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 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
Generic Entry Date for SODIUM ZIRCONIUM CYCLOSILICATE*:
Constraining patent/regulatory exclusivity:
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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-002 | May 18, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-001 | May 18, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-002 | May 18, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-002 | May 18, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-001 | May 18, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-002 | May 18, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-001 | May 18, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| China | 104797263 | Microporous zirconium silicate for treating hyperkalemia | ⤷ Try a Trial |
| Costa Rica | 20180276 | COMPOSICIONES DE SILICATO DE ZIRCONIO DE USO PROLONGADO Y MÉTODOS DE USO DE LAS MISMAS | ⤷ Try a Trial |
| South Korea | 20160073424 | 고칼륨혈증의 치료를 위한 미세다공성 규산지르코늄 (MICROPOROUS ZIRCONIUM SILICATE FOR THE TREATMENT OF HYPERKALEMIA) | ⤷ Try a Trial |
| Australia | 2016204124 | Microporous zirconium silicate for the treatment of hyperkalemia | ⤷ Try a Trial |
| Hong Kong | 1211494 | 用於治療高鉀血症的微孔硅酸鋯 (MICROPOROUS ZIRCONIUM SILICATE FOR TREATING HYPERKALEMIA) | ⤷ Try a Trial |
| China | 108969535 | 用于治疗高钾血症的微孔性的硅酸锆 (Microporous zirconium silicate for the treatment of hyperkalemia) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SODIUM ZIRCONIUM CYCLOSILICATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0806968 | SPC/GB07/011 | United Kingdom | ⤷ Try a 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 | SPC/GB13/034 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313 |
| 2673237 | CA 2019 00014 | Denmark | ⤷ Try a Trial | PRODUCT NAME: NATRIUMZIRCONIUMCYCLOSILICAT; REG. NO/DATE: EU/1/17/1173 20180326 |
| 2822954 | 2018/031 | Ireland | ⤷ Try a Trial | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTRATION NO/DATE: EU/1/18/1289 20180625 |
| 1856135 | 2090014-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE OR SOLVATE OF FOSTAMATINIB OR THE PH ARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113 |
| 2203431 | 1590018-6 | Sweden | ⤷ Try a Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
