LOKELMA Drug Patent Profile
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When do Lokelma patents expire, and when can generic versions of Lokelma launch?
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 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
Summary for LOKELMA
International Patents: | 120 |
US Patents: | 14 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 2 |
Clinical Trials: | 7 |
Patent Applications: | 13 |
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 |
![LOKELMA drug patent expirations Drug patent expirations by year for LOKELMA](/p/graph/s/t/LOKELMA-patent-expirations.png)
![Drug Prices for LOKELMA](/p/graph/drug-price/LOKELMA.png)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LOKELMA
Generic Entry Date for LOKELMA*:
Constraining patent/regulatory exclusivity:
NDA:
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 LOKELMA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
NephroNet, Inc. | Phase 4 |
AstraZeneca | Phase 2 |
Michael Fu | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for LOKELMA
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Extended use zirconium silicate compositions and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS
Microporous zirconium silicate for the treatment of hyperkalemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA IN ADULTS
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 | ⤷ 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 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
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 16338753
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2018007189
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 00950
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 18000916
Estimated Expiration: ⤷ Try a Trial
China
Patent: 8137620
Estimated Expiration: ⤷ Try a Trial
Patent: 3143958
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 180276
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 5890
Estimated Expiration: ⤷ Try a Trial
Patent: 1890875
Estimated Expiration: ⤷ Try a Trial
Patent: 2091273
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 62456
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 54808
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 8478
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 46700
Estimated Expiration: ⤷ Try a Trial
Patent: 18530596
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 7088
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 18004440
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 018500786
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1803095
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 180067614
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 42004
Estimated Expiration: ⤷ Try a Trial
Patent: 1717972
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Eurasian Patent Organization | 201890875 | КОМПОЗИЦИИ НА ОСНОВЕ СИЛИКАТА ЦИРКОНИЯ ДЛЯ ДЛИТЕЛЬНОГО ПРИМЕНЕНИЯ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ | ⤷ Try a Trial |
South Korea | 20160110356 | 고칼륨혈증의 치료를 위한 미세다공성 규산지르코늄 (MICROPOROUS ZIRCONIUM SILICATE FOR THE TREATMENT OF HYPERKALEMIA) | ⤷ Try a Trial |
Cyprus | 1121310 | ⤷ Try a Trial | |
Australia | 2012214224 | Microporous zirconium silicate for the treatment of hyperkalemia | ⤷ Try a Trial |
Taiwan | 201607544 | Microporous zirconium silicate for the treatment of hyperkalemia | ⤷ Try a Trial |
Philippines | 12018500786 | EXTENDED USE ZIRCONIUM COMPOSITIONS AND METHODS OF USE THEREOF | ⤷ Try a Trial |
Mexico | 360684 | SILICATO DE ZIRCONIO MICROPOROSO PARA EL TRATAMIENTO DE LA HIPERCALEMIA. (MICROPOROUS ZIRCONIUM SILICATE FOR TREATING HYPERKALEMIA.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LOKELMA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0579826 | SPC/GB02/042 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422 |
2822954 | 1890030-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625 |
0957929 | SPC/GB06/021 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201 |
2673237 | C201930028 | Spain | ⤷ Try a Trial | PRODUCT NAME: CICLOSILICATO DE SODIO Y ZIRCONIO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1173; DATE OF AUTHORISATION: 20180322; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1173; DATE OF FIRST AUTHORISATION IN EEA: 20180322 |
1874117 | 2014/032 | Ireland | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121 |
2673237 | 19C1026 | France | ⤷ Try a Trial | PRODUCT NAME: CYCLOSILICATE DE ZIRCONIUM SODIQUE; NAT. REGISTRATION NO/DATE: EU/1/17/1173 20180326; FIRST REGISTRATION: - EU/1/17/1173 20180326 |
0186405 | SPC/GB00/021 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |