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Last Updated: March 28, 2024

Meropenem; vaborbactam - Generic Drug Details


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What are the generic drug sources for meropenem; vaborbactam and what is the scope of patent protection?

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

Meropenem; vaborbactam has seventy patent family members in thirty countries.

One supplier is listed for this compound.

Summary for meropenem; vaborbactam
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for meropenem; vaborbactam
Generic Entry Date for meropenem; vaborbactam*:
Constraining patent/regulatory exclusivity:
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 meropenem; vaborbactam

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

SponsorPhase
Biomedical Advanced Research and Development AuthorityPhase 1
Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)Phase 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 ⤷  Try a Trial ⤷  Try a Trial Y 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
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 ⤷  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
Rempex VABOMERE meropenem; vaborbactam POWDER;INTRAVENOUS 209776-001 Aug 29, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 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
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 meropenem; vaborbactam

Country Patent Number Title Estimated Expiration
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
Hungary S1900018 ⤷  Try a Trial
New Zealand 607354 Cyclic boronic acid ester derivatives and therapeutic uses thereof ⤷  Try a Trial
Japan 2013535502 ⤷  Try a Trial
Spain 2691468 ⤷  Try a Trial
Canada 3078238 PROCEDES DE TRAITEMENT D'INFECTIONS BACTERIENNES (METHODS OF TREATING BACTERIAL INFECTIONS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for meropenem; vaborbactam

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 C02603514/01 Switzerland ⤷  Try a Trial PRODUCT NAME: VABORBACTAM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67797 01.07.2021
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
3412676 PA2020521 Lithuania ⤷  Try a Trial PRODUCT NAME: VABORBAKTAMAS IR (ARBA) JO DRUSKA, IR (ARBA) JO HIDRATAS; REGISTRATION NO/DATE: EU/1/18/1334 20181120
3412676 C20200017 00315 Estonia ⤷  Try a Trial PRODUCT NAME: MEROPENEEM/VABORBAKTAAM;REG NO/DATE: EU/1/18/1334 22.11.2018
2603514 2019C/515 Belgium ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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