Sodium zirconium cyclosilicate - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug 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 twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.Sodium zirconium cyclosilicate has one hundred and twenty-one patent family members in thirty-five countries.
One supplier is listed for this compound.
Summary for sodium zirconium cyclosilicate
| International Patents: | 121 |
| US Patents: | 12 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 26 |
| What excipients (inactive ingredients) are in sodium zirconium cyclosilicate? | sodium zirconium cyclosilicate excipients list |
| DailyMed Link: | sodium zirconium cyclosilicate at DailyMed |
Recent Clinical Trials for sodium zirconium cyclosilicate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| St George's, University of London | Phase 3 |
| Göteborg University | Phase 2 |
| Michael Fu | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for sodium zirconium cyclosilicate
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 | 207078-002 | May 18, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-002 | May 18, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-002 | May 18, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >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 | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-002 | May 18, 2018 | See Plans and Pricing | See Plans and Pricing |
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-001 | May 18, 2018 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for sodium zirconium cyclosilicate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 2016005940 | SILICATO DE ZIRCONIO MICROPOROSO PARA EL TRATAMIENTO DE LA HIPERPOTASEMIA. (MICROPOROUS ZIRCONIUM SILICATE FOR THE TREATMENT OF HYPERKALEMIA.) | See Plans and Pricing |
| Mexico | 341822 | SILICATO DE ZIRCONIO MICROPOROSO PARA EL TRATAMIENTO DE HIPERCALEMIA. (MICROPOROUS ZIRCONIUM SILICATE FOR THE TREATMENT OF HYPERKALEMIA.) | See Plans and Pricing |
| Hong Kong | 1211494 | 用於治療高鉀血症的微孔硅酸鋯 (MICROPOROUS ZIRCONIUM SILICATE FOR TREATING HYPERKALEMIA) | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sodium zirconium cyclosilicate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1259550 | 08C0052 | France | See Plans and Pricing | PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725 |
| 1666481 | 17C1031 | France | See Plans and Pricing | 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 |
| 2203431 | 2015/009 | Ireland | See Plans and Pricing | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
