Meropenem; vaborbactam - Generic Drug Details

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

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

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

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
Russian Federation	2013104951	ЦИКЛИЧЕСКИЕ БОРОНОВЫЕ КИСЛОТНО-ЭФИРНЫЕ ПРОИЗВОДНЫЕ И ИХ ИСПОЛЬЗОВАНИЕ В ТЕРАПИИ
Brazil	112020006658	métodos de tratamento de infecções bacterianas
Turkey	201815323

Supplementary Protection Certificates for meropenem; vaborbactam

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2603514	1990019-0	Sweden		PRODUCT NAME: VABORBACTAM, AND /OR A SALT AND/OR HYDRATE THEREOF; REG. NO/DATE: EU/1/18/1334 20181122
2603514	1990017-4	Sweden		PRODUCT NAME: A COMBINATION OF VABORBACTAM AND/OR SALT OR HYDRATE THEREOF, AND MEROPENEM AND/OR A SALT HYDRATE THEREOF, IN PARTICULAR MEROPENEM TRIHYDRATE.; 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

Meropenem; vaborbactam Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Meropenem/Vaborbactam

Introduction

Meropenem/vaborbactam, marketed under the brand name Vabomere, is a significant advancement in the treatment of infections caused by carbapenem-resistant Enterobacterales (CRE). This combination of a carbapenem antibiotic (meropenem) and a beta-lactamase inhibitor (vaborbactam) has garnered considerable attention due to its efficacy against resistant bacterial strains.

Regulatory Approval and Market Entry

Vabomere was approved by the FDA in August 2017 for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible bacteria such as Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae complex[3][5].

Clinical Indications

The drug is indicated for several critical infections, including:

• Complicated urinary tract infections (cUTI), including pyelonephritis
• Complicated intra-abdominal infections (cIAI)
• Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)
• Bacteraemia associated with these infections
• Infections due to aerobic Gram-negative organisms in adults with limited treatment options[3][4].

Market Need and Demand

The rise of antibiotic-resistant bacteria poses a significant threat to public health, making drugs like meropenem/vaborbactam crucial. The global public-private partnership, CARB-X, has invested heavily in advancing such antibacterial products, including meropenem/vaborbactam, to address this urgent need[2].

Efficacy and Safety Profile

Meropenem/vaborbactam has shown a favorable efficacy and safety profile. It exhibits potent activity against CRE, particularly those producing KPC enzymes, with a high susceptibility rate of 99.1% against KPC-producing isolates[4]. The combination also demonstrates a low propensity for resistance development and reduced nephrotoxicity compared to older combination therapies[1].

Pharmacokinetics and Distribution

Both meropenem and vaborbactam have favorable pharmacokinetic properties, including good intrapulmonary penetration and efficient clearance during continuous venovenous hemofiltration (CVVH). The low protein binding and high volume of distribution contribute to their effective tissue and body fluid penetration[1].

Financial Performance

Since its approval, Vabomere has seen steady sales growth. In the first nine quarters following its launch in 2018, it generated $21.81 million in sales[3]. The financial trajectory is expected to remain positive due to the increasing demand for effective treatments against antibiotic-resistant infections.

Patent and Exclusivity

Vabomere is protected by several patents, with the earliest generic entry expected in August 2031, subject to patent challenges or generic licensing agreements[5]. This exclusivity period ensures a significant market share for the branded product in the coming years.

Competitive Landscape

The market for antibacterial drugs is highly competitive, but meropenem/vaborbactam stands out due to its unique mechanism of action and broad spectrum of activity against resistant bacteria. It competes with other recently approved drugs like plazomicin and eravacycline, which have also been supported by regulatory bodies like BARDA[2].

Global Reach and Approval

In addition to FDA approval, meropenem/vaborbactam has been approved in Europe for various indications, including cUTI, cIAI, HAP, and VAP. This broader approval enhances its global market potential[4].

Investment and Research Support

The development and approval of meropenem/vaborbactam have been supported by significant investments from public-private partnerships like CARB-X and regulatory bodies such as BARDA and the NIH. These investments underscore the importance of this drug in combating antibiotic resistance[2].

Future Outlook

Given the ongoing threat of antibiotic resistance and the drug's proven efficacy, the market dynamics for meropenem/vaborbactam are expected to remain strong. As resistance patterns evolve, the need for effective treatments like Vabomere will continue to drive demand.

Key Takeaways

• Regulatory Approval: Approved by FDA in August 2017 and in Europe for multiple indications.
• Clinical Indications: Effective against cUTI, cIAI, HAP, VAP, and bacteraemia.
• Efficacy and Safety: High susceptibility rate against KPC-producing CRE and reduced nephrotoxicity.
• Pharmacokinetics: Favorable properties including good tissue penetration and efficient clearance.
• Financial Performance: Steady sales growth with significant market exclusivity until 2031.
• Competitive Landscape: Unique mechanism of action sets it apart in the competitive antibacterial market.
• Global Reach: Approved in both the U.S. and Europe, enhancing global market potential.
• Investment and Research Support: Supported by public-private partnerships and regulatory bodies.

FAQs

What are the primary indications for meropenem/vaborbactam?

Meropenem/vaborbactam is indicated for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and bacteraemia associated with these infections.

How does meropenem/vaborbactam address antibiotic resistance?

Meropenem/vaborbactam combines a carbapenem antibiotic with a beta-lactamase inhibitor, which effectively inhibits class A and C beta-lactamases, including KPC enzymes, thereby retaining activity against carbapenem-resistant Enterobacterales.

What is the pharmacokinetic profile of meropenem/vaborbactam?

Both meropenem and vaborbactam have favorable pharmacokinetic properties, including low protein binding, good intrapulmonary penetration, and efficient clearance during continuous venovenous hemofiltration (CVVH).

When is the earliest generic entry expected for meropenem/vaborbactam?

The earliest generic entry for meropenem/vaborbactam is expected in August 2031, subject to patent challenges or generic licensing agreements.

What public-private partnerships have supported the development of meropenem/vaborbactam?

The development of meropenem/vaborbactam has been supported by public-private partnerships such as CARB-X, BARDA, NIH/NIAID, the Wellcome Trust, and the Bill & Melinda Gates Foundation.

Sources

1. Meropenem/vaborbactam: a next generation β-lactam β-lactamase inhibitor combination - Tandfonline
2. Priorities for the National Action Plan on Combating Antibiotic-Resistant Bacteria - HHS
3. Vabomere (meropenem and vaborbactam) Information - NCBI
4. Activity of meropenem/vaborbactam and comparators against Gram-negative bacteria - Oxford Academic
5. VABOMERE Patents and Exclusivity - Drug Patent Watch