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Last Updated: August 4, 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
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 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 Y   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 2019C/515 Belgium   Start Trial PRODUCT NAME: VABORBACTAM ET / OU D'UN DE SES SELS ET / OU HYDRATES; AUTHORISATION NUMBER AND DATE: EU/1/18/1334 20181122
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 300977 Netherlands   Start Trial PRODUCT NAME: EEN COMBINATIE VAN VABORBACTAM, EN/OF EEN ZOUT EN/OF EEN HYDRAAT DAARVAN, EN MEROPENEM, EN/OF EEN ZOUT EN/OF EEN HYDRAAT DAARVAN, IN HET BIJZONDER MEROPENEM TRIHYDRAAT; REGISTRATION NO/DATE: 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:

McKesson
Medtronic
Johnson and Johnson
Boehringer Ingelheim
Baxter
Colorcon

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