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Last Updated: May 17, 2022

RECARBRIO Drug Patent Profile


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Which patents cover Recarbrio, and what generic alternatives are available?

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 sixty-three patent family members in thirty-six 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 will be eligible for patent challenges on July 16, 2023. 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 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:63
US Patents:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 4
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 Generic Entry Opportunity 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
Sinovent Pty Ltd.Phase 3
University of Illinois at ChicagoPhase 4
Merck Sharp & Dohme Corp.Phase 4

See all RECARBRIO clinical trials

Pharmacology for RECARBRIO

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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI)

.beta.-lactamase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP)

.beta.-lactamase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS, INCLUDING PYELONEPHRITIS (CUTI)

FDA Regulatory Exclusivity protecting RECARBRIO

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: 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
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 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: See Plans and Pricing

Brazil

Patent: 0906871
Estimated Expiration: See Plans and Pricing

Canada

Patent: 12783
Estimated Expiration: See Plans and Pricing

China

Patent: 1918407
Estimated Expiration: See Plans and Pricing

Patent: 2827067
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 31438
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 626
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0131123
Estimated Expiration: See Plans and Pricing

Patent: 0150269
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 14900
Estimated Expiration: See Plans and Pricing

Patent: 16243
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 31667
Estimated Expiration: See Plans and Pricing

Patent: 66774
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 010000218
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 10010345
Estimated Expiration: See Plans and Pricing

Patent: 10010568
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 31667
Estimated Expiration: See Plans and Pricing

Patent: 66774
Estimated Expiration: See Plans and Pricing

Honduras

Patent: 10001395
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 43809
Estimated Expiration: See Plans and Pricing

Patent: 86180
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 00504
Estimated Expiration: See Plans and Pricing

Patent: 00513
Estimated Expiration: See Plans and Pricing

Patent: 000023
Estimated Expiration: See Plans and Pricing

Patent: 000024
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6395
Estimated Expiration: See Plans and Pricing

Japan

Patent: 38509
Estimated Expiration: See Plans and Pricing

Patent: 22020
Estimated Expiration: See Plans and Pricing

Patent: 97164
Estimated Expiration: See Plans and Pricing

Patent: 11207900
Estimated Expiration: See Plans and Pricing

Patent: 11510012
Estimated Expiration: See Plans and Pricing

Patent: 12214475
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 231667
Estimated Expiration: See Plans and Pricing

Patent: 2020516
Estimated Expiration: See Plans and Pricing

Patent: 2020517
Estimated Expiration: See Plans and Pricing

Patent: 2020518
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 0165
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 2532
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10007823
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 089
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 025
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 1050
Estimated Expiration: See Plans and Pricing

Patent: 1051
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 6861
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 1000115
Estimated Expiration: See Plans and Pricing

Poland

Patent: 31667
Estimated Expiration: See Plans and Pricing

Patent: 66774
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 31667
Estimated Expiration: See Plans and Pricing

Patent: 66774
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 45314
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 052
Estimated Expiration: See Plans and Pricing

Patent: 862
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 31667
Estimated Expiration: See Plans and Pricing

Patent: 66774
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1005333
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1648728
Estimated Expiration: See Plans and Pricing

Patent: 1800610
Estimated Expiration: See Plans and Pricing

Patent: 100130176
Estimated Expiration: See Plans and Pricing

Patent: 160099117
Estimated Expiration: See Plans and Pricing

Spain

Patent: 33744
Estimated Expiration: See Plans and Pricing

Patent: 33826
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 1966
Estimated Expiration: See Plans and Pricing

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
Slovenia 2666774 See Plans and Pricing
South Korea 20160099117 베타­락타마제 억제제 (BETA-LACTAMASE INHIBITORS) See Plans and Pricing
Mexico 2010007823 INHIBIDORES DE BETA-LACTAMASA. (BETA-LACTAMASE INHIBITORS.) See Plans and Pricing
Japan 2012214475 β-LACTAMASE INHIBITOR See Plans and Pricing
Malaysia 162532 BETA-LACTAMASE INHIBITORS See Plans and Pricing
Spain 2433744 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RECARBRIO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2231667 PA2020516,C2231667 Lithuania See Plans and Pricing PRODUCT NAME: RELEBAKTAMAS ARBA JO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1420 20200213
2231667 2020/029 Ireland See Plans and Pricing PRODUCT NAME: RELEBACTAM OR A MONOHYDRATE THEREOF; REGISTRATION NO/DATE: EU/1/19/1420 20200217
2666774 PA2020517 Lithuania See Plans and Pricing PRODUCT NAME: RELEBAKTAMAS, PASIRINKTINAI MONOHIDRATO PAVIDALU, IR IMIPENEMAS; REGISTRATION NO/DATE: EU/1/19/1420 20200213
2231667 2020C/522 Belgium See Plans and Pricing PRODUCT NAME: RELEBACTAM OF HET MONOHYDRAAT ERVAN; 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
McKesson
Baxter
Merck
Medtronic

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.