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Last Updated: June 26, 2022

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 sixty-four patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for cilastatin sodium; imipenem; relebactam
International Patents:64
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
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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Msd Merck Co RECARBRIO cilastatin sodium; imipenem; relebactam POWDER;INTRAVENOUS 212819-001 Jul 16, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msd Merck Co RECARBRIO cilastatin sodium; imipenem; relebactam POWDER;INTRAVENOUS 212819-001 Jul 16, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Japan 2012214475 β-LACTAMASE INHIBITOR See Plans and Pricing
Lithuania PA2020517 See Plans and Pricing
South Africa 201005333 BETA-LACTAMASE INHIBITORS See Plans and Pricing
Lithuania PA2020518 See Plans and Pricing
South Korea 101648728 See Plans and Pricing
New Zealand 586861 Nitrogen-containing bridged ring compounds as beta-lactamase inhibitors See Plans and Pricing
>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
2666774 C202030035 Spain See Plans and Pricing PRODUCT NAME: RELEBACTAM, OPCIONALMENTE EN FORMA DE MONOHIDRATO E IMIPENEM Y CILASTATINA; 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
2231667 C20200021 00336 Estonia See Plans and Pricing PRODUCT NAME: RELEBAKTAAM;REG NO/DATE: EU/1/19/1420 17.02.2020
2231667 2020/029 Ireland See Plans and Pricing PRODUCT NAME: RELEBACTAM OR A MONOHYDRATE THEREOF; REGISTRATION NO/DATE: EU/1/19/1420 20200217
2666774 LUC00167 Luxembourg See Plans and Pricing PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE, EVENTUELLEMENT SOUS FORME DE SEL DE SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217
2666774 301051 Netherlands See Plans and Pricing PRODUCT NAME: RELEBACTAM, DESGEWENST IN DE VORM VAN HET MONOHYDRAAT, EN IMIPENEM; REGISTRATION NO/DATE: EU/1/19/1420 20200217
2231667 301050 Netherlands See Plans and Pricing PRODUCT NAME: RELEBACTAM OF HET MONOHYDRAAT ERVAN; REGISTRATION NO/DATE: EU/1/19/1420 20200217
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim

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