Sodium zirconium cyclosilicate - Generic Drug Details
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What are the generic 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 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 |
| St George's, University of London | Phase 3 |
| Göteborg University | Phase 2 |
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 | ⤷ 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 | 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 | ||||
| >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 |
|---|---|---|---|
| Chile | 2018000916 | Composiciones de silicato de zirconio de uso prolongado y métodos de uso de las mismas | ⤷ Try a Trial |
| Chile | 2013002337 | Una composicion de intercambio de cationes que comprende silicato de zirconio; producto farmaceutico; metodo de tratamiento de hipercalemia; metodo de elaboracion de la composicion, composicion de silicato de zirconio microporoso; reactor; y metodo de preparacion de la composicion dentro del reactor. | ⤷ Try a Trial |
| China | 106170283 | 用于治疗高钾血症的微孔硅酸锆 (Microporous zirconium silicate for the treatment of hyperkalemia) | ⤷ Try a Trial |
| Australia | 2014346572 | 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 |
|---|---|---|---|---|
| 0268956 | SPC/GB98/040 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508 |
| 2673237 | 300976 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: NATRIUMZIRKONIUMCYCLOSILICAAT; REGISTRATION NO/DATE: EU/1/17/1173 20180326 |
| 2932970 | SPC/GB18/041 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518 |
| 2673237 | PA2019010 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: CIRKONIO CIKLOSILIKATO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/17/1173/001-004 20180322 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
