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Last Updated: December 4, 2020

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LOKELMA Drug Profile

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When do Lokelma patents expire, and what generic alternatives are available?

Lokelma is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are twelve patents protecting this drug.

This drug has one hundred and thirteen patent family members in thirty-two 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. One supplier is listed for this compound. Additional details are available on the sodium zirconium cyclosilicate profile page.

US ANDA Litigation and Generic Entry Outlook for Lokelma

Lokelma will be eligible for patent challenges on May 18, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

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Summary for LOKELMA
International Patents:113
US Patents:12
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 2
Drug Prices: Drug price information for LOKELMA
DailyMed Link:LOKELMA at DailyMed
Drug patent expirations by year for LOKELMA
Drug Prices for LOKELMA

See drug prices for LOKELMA

Generic Entry Opportunity 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

SponsorPhase
University of California, IrvinePhase 4
AstraZenecaPhase 4
Zealand University HospitalPhase 4

See all LOKELMA clinical trials

US Patents and Regulatory Information for LOKELMA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-001 May 18, 2018 RX Yes No   Start Trial   Start Trial Y   Start Trial
Astrazeneca Pharms LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-002 May 18, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca Pharms LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-002 May 18, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca Pharms LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-001 May 18, 2018 RX Yes No   Start Trial   Start Trial Y   Start 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 LOKELMA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-002 May 18, 2018   Start Trial   Start Trial
Astrazeneca Pharms LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-001 May 18, 2018   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for LOKELMA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1856135 LUC00153 Luxembourg   Start Trial PRODUCT NAME: FOSTAMATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, OU UN HYDRATE, SOLVATE OU N-OXYDE DE FOSTAMATINIB OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, EN PARTICULIER FOSTAMATINIB DISODIUM, EVENTUELLEMENT SOUS FORME D'HYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113
1758590 LUC00029 Luxembourg   Start Trial PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
2673237 CA 2019 00014 Denmark   Start Trial PRODUCT NAME: NATRIUMZIRCONIUMCYCLOSILICAT; REG. NO/DATE: EU/1/17/1173 20180326
2932970 18C1043 France   Start Trial PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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.