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Last Updated: December 14, 2019

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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 Pharms and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are one thousand four hundred and seventy-two drug master file entries for sodium zirconium cyclosilicate. One supplier is listed for this compound.

Summary for sodium zirconium cyclosilicate
International Patents:105
US Patents:12
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1472
Suppliers / Packagers: 1
Bulk Api Vendors: 1
Clinical Trials: 11
Patent Applications: 1
DailyMed Link:sodium zirconium cyclosilicate at DailyMed
Recent Clinical Trials for sodium zirconium cyclosilicate

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

SponsorPhase
AstraZenecaPhase 4
Zealand University HospitalPhase 4
Steno Diabetes Center CopenhagenPhase 4

See all sodium zirconium cyclosilicate clinical trials

Synonyms for sodium zirconium cyclosilicate
17141-74-1
CBTCHTJSGLCFMY-UHFFFAOYSA-N
Sodium zirconium silicate (Na2ZrSi3O9)
UZSi 9
UZSi-9
ZS 9
ZS-9 compound

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-001 May 18, 2018   Start Trial   Start Trial
Astrazeneca Pharms LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-002 May 18, 2018   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for sodium zirconium cyclosilicate

Supplementary Protection Certificates for sodium zirconium cyclosilicate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0806968 SPC/GB07/011 United Kingdom   Start Trial 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
1499331 13C0055 France   Start Trial PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
0480717 SPC/GB98/025 United Kingdom   Start Trial 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   Start Trial PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
2203431 15C0013 France   Start Trial PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
1666481 17C1031 France   Start Trial PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
1259550 08C0052 France   Start Trial PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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Dow

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