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Last Updated: June 13, 2021

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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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Meropenem; vaborbactam has forty-nine patent family members in twenty-six countries.

There are thirty-two drug master file entries for meropenem; vaborbactam. One supplier is listed for this compound.

Recent Clinical Trials for meropenem; vaborbactam

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

SponsorPhase
Melinta Therapeutics, Inc.Phase 3
Biomedical Advanced Research and Development AuthorityPhase 1
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)Phase 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   Get Started Free   Get Started Free   Get Started Free
Rempex VABOMERE meropenem; vaborbactam POWDER;INTRAVENOUS 209776-001 Aug 29, 2017 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Rempex VABOMERE meropenem; vaborbactam POWDER;INTRAVENOUS 209776-001 Aug 29, 2017 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Rempex VABOMERE meropenem; vaborbactam POWDER;INTRAVENOUS 209776-001 Aug 29, 2017 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for meropenem; vaborbactam

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2603514 2019C/515 Belgium   Get Started Free DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
3412676 LUC00169 Luxembourg   Get Started Free PRODUCT NAME: VABORBACTAM, ET/OU UN SEL ET/OU HYDRATE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1334 20181122
2603514 19C1022 France   Get Started Free PRODUCT NAME: VABORBACTAM, ET/OU UN SEL ET/OU UN HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/18/1334 20181122
2603514 1990017-4 Sweden   Get Started Free PRODUCT NAME: A COMBINATION OF VABORBACTAM AND/OR SALT OR HYDRATE THEREOF, AND MEROPENEM AND/OR A SALT HYDRATE THEREOF, IN PARTICULAR MEROPENEM TRIHYDRATE.; REG. NO/DATE: EU/1/18/1334 20181122
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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