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Last Updated: April 17, 2024

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VABOMERE Drug Patent Profile


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When do Vabomere patents expire, and what generic alternatives are available?

Vabomere is a drug marketed by Rempex and is included in one NDA. There are seven patents protecting this drug.

This drug has seventy patent family members in thirty countries.

The generic ingredient in VABOMERE is meropenem; vaborbactam. There are thirty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the meropenem; vaborbactam profile page.

DrugPatentWatch® Generic Entry Outlook for Vabomere

Vabomere was eligible for patent challenges on August 29, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 29, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for VABOMERE
Drug Prices for VABOMERE

See drug prices for VABOMERE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VABOMERE
Generic Entry Date for VABOMERE*:
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 VABOMERE

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

SponsorPhase
Biomedical Advanced Research and Development AuthorityPhase 1
Department of Health and Human ServicesPhase 1
Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)Phase 1

See all VABOMERE clinical trials

Pharmacology for VABOMERE

US Patents and Regulatory Information for VABOMERE

VABOMERE is protected by seven US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VABOMERE is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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 VABOMERE

Pharmaceutical compositions comprising cyclic boronic acid ester derivatives
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Therapeutic uses of pharmaceutical compositions comprising cyclic boronic acid ester derivatives
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTION (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI, KLEBSIELLA PNEUMONIA, AND ENTEROBACTER CLOACAE SPECIES COMPLEX

Cyclic boronic acid ester derivatives and therapeutic uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTION (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI, KLEBSIELLA PNEUMONIA, AND ENTEROBACTER CLOACAE SPECIES COMPLEX

Cyclic boronic acid ester derivatives and therapeutic uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI, KLEBSIELLA PNEUMONIA, ENTEROBACTER CLOACAE SPECIES COMPLEX WITH MEROPENEM & VABORBACTAM AS SPECIFIED

Methods of treating bacterial infections
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI,KLEBSIELLA PNEUMONIA,ENTEROBACTER CLOACAE SPECIES COMPLEX WITH MEROPENEM & VABORBACTAM AS SPECIFIED

Cyclic boronic acid ester derivatives and therapeutic uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Cyclic boronic acid ester derivatives and therapeutic uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PATIENTS 18 YEARS OF AGE AND OLDER WITH COMPLICATED URINARY TRACT INFECTIONS CAUSED BY SUSCEPTIBLE MICROORGANISMS

FDA Regulatory Exclusivity protecting VABOMERE

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rempex VABOMERE meropenem; vaborbactam POWDER;INTRAVENOUS 209776-001 Aug 29, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rempex VABOMERE meropenem; vaborbactam POWDER;INTRAVENOUS 209776-001 Aug 29, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Rempex VABOMERE meropenem; vaborbactam POWDER;INTRAVENOUS 209776-001 Aug 29, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for VABOMERE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Menarini International Operations Luxembourg S.A. Vaborem meropenem, vaborbactam EMEA/H/C/004669
Vaborem is indicated for the treatment of the following infections in adults:Complicated urinary tract infection (cUTI), including pyelonephritisComplicated intra-abdominal infection (cIAI)Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.Vaborem is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Authorised no no no 2018-11-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for VABOMERE

When does loss-of-exclusivity occur for VABOMERE?

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

Australia

Patent: 11289615
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2013003045
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 07546
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 13000399
Estimated Expiration: ⤷  Try a Trial

China

Patent: 3180328
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 80667
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0200741
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 03514
Estimated Expiration: ⤷  Try a Trial

Patent: 12676
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 03514
Estimated Expiration: ⤷  Try a Trial

Patent: 12676
Estimated Expiration: ⤷  Try a Trial

Patent: 66778
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 40086
Estimated Expiration: ⤷  Try a Trial

Patent: 48859
Estimated Expiration: ⤷  Try a Trial

Patent: 900017
Estimated Expiration: ⤷  Try a Trial

Patent: 900018
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 4564
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 66978
Estimated Expiration: ⤷  Try a Trial

Patent: 02742
Estimated Expiration: ⤷  Try a Trial

Patent: 54861
Estimated Expiration: ⤷  Try a Trial

Patent: 27282
Estimated Expiration: ⤷  Try a Trial

Patent: 13535502
Estimated Expiration: ⤷  Try a Trial

Patent: 17052794
Estimated Expiration: ⤷  Try a Trial

Patent: 20002178
Estimated Expiration: ⤷  Try a Trial

Patent: 21073212
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 412676
Estimated Expiration: ⤷  Try a Trial

Patent: 412676D
Estimated Expiration: ⤷  Try a Trial

Patent: 2020519
Estimated Expiration: ⤷  Try a Trial

Patent: 2020521
Estimated Expiration: ⤷  Try a Trial

Patent: 12676
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 8960
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 8653
Estimated Expiration: ⤷  Try a Trial

Patent: 13001517
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 7354
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 19013
Estimated Expiration: ⤷  Try a Trial

Patent: 19014
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 03514
Estimated Expiration: ⤷  Try a Trial

Patent: 12676
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 03514
Estimated Expiration: ⤷  Try a Trial

Patent: 12676
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 99791
Estimated Expiration: ⤷  Try a Trial

Patent: 13104951
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 310
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 7757
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 12676
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1987091
Estimated Expiration: ⤷  Try a Trial

Patent: 2087313
Estimated Expiration: ⤷  Try a Trial

Patent: 2205755
Estimated Expiration: ⤷  Try a Trial

Patent: 130099923
Estimated Expiration: ⤷  Try a Trial

Patent: 190066084
Estimated Expiration: ⤷  Try a Trial

Patent: 200028043
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 91468
Estimated Expiration: ⤷  Try a Trial

Patent: 89177
Estimated Expiration: ⤷  Try a Trial

Turkey

Patent: 1815323
Estimated Expiration: ⤷  Try a Trial

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 VABOMERE around the world.

Country Patent Number Title Estimated Expiration
Japan 2013535502 ⤷  Try a Trial
Japan 2020002178 環状ボロン酸エステル誘導体およびその治療的使用 (CYCLIC BORONIC ACID ESTER DERIVATIVES AND THERAPEUTIC USES THEREOF) ⤷  Try a Trial
Serbia 60310 CIKLIČNI DERIVATI ESTRA BORONSKE KISELINE, POSTUPAK ZA PRIPREMU INJIHOVE TERAPEUTSKE UPOTREBE (CYCLIC BORONIC ACID ESTER DERIVATIVES, METHOD FOR THE PREPARATION AND THERAPEUTIC USES THEREOF) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VABOMERE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3412676 PA2020519,C3412676 Lithuania ⤷  Try a Trial PRODUCT NAME: VABORBAKTAMO IR (ARBA) JO DRUSKOS, IR (ARBA) HIDRATO BEI MEROPENEMO IR (ARBA) JO DRUSKOS, IR (ARBA) HIDRATO, YPAC MEROPENEMO TRIHIDRATO, DERINYS; REGISTRATION NO/DATE: EU/1/18/1334 20181120
2603514 2019014 Norway ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF VABORBACTAM, AND/OR A SALT AND/OR HYDRATE THEREOF, AND MEROPENEM, AND/OR A SALT AND/OR HYDRATE THEREOF, IN PARTICULAR MEROPENEM TRIHYDRATE; REG. NO/DATE: EU/1/18/1334/001 20181122
2603514 CA 2019 00015 Denmark ⤷  Try a Trial PRODUCT NAME: EN KOMBINATION AF VABORBACTAM, OG/ELLER ET SALT OG/ELLER HYDRAT DERAF, OG MEROPENEM, OG/ELLER ET SALT OG/ELLER HYDRAT DERAF, SAERLIGT MEROPENEM TRIHYDRAT; REG. NO/DATE: EU/1/18/1334 20181122
>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.