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Last Updated: January 20, 2020

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LOKELMA Drug Profile

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Which patents cover Lokelma, 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 eight patent family members in thirty-one 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

  Start Trial

Lokelma will be eligible for patent challenges on May 18th, 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 14th, 2035. This may change due to patent challenges or generic licensing.

Summary for LOKELMA
International Patents:108
US Patents:12
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 1
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
AstraZenecaPhase 4
Zealand University HospitalPhase 4
Steno Diabetes Center CopenhagenPhase 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   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   Start Trial
Astrazeneca Pharms LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-001 May 18, 2018 RX Yes No   Start Trial   Start Trial   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 207078-001 May 18, 2018   Start Trial   Start Trial
Astrazeneca Pharms LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-002 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
1666481 17C1031 France   Start Trial PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
2673237 PA2019010 Lithuania   Start Trial PRODUCT NAME: CIRKONIO CIKLOSILIKATO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/17/1173/001-004 20180322
0186405 SPC/GB00/021 United Kingdom   Start 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
2203431 CR 2015 00014 Denmark   Start Trial PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
2203431 92666 Luxembourg   Start Trial PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

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Moodys
Medtronic

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