SODIUM ZIRCONIUM CYCLOSILICATE - Generic Drug Details

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 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

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

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	207078-001	May 18, 2018		RX	Yes	No				Y
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No				Y
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018		RX	Yes	Yes				Y
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No				Y

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
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018

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

International Patents for SODIUM ZIRCONIUM CYCLOSILICATE

Country	Patent Number	Title	Estimated Expiration
Denmark	2673237
Australia	2012214224	Microporous zirconium silicate for the treatment of hyperkalemia
Japan	2016535754	高カリウム血症治療用細孔性ケイ酸ジルコニウム
China	109106725	用于治疗高钾血症的微孔性的硅酸锆 (MICROPOROUS ZIRCONIUM SILICATE FOR THE TREATMENT OF HYPERKALEMIA)
Australia	2013334776	Microporous zirconium silicate for treating hyperkalemia
European Patent Office	2882444	SILICATE DE ZIRCONIUM MICROPOREUX POUR LE TRAITEMENT DE L'HYPERKALIÉMIE (MICROPOROUS ZIRCONIUM SILICATE FOR TREATING HYPERKALEMIA)

Supplementary Protection Certificates for SODIUM ZIRCONIUM CYCLOSILICATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822954	18C1035	France		PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
0957929	SPC/GB06/021	United Kingdom		PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201
2673237	122019000036	Germany		PRODUCT NAME: NATRIUMZIRCONIUMCYCLOSILICAT; REGISTRATION NO/DATE: EU/1/17/1173 20180322
1713823	1490064-1	Sweden		PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
2340828	LUC00195	Luxembourg		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
1758590	2017C/063	Belgium		PRODUCT NAME: SEL DE SODIUM D'ACIDE DESOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: SE/H/1547/01/DC 20170612