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Last Updated: June 28, 2022

Meropenem; vaborbactam - Generic Drug Details


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What are the generic sources for meropenem; vaborbactam and what is the scope of freedom to operate?

Meropenem; vaborbactam is the generic ingredient in one branded drug marketed by Rempex and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Meropenem; vaborbactam has fifty-three patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for meropenem; vaborbactam
Recent Clinical Trials for meropenem; vaborbactam

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

SponsorPhase
Biomedical Advanced Research and Development AuthorityPhase 1
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)Phase 1
Department of Health and Human ServicesPhase 1

See all meropenem; vaborbactam clinical trials

Pharmacology for meropenem; vaborbactam

US Patents and Regulatory Information for meropenem; vaborbactam

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rempex VABOMERE meropenem; vaborbactam POWDER;INTRAVENOUS 209776-001 Aug 29, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rempex VABOMERE meropenem; vaborbactam POWDER;INTRAVENOUS 209776-001 Aug 29, 2017 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

EU/EMA Drug Approvals for meropenem; vaborbactam

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
VaboremĀ 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

Supplementary Protection Certificates for meropenem; vaborbactam

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3412676 C20200017 00315 Estonia See Plans and Pricing PRODUCT NAME: MEROPENEEM/VABORBAKTAAM;REG NO/DATE: EU/1/18/1334 22.11.2018
2603514 C02603514/02 Switzerland See Plans and Pricing PRODUCT NAME: VABORBACTAM UND MEROPENEM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67797 01.07.2021
3412676 PA2020519 Lithuania See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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