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Last Updated: July 15, 2020

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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 Pharms 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 thirty-nine patent family members in twenty-one countries.

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

Summary for meropenem; vaborbactam
International Patents:39
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 32
Suppliers / Packagers: 1
Clinical Trials: 5
DailyMed Link:meropenem; vaborbactam at DailyMed
Recent Clinical Trials for meropenem; vaborbactam

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

SponsorPhase
Melinta Therapeutics, Inc.Phase 3
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)Phase 1
Biomedical Advanced Research and Development AuthorityPhase 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 Pharms VABOMERE meropenem; vaborbactam POWDER;INTRAVENOUS 209776-001 Aug 29, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Rempex Pharms VABOMERE meropenem; vaborbactam POWDER;INTRAVENOUS 209776-001 Aug 29, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Rempex Pharms VABOMERE meropenem; vaborbactam POWDER;INTRAVENOUS 209776-001 Aug 29, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Rempex Pharms VABOMERE meropenem; vaborbactam POWDER;INTRAVENOUS 209776-001 Aug 29, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 CA 2019 00016 Denmark   Start Trial PRODUCT NAME: VABORBACTAM, OG/ELLER ET SALT OG/ELLER HYDRAT HERAF; REG. NO/DATE: EU/1/18/1334 20181122
2603514 C201930022 Spain   Start Trial PRODUCT NAME: COMBINACION DE VABORBACTAM, Y/O UNA SAL Y/O UN HIDRATO DEL MISMO, Y MEROPENEM, Y/O UNA SAL Y/O UN HIDRATO DEL MISMO, EN PARTICULAR MEROPENM TRIHIDRATO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1334; DATE OF AUTHORISATION: 20181120; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1334; DATE OF FIRST AUTHORISATION IN EEA: 20181120
2603514 122019000026 Germany   Start Trial PRODUCT NAME: VABORBACTAM, UND/ODER EIN SALZ UND/ODER EIN HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/18/1334 20181120
2603514 132019000000051 Italy   Start Trial PRODUCT NAME: COMBINAZIONE DI VABORBACTAM E/O UN SUO SALE E/O UN SUO IDRATO, E MEROPENEM, E/O UN SUO SALE E/O UN SUO IDRATO, IN PARTICOLARE MEROPENEM TRIIDRATO(VABOMERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1334, 20181122
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
McKinsey
McKesson
Boehringer Ingelheim
Johnson and Johnson
Mallinckrodt

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