkey	201901002		⤷ Sign Up
Japan	2016505510		⤷ Sign Up
Taiwan	201607543	Microporous zirconium silicate for the treatment of hyperkalemia	⤷ Sign Up
South Africa	201306240	MICROPOROUS ZIRCONIUM SILICATE THE TREATMENT OF HYPERKALEMIA	⤷ 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
1912999	1490062-5	Sweden	⤷ Sign Up	PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
2822954	18C1035	France	⤷ Sign Up	PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
2822954	LUC00083	Luxembourg	⤷ Sign Up	PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625
2822954	SPC/GB18/031	United Kingdom	⤷ Sign Up	PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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