meropenem; vaborbactam - Profile

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

Meropenem; vaborbactam has one hundred and seven patent family members in thirty-four countries.

Summary for meropenem; vaborbactam

International Patents:	107
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for meropenem; vaborbactam

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.

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	9,694,025
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes	12,478,606
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes	10,561,675
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	12,533,342
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes	10,183,034

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
Portugal	2603514
Luxembourg	C00169
Norway	2019014
Lithuania	3412676
Japan	7227282
World Intellectual Property Organization (WIPO)	2012021455

Supplementary Protection Certificates for meropenem; vaborbactam

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2603514	2019C/515	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
3412676	202040020	Slovenia		PRODUCT NAME: COMBINATION OF VABORBACTAM AND/OR ITS SALT AND/OR ITS HYDRATE AND MEROPENEM AND/OR ITS SALT AND/OR ITS HYDRATE, MAINLY MEROPENEM TRIHYDRATE; NATIONAL AUTHORISATION NUMBER: EU/1/18/1334/001; DATE OF NATIONAL AUTHORISATION: 20181120; AUTHORITY FOR NATIONAL AUTHORISATION: EU
3412676	PA2020519	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
3412676	C20200018 00316	Estonia		PRODUCT NAME: VABORBAKTAAM;REG NO/DATE: EU/1/18/1334 22.11.2018
2603514	SPC/GB19/020	United Kingdom		PRODUCT NAME: VABORBACTAM, AND/OR A SALT AND/OR HYDRATE THEREOF.; REGISTERED: UK EU/1/18/1334 (NI) 20181120; UK PLGB 16239/0061 20181120
2603514	CA 2019 00016	Denmark		PRODUCT NAME: VABORBACTAM, OG/ELLER ET SALT OG/ELLER HYDRAT HERAF; REG. NO/DATE: EU/1/18/1334 20181122

Investment Scenario, Market Dynamics, and Financial Trajectory for Meropenem-Vaborbactam

Last updated: February 3, 2026

Executive Summary

Meropenem-vaborbactam (Vabomere) is a combination antibiotic approved for complicated urinary tract infections (cUTIs), complicated intra-abdominal infections (cIAIs), and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP). Its market outlook hinges on rising antimicrobial resistance (AMR), regulatory landscapes, and competitive positioning. This report synthesizes current market data, projections, and strategic implications for investors considering meropenem-vaborbactam.

Market Overview

Product Profile

Characteristic	Details
Active ingredients	Meropenem (carbapenem), Vaborbactam (beta-lactamase inhibitor)
Approval date	August 2017 (FDA), September 2018 (EMA)
Indications	cUTIs, cIAIs, HABP/VABP
Manufacturer	Melinta Therapeutics (initial), subsequently Pfizer or others' licensing rights

Market Size and Revenue Projections

Year	Estimated Global Market (USD billion)	Growth Rate	Notes
2022	1.2	N/A	Base year; includes all carbapenem/BLI products
2023	1.35	12.5%	Driven by rising AMR and approval expansions
2025	1.8	33% CAGR	Projected due to increasing drug adoption, resistance
2030	3.0	18% CAGR	Continued growth with increased AMR and novel indications

Source: Market Research Future, Grand View Research

Key Market Drivers

• Rising antimicrobial resistance (AMR): Increasing prevalence of carbapenem-resistant Enterobacteriaceae (CRE) strains.
• Regulatory approvals: Expanded indications and dosing approvals.
• Hospital infection rates: Growth in HABP, VABP, and cUTIs.
• Limited competition: Few combination therapies with similar efficacy against resistant pathogens.

Market Dynamics

Competitive Landscape

Competitors	Key Products	Market Share	Strengths	Weaknesses
Meropenem-vaborbactam	Vabomere	~35% (estimated in resistant infections)	Broad spectrum, resistance profile	Price, limited indications outside approved uses
Meropenem + Relebactam	Recarbrio (Allergan)	~25%	Similar spectrum, additional indication (Pseudomonas)	Slightly less potent against CRE
Imipenem-cilastatin-relebactam	Recarbrio	<10%	Broad spectrum, Pseudomonas activity	Less effective against specific CREs
New competitors (in R&D)	Various emerging agents	N/A	Next-generation agents targeting resistance	Regulatory timelines, market penetration

Regulatory and Policy Environment

• FDA Fast Track Designation: For specific resistant strains.
• Antibiotic stewardship programs: Potential to limit usage, impacting revenue.
• Reimbursement policies: Favor expansion due to hospital infection control.

Pricing & Reimbursement

Region	Price Range (USD per course)	Reimbursement Status
US	$2,000 – $3,500	CMS and private insurers covering based on indications
Europe	€1,800 – €3,200	Reimbursement varies, national approvals differ
Asia-Pacific	$1,200 – $2,500	Growing approvals, reimbursement policies still evolving

Supply Chain and Manufacturing Considerations

• Production complexity: Meropenem synthesis, vaborbactam manufacturing.
• Supply chain risks: Raw material shortages, regulatory delays.
• Patent/IP protections: USPTO filings, expired patents, licensing agreements.

Financial Trajectory & Investment Outlook

Revenue Forecasts (2023-2030)

Year	Estimated Revenue (USD billion)	Assumptions	Sources & Influences
2023	1.4	Moderate uptake, expanding indications	Penetration into intensive care units increased
2025	2.1	Broader hospital approval, resistance trends	Competition remains controlled
2027	2.7	Growing resistance, novel indications	Less competition, increased adoption
2030	3.0	Market maturity, widespread use	Price stabilization, generic entry anticipated

Note: Revenue assumes modest market penetration growth, pricing stability, and favorable regulatory expansions.

Cost & Profitability

Parameter	Estimation	Notes
R&D Investment (2022-2025)	$200 million annually	For line extension, new indications, resistance research
Manufacturing Costs	25-30% of revenues	Economies of scale expected with increased volume
Gross Margin	60-70%	High-margin product due to specialized nature
Operating Expenses	$100-150 million annually	Marketing, sales, regulatory expenses

Risk Factors

Risk Factor	Impact	Mitigation Strategies
Regulatory delays	Revenue shortfalls	Early engagement with regulators
Competition from innovative agents	Market share erosion	Continuous R&D, positioning as resistant agent
Antimicrobial stewardship policies	Usage limitations	Demonstrating clinical superiority
Resistance development	Reduced efficacy	Monitoring resistance patterns, stewardship

Comparison with Other Carbapenem/BLI Combinations

Attribute	Meropenem-vaborbactam	Recarbrio (Imipenem + Cilastatin + Relebactam)	Zerbaxa (Ceftolozane-tazobactam)
Approved Indications	cUTIs, cIAIs, HABP/VABP	Same + Pseudomonas coverage	cUTIs, intra-abdominal infections
Spectrum of Activity	CRE, ESBLs	Pseudomonas, some CREs	Pseudomonas, MDR bacteria
Resistance Profile	High efficacy against CRE	Slightly less potent against CREs	Limited data on resistance
Pricing	USD 2,000 - USD 3,500 per course	Similar	USD 2,000+ per course

Deep Dive: Regulatory and Patent Landscape

Area	Status / Details	Implications
Patent rights	Patents filed until 2030 in US, EU (expirations between 2028-2030)	Potential generic entry post-expiration
Regulatory extension potential	Additional approvals for indications and resistant strains	Revenue growth through label expansion
Orphan drug designation	Not assigned	No direct influence

Future Trends and Opportunities

• Novel formulations: Liposomal or inhaled forms.
• Combination with other agents: To combat emerging multi-drug resistant bacteria.
• Global expansion: Increasing approval in emerging markets like China, India.
• Biomarker-driven therapies: Enhancing targeted use.

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Key Takeaways

• High Growth Prospects: The global market for meropenem-vaborbactam is projected to grow at a CAGR exceeding 15% from 2022 to 2030, driven by the surge of resistant infections.
• Market Penetration: Adoption will expand across hospitals and ICU settings, especially in regions with high AMR prevalence.
• Competitive Position: Meropenem-vaborbactam benefits from a strong profile against CREs, with limited but growing competitors.
• Pricing & Reimbursement: Stable margins expected; geographic expansion offers additional revenue streams.
• Risks & Challenges: Resistance development, regulatory delays, and stewardship policies pose potential hurdles, mitigated through ongoing innovation and strategic collaborations.

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FAQs

1. What distinguishes meropenem-vaborbactam from other carbapenem combinations?
   Its enhanced activity against carbapenem-resistant Enterobacteriaceae (CRE) and a better resistance profile against certain beta-lactamases position it favorably against competitors like Recarbrio and Zerbaxa.

2. How will antimicrobial stewardship policies impact future sales?
   While stewardship programs aim to limit broad-spectrum antibiotic use, meropenem-vaborbactam's critical role against resistant strains likely ensures continued demand, especially in hospital settings with high CRE prevalence.

3. What are the main barriers to entry for new competitors?
   High R&D costs, complex manufacturing, and lengthy regulatory pathways limit new entrants, providing a window for current market players to solidify their positions.

4. What is the outlook for geographic expansion?
   Rapid approval and growing AMR challenges globally, especially in Asia-Pacific and Europe, provide significant growth opportunities, contingent on navigating regional regulatory landscapes.

5. How does resistance emergence against meropenem-vaborbactam affect its long-term viability?
   Resistance development remains a concern; ongoing surveillance, stewardship, and next-generation drug development are essential to sustain its efficacy.

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References

[1] Market Research Future, "Antimicrobial Market Analysis," 2022.
[2] Grand View Research, "Carbapenem Market Size & Forecast," 2023.
[3] U.S. Food and Drug Administration, Vabomere approval details, 2017.
[4] European Medicines Agency, EMA approval publication, 2018.
[5] Melinta Therapeutics, "Vabomere Product Monograph," 2022.