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

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

One supplier is listed for this compound.

Summary for meropenem; vaborbactam

International Patents:	79
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	8
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

Constraining patent/regulatory exclusivity:

8,680,136

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
Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)	PHASE2
Biomedical Advanced Research and Development Authority	PHASE2
Menarini Group	PHASE2

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	11,376,237
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes	10,183,034
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes	10,172,874		Y
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes	8,680,136		Y	Y

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/004669Vaborem 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
Cyprus	2020019
Canada	2807546	DERIVES CYCLIQUES D'ESTERS D'ACIDE BORONIQUE ET LEURS UTILISATIONS THERAPEUTIQUES (CYCLIC BORONIC ACID ESTER DERIVATIVES AND THERAPEUTIC USES THEREOF)
Japan	7227282
Russian Federation	2599791	ЦИКЛИЧЕСКИЕ БОРОНОВЫЕ КИСЛОТНО-ЭФИРНЫЕ ПРОИЗВОДНЫЕ И ИХ ИСПОЛЬЗОВАНИЕ В ТЕРАПИИ (CYCLIC BORONIC ACID ESTER DERIVATIVES AND THERAPEUTIC USE THEREOF)

Supplementary Protection Certificates for meropenem; vaborbactam

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2603514	C201930023	Spain		PRODUCT NAME: VABORBACTAM, Y/O UNA SAL Y/O UN HIDRATO DEL MISMO; 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
3412676	LUC00169	Luxembourg		PRODUCT NAME: VABORBACTAM, ET/OU UN SEL ET/OU HYDRATE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1334 20181122
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

Market Dynamics and Financial Trajectory for Meropenem; Vaborbactam

Last updated: July 29, 2025

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Introduction

The combination of meropenem and vaborbactam represents a significant advancement in the treatment of multidrug-resistant bacterial infections. This antibiotic combo, marketed primarily under the brand name Vabomere, targeted at combating serious carbapenem-resistant Enterobacteriaceae (CRE) infections, exemplifies the evolving landscape of antimicrobial resistance (AMR) management. As healthcare agencies and providers grapple with escalating resistance, the market trajectory for this drug is shaped by complex dynamics, including regulatory policies, competitive landscape, clinical needs, and economic factors.

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Market Overview and Key Drivers

Antimicrobial Resistance Catalyst

The rising prevalence of multidrug-resistant pathogens, especially CRE, pharmacologically necessitates potent agents like meropenem-vaborbactam. According to the CDC, CRE infections are associated with high mortality rates, limited treatment options, and substantial healthcare costs. This unmet medical need positions meropenem-vaborbactam as a vital therapeutic option, boosting demand globally.[1]

Regulatory Approvals and Adoption Trends

Vabomere received FDA approval in 2017 for complicated urinary tract infections (cUTI), hospital-acquired pneumonia (HAP), and complicated intra-abdominal infections (cIAI). Regulatory endorsement in other regions, such as the European Union and Japan, further broadens its market access. However, rapid adoption is moderated by factors like clinician familiarity, formulary inclusion, and stewardship programs aiming to curb antimicrobial overuse.

Clinical Efficacy and Resistance Trends

Clinical trials consistently demonstrate non-inferiority and sometimes superiority of meropenem-vaborbactam over other agents, particularly in combating CRE infections. Nonetheless, the emergence of resistance—potentially through mechanisms like Vaborbactam's limited activity against non-KPC carbapenemases—may influence long-term market penetration.[2]

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Market Challenges and Constraints

Pricing and Reimbursement Policies

High development costs, coupled with the typically limited duration of antibiotic therapy, create a challenging economic model. Pricing negotiations and reimbursement policies vary by country, impacting access and sales volume.

Antimicrobial Stewardship and Market Penetration

Stewardship programs underscore cautious use of broad-spectrum antibiotics. These initiatives, while vital for public health, constrain immediate widespread utilization, thus affecting short-term revenues.

Competition and Pipeline Developments

Emerging drugs from competitors—such as imipenem/relebactam or meropenem/nacubactam—offer alternatives, intensifying competitive pressures. Additionally, ongoing research into next-generation beta-lactamase inhibitors could influence meropenem-vaborbactam's market share in the coming years.

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Financial Trajectory and Sales Forecasts

Initial Market Performance (2017–2020)

Post-approval, Vabomere experienced steady growth in North America, driven by its efficacy against resistant infections. However, sales growth was tempered by cautious prescribing patterns and high pricing.[3]

Emerging Trends (2021–2025)

With expanding indications and increased global regulatory presence, sales are projected to accelerate moderately. Market research forecasts suggest a compound annual growth rate (CAGR) of approximately 8-10% over this period, driven by increased outbreaks of resistant infections and unmet needs in hospital settings.[4]

Long-term Outlook (2026 and beyond)

As antimicrobial resistance continues to escalate, demand for effective combination therapies like meropenem-vaborbactam is expected to grow. However, resistance development, pricing pressures, and novel competitors could modulate this trajectory. The potential introduction of next-generation inhibitors may pose threats to market dominance, which companies must address via lifecycle strategies such as formulation improvements and expanded indications.

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Market Opportunities and Strategic Implications

Expanding Indications

Development of expanded indications, such as intra-abdominal infections or bloodstream infections, can potentially elevate sales. Additionally, deploying meropenem-vaborbactam in outpatient settings, where feasible, offers growth avenues.

Global Market Penetration

Emerging markets with rising antimicrobial resistance, such as BRICS nations, represent lucrative regions. Strategic partnerships, localized manufacturing, and tailored pricing can enhance penetration.

Combination Therapies and Innovation

Investing in combination strategies and next-generation beta-lactamase inhibitors can sustain relevance amid evolving resistance patterns. Strategic R&D is pivotal to extending lifecycle and maintaining a competitive edge.

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Regulatory and Policy Impact

Regulatory agencies' emphasis on antimicrobial stewardship may initially temper sales growth but ultimately promote sustainable market expansion by encouraging appropriate use. Governmental support, including subsidy programs and inclusion in essential medicines lists, could further influence financial trajectories.

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Conclusion

The market dynamics for meropenem; vaborbactam hinge on the escalating threat of antimicrobial resistance, clinical validation of efficacy, and strategic positioning within the evolving therapeutic landscape. While current sales demonstrate steady growth, long-term success depends on innovation, market expansion, and navigating regulatory and stewardship challenges. The drug remains an essential component in tackling resistant infections, with its financial trajectory poised for upward momentum amid global health priorities.

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Key Takeaways

• The rise of multidrug-resistant infections positions meropenem-vaborbactam as a critical therapeutic, ensuring sustained demand in high-need settings.
• Market growth is moderated by stewardship initiatives, high pricing, and competition; strategic efforts in indications expansion and geographic penetration are vital.
• Developing next-generation inhibitors and novel combinations will be key to maintaining long-term market relevance amidst evolving resistance.
• Policymaker and reimbursement strategies will significantly influence access and sales; proactive engagement can enhance market stability.
• Continuous surveillance of resistance trends, clinical efficacy, and regulatory changes will inform revenue forecasts and investment decisions.

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FAQs

1. What is the primary clinical advantage of meropenem; vaborbactam?
It effectively treats multidrug-resistant Enterobacteriaceae infections, notably carbapenem-resistant strains, by combining meropenem’s broad-spectrum activity with vaborbactam’s beta-lactamase inhibition.

2. How does resistance impact the future market of meropenem-vaborbactam?
Emerging resistance mechanisms, such as non-KPC carbapenemases, can diminish efficacy, prompting the need for next-generation agents and potentially constraining market growth unless adaptive strategies are employed.

3. What are the main barriers to accelerated adoption of this drug?
Stewardship policies, high pricing, clinician familiarity, and limited indications initially slow widespread use, especially in outpatient and resource-constrained settings.

4. Which regions offer the most growth opportunity for meropenem-vaborbactam?
Emerging markets with rising antimicrobial resistance—such as India, Brazil, and China—represent significant growth potential due to increasing healthcare infrastructure and adoption of innovative therapies.

5. What strategies can pharmaceutical companies employ to sustain the market for meropenem; vaborbactam?
Expanding indications, investing in R&D for new formulations, fostering strategic partnerships, and navigating regulatory pathways effectively are crucial for sustained growth.

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References

[1] CDC. Antibiotic Resistance Threats in the United States, 2019. Centers for Disease Control and Prevention.
[2] King, D. et al. (2018). Resistance Mechanisms in Carbapenem-Resistant Enterobacteriaceae. Clinical Infectious Diseases.
[3] EvaluatePharma. Vabomere Sales Data, 2020.
[4] Global Market Insights. (2022). Antimicrobial Resistance Therapeutics Market Forecast.