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Last Updated: May 24, 2024

~ Buy the RECARBRIO (cilastatin sodium; imipenem; relebactam) Drug Profile, 2024 PDF Report in the Report Store ~

RECARBRIO Drug Patent Profile


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When do Recarbrio patents expire, and when can generic versions of Recarbrio launch?

Recarbrio is a drug marketed by Msd Merck Co and is included in one NDA. There is one patent protecting this drug.

This drug has seventy-one patent family members in thirty-eight countries.

The generic ingredient in RECARBRIO is cilastatin sodium; imipenem; relebactam. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cilastatin sodium; imipenem; relebactam profile page.

DrugPatentWatch® Generic Entry Outlook for Recarbrio

Recarbrio was eligible for patent challenges on July 16, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 19, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for RECARBRIO
International Patents:71
US Patents:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 5
Formulation / Manufacturing:see details
Drug Prices: Drug price information for RECARBRIO
What excipients (inactive ingredients) are in RECARBRIO?RECARBRIO excipients list
DailyMed Link:RECARBRIO at DailyMed
Drug patent expirations by year for RECARBRIO
Drug Prices for RECARBRIO

See drug prices for RECARBRIO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RECARBRIO
Generic Entry Date for RECARBRIO*:
Constraining patent/regulatory exclusivity:
NDA:
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 RECARBRIO

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

SponsorPhase
University of Texas Southwestern Medical CenterPhase 4
Q2 SolutionsPhase 4
Indiana University Health Methodist HospitalPhase 4

See all RECARBRIO clinical trials

US Patents and Regulatory Information for RECARBRIO

RECARBRIO is protected by three US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RECARBRIO is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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 RECARBRIO

.beta.-lactamase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI)

.beta.-lactamase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP)

.beta.-lactamase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS, INCLUDING PYELONEPHRITIS (CUTI)

FDA Regulatory Exclusivity protecting RECARBRIO

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷  Sign Up

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 Y Y ⤷  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 ⤷  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 RECARBRIO

When does loss-of-exclusivity occur for RECARBRIO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 09206119
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0906871
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 12783
Estimated Expiration: ⤷  Sign Up

China

Patent: 1918407
Estimated Expiration: ⤷  Sign Up

Patent: 2827067
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 31438
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 626
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0131123
Estimated Expiration: ⤷  Sign Up

Patent: 0150269
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 14900
Estimated Expiration: ⤷  Sign Up

Patent: 16243
Estimated Expiration: ⤷  Sign Up

Patent: 20023
Estimated Expiration: ⤷  Sign Up

Patent: 20024
Estimated Expiration: ⤷  Sign Up

Patent: 20025
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 31667
Estimated Expiration: ⤷  Sign Up

Patent: 66774
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 010000218
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 10010345
Estimated Expiration: ⤷  Sign Up

Patent: 10010568
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 31667
Estimated Expiration: ⤷  Sign Up

Patent: 66774
Estimated Expiration: ⤷  Sign Up

France

Patent: C1030
Estimated Expiration: ⤷  Sign Up

Patent: C1031
Estimated Expiration: ⤷  Sign Up

Patent: C1032
Estimated Expiration: ⤷  Sign Up

Honduras

Patent: 10001395
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 43809
Estimated Expiration: ⤷  Sign Up

Patent: 86180
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 00504
Estimated Expiration: ⤷  Sign Up

Patent: 00513
Estimated Expiration: ⤷  Sign Up

Patent: 000023
Estimated Expiration: ⤷  Sign Up

Patent: 000024
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 6395
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 38509
Estimated Expiration: ⤷  Sign Up

Patent: 22020
Estimated Expiration: ⤷  Sign Up

Patent: 97164
Estimated Expiration: ⤷  Sign Up

Patent: 11207900
Estimated Expiration: ⤷  Sign Up

Patent: 11510012
Estimated Expiration: ⤷  Sign Up

Patent: 12214475
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 231667
Estimated Expiration: ⤷  Sign Up

Patent: 666774
Estimated Expiration: ⤷  Sign Up

Patent: 2020516
Estimated Expiration: ⤷  Sign Up

Patent: 2020517
Estimated Expiration: ⤷  Sign Up

Patent: 2020518
Estimated Expiration: ⤷  Sign Up

Luxembourg

Patent: 0165
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 2532
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 10007823
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 089
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 025
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 1050
Estimated Expiration: ⤷  Sign Up

Patent: 1051
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 6861
Estimated Expiration: ⤷  Sign Up

Nicaragua

Patent: 1000115
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 20024
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 31667
Estimated Expiration: ⤷  Sign Up

Patent: 66774
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 31667
Estimated Expiration: ⤷  Sign Up

Patent: 66774
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 45314
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 052
Estimated Expiration: ⤷  Sign Up

Patent: 862
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 31667
Estimated Expiration: ⤷  Sign Up

Patent: 66774
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1005333
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1648728
Estimated Expiration: ⤷  Sign Up

Patent: 1800610
Estimated Expiration: ⤷  Sign Up

Patent: 100130176
Estimated Expiration: ⤷  Sign Up

Patent: 160099117
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 33744
Estimated Expiration: ⤷  Sign Up

Patent: 33826
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 1966
Estimated Expiration: ⤷  Sign Up

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 RECARBRIO around the world.

Country Patent Number Title Estimated Expiration
Cyprus 1114900 ⤷  Sign Up
Canada 2712783 INHIBITEURS DE LA BETA-LACTAMASE (BETA-LACTAMASE INHIBITORS) ⤷  Sign Up
Slovenia 2231667 ⤷  Sign Up
Hong Kong 1143809 BETA-LACTAMASE INHIBITORS ⤷  Sign Up
Netherlands 301050 ⤷  Sign Up
Hungary S000513 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RECARBRIO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2666774 122020000036 Germany ⤷  Sign Up PRODUCT NAME: RELEBACTAM, ODER RELEBACTAM IN FORM DES MONOHYDRATES, IMIPENEM UND CILASTATIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1420 20200213
2231667 PA2020516 Lithuania ⤷  Sign Up PRODUCT NAME: RELEBAKTAMAS ARBA JO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1420 20200213
2231667 C20200021 00336 Estonia ⤷  Sign Up PRODUCT NAME: RELEBAKTAAM;REG NO/DATE: EU/1/19/1420 17.02.2020
2666774 2020024 Norway ⤷  Sign Up PRODUCT NAME: KOMBINASJON AV RELEBAKTAM EVENTUELT I FORM AV MONOHYDRAT, IMIPENEM OG CILASTATIN, EVENTUELT I FORM AV NATRIUMSALT; REG. NO/DATE: EU/1/19/1420 20200219
2231667 30/2020 Austria ⤷  Sign Up PRODUCT NAME: RELEBACTAM ODER EIN MONOHYDRAT DAVON; REGISTRATION NO/DATE: EU/1/19/1420 (MITTEILUNG) 20200217
2666774 2020C/523 Belgium ⤷  Sign Up DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.