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

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

One supplier is listed for this compound.

Summary for meropenem; vaborbactam

International Patents:	76
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

Generic Entry Date for meropenem; vaborbactam^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)	Phase 1
Department of Health and Human Services	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

Anatomical Therapeutic Chemical (ATC) Classes for meropenem; vaborbactam

J01DH	Carbapenems
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01DH	Carbapenems
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for meropenem; vaborbactam

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Glossary

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

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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

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Country	Patent Number	Title	Estimated Expiration
Singapore	11202003009Q	METHODS OF TREATING BACTERIAL INFECTIONS	⤷ Sign Up
Cyprus	1123208		⤷ Sign Up
South Korea	20200028043	고리형 보론산 에스터 유도체의 제조방법 (METHOD FOR PREPARING CYCLIC BORONIC ACID ESTER DERIVATIVES)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for meropenem; vaborbactam

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2603514	C201930022	Spain	⤷ Sign Up	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	2019013	Norway	⤷ Sign Up	PRODUCT NAME: VABORBACTAM, AND/OR A SALT AND/OR HYDRATE THEREOF; REG. NO/DATE: EU/1/18/1334 20181113
3412676	PA2020519,C3412676	Lithuania	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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