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 | 207078-002 | May 18, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 | 207078-001 | May 18, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-002 | 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 |
|---|---|---|---|
| Colombia | 6801733 | Silicato de zirconio microporoso para el tratamiento de la hipercalemia | ⤷ Try a Trial |
| South Korea | 20140033007 | MICROPOROUS ZIRCONIUM SILICATE FOR THE TREATMENT OF HYPERKALEMIA | ⤷ Try a Trial |
| Argentina | 098367 | COMPUESTO DE SILICATO DE ZIRCONIO MICROPOROSO PARA EL TRATAMIENTO DE LA HIPERCALEMIA | ⤷ 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 |
|---|---|---|---|---|
| 2673237 | 2019C/519 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LOKELMA - CYCLOSILICATE DE ZIRCONIUM SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/17/1173 20180326 |
| 3141251 | 301099 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
