MEROPENEM; VABORBACTAM - Generic Drug Details

What are the generic 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

International Patents:	70
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	5
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MEROPENEM; VABORBACTAM
DailyMed Link:	MEROPENEM; VABORBACTAM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MEROPENEM; VABORBACTAM

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

Sponsor	Phase
Biomedical Advanced Research and Development Authority	Phase 1
Department of Health and Human Services	Phase 1
Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)	Phase 1

See all MEROPENEM; VABORBACTAM clinical trials

Pharmacology for MEROPENEM; VABORBACTAM

Drug Class	Penem Antibacterial beta Lactamase Inhibitor
Mechanism of Action	beta Lactamase Inhibitors

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
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes			Y	Y
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes			Y
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes

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

International Patents for MEROPENEM; VABORBACTAM

Country	Patent Number	Title	Estimated Expiration
Lithuania	PA2020519
Croatia	P20200741
European Patent Office	3666778	UN DÉRIVÉ CRISTALLIN D'ESTER D'ACIDE BORONIQUE CYCLIQUE, PROCÉDÉ DE PRÉPARATION ET UTILISATION THÉRAPEUTIQUES (A CRYSTALLINE CYCLIC BORONIC ACID ESTER DERIVATIVE, METHOD FOR THE PREPARATION AND THERAPEUTIC USES THEREOF)
European Patent Office	2603514	DÉRIVÉS CYCLIQUES D'ESTERS D'ACIDE BORONIQUE ET LEURS UTILISATIONS THÉRAPEUTIQUES (CYCLIC BORONIC ACID ESTER DERIVATIVES AND THERAPEUTIC USES THEREOF)
Portugal	2603514
South Korea	102205755
Canada	2807546	DERIVES CYCLIQUES D'ESTERS D'ACIDE BORONIQUE ET LEURS UTILISATIONS THERAPEUTIQUES (CYCLIC BORONIC ACID ESTER DERIVATIVES AND THERAPEUTIC USES THEREOF)

Supplementary Protection Certificates for MEROPENEM; VABORBACTAM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2603514	2019/017	Ireland		PRODUCT NAME: VABORBACTAM, AND/OR A SALT AND/OR HYDRATE THEREOF; AUTHORISATION NO/DATE: EU/1/18/1334 20181120
3412676	LUC00168	Luxembourg		PRODUCT NAME: COMBINAISON DE VABORBACTAM, ET/OU D'UN SEL ET/OU D'UN HYDRATE DE CELUI-CI, ET DE MEROPENEME, ET/OU D'UN SEL ET/OU D'UN HYDRATE DE CELUI-CI, EN PARTICULIER DE MEROPENEME TRIHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/18/1334 20181122
2603514	19C1022	France		PRODUCT NAME: VABORBACTAM, ET/OU UN SEL ET/OU UN HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/18/1334 20181122
2603514	CA 2019 00016	Denmark		PRODUCT NAME: VABORBACTAM, OG/ELLER ET SALT OG/ELLER HYDRAT HERAF; REG. NO/DATE: EU/1/18/1334 20181122
2603514	CA 2019 00015	Denmark		PRODUCT NAME: EN KOMBINATION AF VABORBACTAM, OG/ELLER ET SALT OG/ELLER HYDRAT DERAF, OG MEROPENEM, OG/ELLER ET SALT OG/ELLER HYDRAT DERAF, SAERLIGT MEROPENEM TRIHYDRAT; REG. NO/DATE: EU/1/18/1334 20181122
3412676	PA2020519,C3412676	Lithuania		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
2603514	132019000000051	Italy		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