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Last Updated: November 7, 2024

CILASTATIN SODIUM; IMIPENEM; RELEBACTAM - Generic Drug Details


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What are the generic drug sources for cilastatin sodium; imipenem; relebactam and what is the scope of freedom to operate?

Cilastatin sodium; imipenem; relebactam is the generic ingredient in one branded drug marketed by Msd Merck Co and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Cilastatin sodium; imipenem; relebactam has seventy-one patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM
International Patents:71
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 2
DailyMed Link:CILASTATIN SODIUM; IMIPENEM; RELEBACTAM at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM
Generic Entry Date for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INTRAVENOUS

*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 CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
M.D. Anderson Cancer CenterPhase 2
Merck Sharp & Dohme Corp.Phase 3

See all CILASTATIN SODIUM; IMIPENEM; RELEBACTAM clinical trials

Pharmacology for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

US Patents and Regulatory Information for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msd Merck Co RECARBRIO cilastatin sodium; imipenem; relebactam POWDER;INTRAVENOUS 212819-001 Jul 16, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msd Merck Co RECARBRIO cilastatin sodium; imipenem; relebactam POWDER;INTRAVENOUS 212819-001 Jul 16, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msd Merck Co RECARBRIO cilastatin sodium; imipenem; relebactam POWDER;INTRAVENOUS 212819-001 Jul 16, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

Country Patent Number Title Estimated Expiration
South Korea 101648728 ⤷  Sign Up
Israel 206395 N-הטרוציקליל-7-אוקסו-6-סולפאוקסי-6,1-דיאזאביציקלו[1.2.3]אוקטן-2-קרבוקסאמידים ותכשירים רוקחיים המכילים אותם (N-heterocyclyl-7-oxo-6-sulfooxy-1,6-diazabicyclo[3.2.1]octane-2-carboxamides and pharmaceutical compositions comprising them) ⤷  Sign Up
Serbia 53052 INHIBITORI BETA-LAKTAMAZE (BETA-LACTAMASE INHIBITORS) ⤷  Sign Up
China 101918407 Beta-lactamase inhibitors ⤷  Sign Up
Cyprus 2020024 ⤷  Sign Up
Spain 2433744 ⤷  Sign Up
Denmark 2666774 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2231667 20C1030 France ⤷  Sign Up PRODUCT NAME: RELEBACTAM OU UN MONOHYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/19/1420 20200217
2666774 CA 2020 00037 Denmark ⤷  Sign Up PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217
2231667 2020C/522 Belgium ⤷  Sign Up DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
2231667 CA 2020 00036 Denmark ⤷  Sign Up PRODUCT NAME: RELEBACTAM OR A MONOHYDRATE THEREOF; REG. NO/DATE: EU/1/19/1420 20200217
2666774 PA2020517,C2666774-1 Lithuania ⤷  Sign Up PRODUCT NAME: RELEBAKTAMAS, PASIRINKTINAI MONOHIDRATO PAVIDALU, IR IMIPENEMAS; REGISTRATION NO/DATE: EU/1/19/1420 20200213
2231667 C202030033 Spain ⤷  Sign Up PRODUCT NAME: RELEBACTAM O SU MONOHIDRATO; NATIONAL AUTHORISATION NUMBER: EU/1/19/1420; DATE OF AUTHORISATION: 20200213; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1420; DATE OF FIRST AUTHORISATION IN EEA: 20200213
2666774 301051 Netherlands ⤷  Sign Up DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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