LOKELMA Drug Patent Profile
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When do Lokelma patents expire, and what generic alternatives are available?
Lokelma is a drug marketed by Astrazeneca and is included in one NDA. There are fourteen patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and twenty-one patent family members in thirty-five countries.
The generic ingredient in LOKELMA is sodium zirconium cyclosilicate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium zirconium cyclosilicate profile page.
DrugPatentWatch® Generic Entry Outlook for Lokelma
Lokelma was eligible for patent challenges on May 18, 2022.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 14, 2035. This may change due to patent challenges or generic licensing.
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
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Questions you can ask:
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Summary for LOKELMA
| International Patents: | 121 |
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Clinical Trials: | 7 |
| Drug Prices: | Drug price information for LOKELMA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LOKELMA |
| What excipients (inactive ingredients) are in LOKELMA? | LOKELMA excipients list |
| DailyMed Link: | LOKELMA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LOKELMA
*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 LOKELMA
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 LOKELMA
| 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 LOKELMA
LOKELMA is protected by fourteen US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of LOKELMA is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting LOKELMA
Extended use zirconium silicate compositions and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Extended use zirconium silicate compositions and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-002 | May 18, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-002 | May 18, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-001 | May 18, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-001 | May 18, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 LOKELMA
| 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 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-002 | May 18, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for LOKELMA
| 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 LOKELMA
When does loss-of-exclusivity occur for LOKELMA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 6369
Patent: USO PROLONGADO DE COMPOSICIONES DE SILICATO DE CIRCONIO Y MÉTODOS PARA SU USO
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 16338753
Patent: Extended use zirconium silicate compositions and methods of use thereof
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2018007189
Patent: composições de silicato de zircônio para uso prolongado e métodos de uso dos mesmos
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 00950
Patent: COMPOSITIONS DE SILICATE DE ZIRCONIUM A USAGE PROLONGE ET PROCEDES D'UTILISATION CORRESPONDANTS (EXTENDED USE ZIRCONIUM SILICATE COMPOSITIONS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 18000916
Patent: Composiciones de silicato de zirconio de uso prolongado y métodos de uso de las mismas
Estimated Expiration: ⤷ Sign Up
China
Patent: 8137620
Patent: 扩大使用硅酸锆组合物及其使用方法 (EXTENDED USE ZIRCONIUM SILICATE COMPOSITIONS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 3143958
Patent: 扩大使用硅酸锆组合物及其使用方法 (Extended use zirconium silicate compositions and methods of use thereof)
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 180276
Patent: COMPOSICIONES DE SILICATO DE ZIRCONIO DE USO PROLONGADO Y MÉTODOS DE USO DE LAS MISMAS
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 5890
Patent: КОМПОЗИЦИИ НА ОСНОВЕ СИЛИКАТА ЦИРКОНИЯ ДЛЯ ЛЕЧЕНИЯ ГИПЕРКАЛИЕМИИ (ZIRCONIUM SILICATE COMPOSITIONS FOR TREATING HYPERKALEMIA)
Estimated Expiration: ⤷ Sign Up
Patent: 1890875
Patent: КОМПОЗИЦИИ НА ОСНОВЕ СИЛИКАТА ЦИРКОНИЯ ДЛЯ ДЛИТЕЛЬНОГО ПРИМЕНЕНИЯ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ
Estimated Expiration: ⤷ Sign Up
Patent: 2091273
Patent: КОМПОЗИЦИИ НА ОСНОВЕ СИЛИКАТА ЦИРКОНИЯ ДЛЯ ДЛИТЕЛЬНОГО ПРИМЕНЕНИЯ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 62456
Patent: COMPOSITIONS DE SILICATE DE ZIRCONIUM À USAGE PROLONGÉ ET PROCÉDÉS D'UTILISATION CORRESPONDANTS (EXTENDED USE ZIRCONIUM SILICATE COMPOSITIONS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 54808
Patent: 長期使用的硅酸鋯組合物及其使用方法 (EXTENDED USE ZIRCONIUM SILICATE COMPOSITIONS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 8478
Patent: שימוש מורחב בתרכובות זירקוניום סיליקוניות ושיטות לשימושן (Extended use zirconium silicate compositions and methods of use thereof)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 46700
Estimated Expiration: ⤷ Sign Up
Patent: 18530596
Patent: ケイ酸ジルコニウム組成物の長期間の使用及びその使用方法
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 7088
Patent: EXTENDED USE ZIRCONIUM SILICATE COMPOSITIONS AND METHODS OF USE THEREOF
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 18004440
Patent: COMPOSICIONES DE SILICATO DE ZIRCONIO DE USO PROLONGADO Y METODOS DE USO DE LAS MISMAS. (EXTENDED USE ZIRCONIUM SILICATE COMPOSITIONS AND METHODS OF USE THEREOF.)
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 018500786
Patent: EXTENDED USE ZIRCONIUM COMPOSITIONS AND METHODS OF USE THEREOF
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1803095
Patent: EXTENDED USE ZIRCONIUM SILICATE COMPOSITIONS AND METHODS OF USE THEREOF
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 180067614
Patent: 연장된 용도의 지르코늄 실리케이트 조성물 및 이의 사용 방법
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 42004
Estimated Expiration: ⤷ Sign Up
Patent: 1717972
Patent: Extended use zirconium silicate compositions and methods of use thereof
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering LOKELMA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 3246287 | SILICATE DE ZIRCONIUM MICROPOREUX POUR LE TRAITEMENT DE L'HYPERKALÉMIE (MICROPOROUS ZIRCONIUM SILICATE FOR THE TREATMENT OF HYPERKALEMIA) | ⤷ Sign Up |
| Australia | 2016338753 | Extended use zirconium silicate compositions and methods of use thereof | ⤷ Sign Up |
| Australia | 2016204124 | Microporous zirconium silicate for the treatment of hyperkalemia | ⤷ Sign Up |
| Philippines | 12016500861 | MICROPOROUS ZIRCONIUM SILICATE FOR THE TREATMENT OF HYPERKALEMIA | ⤷ Sign Up |
| Mexico | 354456 | SILICATO DE ZIRCONIO MICROPOROSO PARA EL TRATAMIENTO DE HIPERCALEMIA. (MICROPOROUS ZIRCONIUM SILICATE FOR THE TREATMENT OF HYPERKALEMIA.) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LOKELMA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1874117 | SPC/GB14/041 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121 |
| 0788511 | SPC/GB08/036 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425 |
| 1499331 | SPC/GB13/034 | United Kingdom | ⤷ Sign Up | 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 |
| 3347352 | 2290051-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; REG. NO/DATE: EU/1/22/1671 20220819 |
| 1175904 | 2007C/048 | Belgium | ⤷ Sign Up | PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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