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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 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 eight patent family members in thirty-one 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: | 108 |
| US Patents: | 12 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1472 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 12 |
| DailyMed Link: | sodium zirconium cyclosilicate at DailyMed |
Recent Clinical Trials for sodium zirconium cyclosilicate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Steno Diabetes Center Copenhagen | Phase 4 |
| AstraZeneca | Phase 4 |
| Zealand University Hospital | Phase 4 |
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 | 207078-002 | 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 | 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 | Y | 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2017251722 | Start Trial |
| Mexico | 2016005940 | Start Trial |
| Canada | 2929978 | Start Trial |
| Argentina | 098367 | Start Trial |
| Spain | 2709004 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for sodium zirconium cyclosilicate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2673237 | PA2019010 | Lithuania | Start Trial | PRODUCT NAME: CIRKONIO CIKLOSILIKATO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/17/1173/001-004 20180322 |
| 2932970 | 1890039-9 | Sweden | Start Trial | PRODUCT NAME: DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE; REG. NO/DATE: EU/1/18/1282 20180518 |
| 1912999 | 14C0076 | France | Start Trial | PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140516 |
| 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 |
| 2203431 | 92666 | Luxembourg | Start Trial | PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
