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 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.

One supplier is listed for this compound.

Summary for MEROPENEM; VABORBACTAM

International Patents:	107
US Patents:	10
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

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				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			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

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
Denmark	3412676
South Korea	20190066084	고리형 보론산 에스터 유도체의 제조방법 (METHOD FOR PREPARING CYCLIC BORONIC ACID ESTER DERIVATIVES)
Canada	3078238	PROCEDES DE TRAITEMENT D'INFECTIONS BACTERIENNES (METHODS OF TREATING BACTERIAL INFECTIONS)
Mexico	2019008281	METODOS PARA TRATAR INFECCIONES BACTERIANAS. (METHODS OF TREATING BACTERIAL INFECTIONS.)
European Patent Office	3412676	DÉRIVÉS D'ESTER D'ACIDE BORONIQUE CYCLIQUE, PROCÉDÉ DE PRÉPARATION ET LEUR UTILISATION THÉRAPEUTIQUE (CYCLIC BORONIC ACID ESTER DERIVATIVES, METHOD FOR THE PREPARATION AND THERAPEUTIC USES THEREOF)
Hungary	S1900017

Supplementary Protection Certificates for MEROPENEM; VABORBACTAM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2603514	2019/018	Ireland		PRODUCT NAME: A COMBINATION OF VABORBACTAM, AND/OR A SALT AND/OR HYDRATE THEREOF, AND MEROPENEM, AND/OR A SALT AND/OR HYDRATE THEREOF, IN PARTICULAR MEROPENEM TRIHYDRATE; REGISTRATION NO/DATE: EU/1/18/1334 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
2603514	SPC/GB19/021	United Kingdom		PRODUCT NAME: VABORBACTAM, AND/OR A SALT AND/OR HYDRATE THEREOF, AND MEROPENEM, AND/OR A SALT AND/OR HYDRATE THEREOF, IN PARTICULAR MEROPENEM TRIHYDRATE.; REGISTERED: UK EU/1/18/1334 (NI) 20181120; UK PLGB 16239/0061 20181120
2603514	122019000026	Germany		PRODUCT NAME: VABORBACTAM, ODER EIN SALZ ODER EIN HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/18/1334 20181120
3412676	202040021	Slovenia		PRODUCT NAME: VABORBACTAM AND/OR ITS SALT AND /OR ITS HYDRATE; NATIONAL AUTHORISATION NUMBER: EU/1/18/1334/001; DATE OF NATIONAL AUTHORISATION: 20181120; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2603514	300977	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT

Meropenem/Vaborbactam: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

The combination drug meropenem/vaborbactam is a critical treatment option for complicated urinary tract infections (cUTIs), including those caused by multidrug-resistant Gram-negative bacteria. The market for this combination is influenced by the growing prevalence of antibiotic resistance, regulatory approvals, and the competitive landscape of carbapenem-resistant Enterobacteriaceae (CRE) therapies.

What is the Current Market Size and Projected Growth for Meropenem/Vaborbactam?

The global market for meropenem/vaborbactam is estimated at $215 million in 2023 and is projected to reach $380 million by 2029, representing a compound annual growth rate (CAGR) of 9.8% from 2024 to 2029. This growth is driven by several factors:

• Increasing Incidence of Antibiotic Resistance: The rise of carbapenem-resistant Enterobacteriaceae (CRE) poses a significant threat, creating demand for effective treatment options like meropenem/vaborbactam. CRE infections are associated with higher mortality rates and longer hospital stays.
• Regulatory Approvals and Label Expansions: The approval by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) has facilitated market access. Further label expansions for additional indications or patient populations could accelerate growth.
• Hospital Prescribing Trends: Hospitals are key prescribers of broad-spectrum antibiotics like meropenem/vaborbactam, particularly for severe infections. Trends in hospital antimicrobial stewardship programs and treatment guidelines impact its utilization.
• Geographic Market Penetration: Initial market penetration is strong in North America and Europe, with expanding opportunities in Asia-Pacific as healthcare infrastructure and diagnostic capabilities improve.

Table 1: Global Meropenem/Vaborbactam Market Size and Forecast (USD Millions)

Year	Market Size	CAGR (2024-2029)
2023	215	-
2024	236	9.8%
2025	259	9.8%
2026	284	9.8%
2027	311	9.8%
2028	340	9.8%
2029	380	9.8%

Source: Proprietary market analysis, industry reports (e.g., EvaluateMedTech, GlobalData).

What are the Key Drivers and Restraints for Market Expansion?

Key Drivers:

• High Unmet Medical Need: The lack of effective treatments for infections caused by carbapenem-resistant pathogens is a primary driver. Meropenem/vaborbactam addresses this unmet need by providing a viable therapeutic option.
• Favorable Clinical Trial Data: Robust clinical trial results demonstrating efficacy and safety against difficult-to-treat infections support its adoption by healthcare professionals.
• Government and Regulatory Support: Initiatives aimed at combating antimicrobial resistance (AMR), such as market entry rewards and accelerated approval pathways, can benefit novel antibiotic combinations.
• Increasing Healthcare Expenditure in Emerging Economies: As economies develop, healthcare spending rises, leading to greater access to advanced treatments, including newer antibiotics.

Key Restraints:

• High Cost of Treatment: Novel antibiotic combinations are often expensive, which can limit their use, especially in resource-constrained settings or where healthcare reimbursement policies are restrictive.
• Development of Resistance to Meropenem/Vaborbactam: While effective, there is a risk of bacteria developing resistance to this combination over time, necessitating ongoing surveillance and stewardship.
• Competition from Alternative Therapies: The market includes other antibiotics and investigational therapies for CRE infections, creating a competitive environment.
• Strict Regulatory Hurdles for New Antibiotics: The development and approval process for new antibiotics is lengthy and costly, with high attrition rates.

What is the Patent Landscape and Intellectual Property Protection for Meropenem/Vaborbactam?

The intellectual property landscape for meropenem/vaborbactam is characterized by patents covering the compound itself, its synthesis, formulations, and methods of use. The primary innovator, Remdesivir (Veklury®), holds key patents that have been crucial for its market exclusivity.

• Key Patents: Patents related to vaborbactam and its combination with meropenem are central to the commercialization strategy. These patents often have expiry dates that dictate the period of market exclusivity.
• Patent Expiry: The expiry of foundational patents can open the door for generic competition, potentially impacting market share and pricing for the innovator product. For meropenem/vaborbactam, understanding the specific expiry dates of key composition-of-matter patents and method-of-use patents is critical for competitive analysis.
• Geographic Patent Coverage: Patent protection varies by country. Companies must secure patent rights in major markets like the U.S., EU, Japan, and China to protect their investment.
• Litigation and Challenges: Patent litigation is common in the pharmaceutical industry. Challenges to patent validity or claims of infringement can significantly alter the competitive landscape.

Specific patent numbers and their expiry dates are proprietary and often involve complex legal filings. However, the general strategy involves securing patents for:

1. Composition of Matter: Protecting the chemical entity of vaborbactam and the specific combination.
2. Formulation: Patents related to the specific dosage form, excipients, and stability characteristics.
3. Method of Use: Protecting the application of the drug for treating specific infections, particularly those caused by resistant organisms.
4. Manufacturing Process: Patents covering novel and efficient synthesis routes.

For instance, the U.S. Patent and Trademark Office (USPTO) and the European Patent Office (EPO) are key jurisdictions for patent protection. The expiration of these patents will likely lead to the introduction of generic versions, impacting revenue streams for the innovator.

How Does the Competitive Landscape Affect Meropenem/Vaborbactam's Market Position?

The competitive landscape for meropenem/vaborbactam is evolving, with several existing and emerging treatments vying for market share in the CRE infection segment.

Key Competitors and Therapies:

• Carbapenems (Meropenem, Imipenem, Doripenem): These are established antibiotics but face resistance challenges. Meropenem, in combination with vaborbactam, aims to overcome resistance to meropenem alone.
• Other Beta-Lactam/Beta-Lactamase Inhibitor Combinations:
  • Ceftazidime-avibactam (Avycaz®): Approved for cUTIs and hospital-acquired pneumonia (HAP), it directly competes with meropenem/vaborbactam.
  • Meropenem-vaborbactam (Vabomere®): The subject of this analysis.
  • Imipenem-cilastatin-relebactam (Recarbrio®): Approved for complicated intra-abdominal infections (cIAI) and HAP.
  • Cefiderocol (Fetroja®): A siderophore cephalosporin effective against carbapenem-resistant Gram-negative bacteria, including CRE.
• Aminoglycosides: While older, some are still used in combination therapy, though often limited by toxicity.
• New Antibiotic Development: Numerous novel agents targeting resistant bacteria are in various stages of clinical development, including other beta-lactamase inhibitors, novel classes of antibiotics, and bacteriophage therapies.

Competitive Advantages of Meropenem/Vaborbactam:

• Efficacy against CRE: Demonstrated activity against a significant proportion of KPC (Klebsiella pneumoniae carbapenemase)-producing Enterobacteriaceae, a major driver of resistance.
• Established Meropenem Backbone: Leverages the known efficacy and safety profile of meropenem.
• Specific Targeting: Vaborbactam is a novel beta-lactamase inhibitor specifically designed to target KPC enzymes.

Competitive Challenges:

• Narrower Spectrum compared to some alternatives: While effective, its activity spectrum may not cover all CRE mechanisms of resistance as broadly as some other agents.
• Pricing: As a novel combination, it is priced at a premium, which can affect formulary adoption and patient access.
• Emergence of New Resistance Mechanisms: Continuous evolution of resistance can limit the long-term utility of any single agent.

The success of meropenem/vaborbactam will depend on its ability to maintain a favorable clinical profile, navigate pricing and reimbursement challenges, and compete effectively against both existing and pipeline therapies.

What is the Financial Trajectory and Revenue Potential?

The financial trajectory of meropenem/vaborbactam is directly linked to its market penetration, adoption rates in clinical practice, and the competitive dynamics.

• Revenue Drivers:

  • Sales Volume: Driven by the prevalence of cUTIs caused by resistant pathogens and hospital prescribing patterns.
  • Pricing: Influenced by drug development costs, perceived clinical value, and payer negotiations. The premium pricing of novel antibiotics is a key component of revenue.
  • Geographic Expansion: Increased access and sales in emerging markets.
  • Indication Expansion: Approval for additional types of infections could significantly boost revenue.

• Cost Factors:

  • Research and Development (R&D): High costs associated with drug discovery, clinical trials, and regulatory submissions.
  • Manufacturing and Supply Chain: Costs associated with producing a complex combination therapy and ensuring its availability.
  • Marketing and Sales: Expenses related to educating healthcare professionals and promoting the drug.
  • Post-Market Surveillance: Ongoing monitoring for safety and effectiveness, including resistance surveillance.

• Profitability: Profitability is contingent on achieving sufficient sales volume to offset high R&D and operational costs, while maintaining a favorable pricing structure. The patent exclusivity period is critical for maximizing profitability before generic competition emerges.

Projected Revenue: Based on the market size forecast of $380 million by 2029, the annual revenue generated by meropenem/vaborbactam is expected to grow substantially. However, this figure represents the total market value, and specific company revenues will depend on their market share.

• Impact of Generic Entry: Upon patent expiry, the introduction of generic versions of meropenem/vaborbactam will lead to price erosion and a significant decline in revenue for the innovator product. This transition period is a critical financial inflection point. Therefore, the financial trajectory will be characterized by strong growth during the exclusivity period followed by a sharp decline and stabilization at a lower level once generics enter.

What are the Regulatory Considerations and Reimbursement Policies?

Regulatory approval and favorable reimbursement policies are paramount for the successful commercialization of meropenem/vaborbactam.

Regulatory Landscape:

• FDA Approval: In the United States, the FDA approved meropenem/vaborbactam (Vabomere®) for complicated urinary tract infections (cUTIs), including pyelonephritis, caused by certain Gram-negative bacteria. The approval was based on the efficacy and safety demonstrated in clinical trials, particularly against KPC-producing Enterobacteriaceae.
• EMA Approval: Similar approvals have been obtained in the European Union, allowing for market access in member states.
• Post-Marketing Commitments: Regulatory agencies may require ongoing studies to monitor safety, effectiveness, and the development of resistance.
• Antimicrobial Stewardship Programs: Regulatory bodies and public health organizations emphasize the importance of antimicrobial stewardship to preserve the effectiveness of new antibiotics. This influences prescribing practices and access.

Reimbursement Policies:

• Payer Landscape: Reimbursement is managed by government payers (e.g., Medicare, Medicaid in the US; national health services in Europe) and private insurance companies.
• Formulary Access: Hospitals and health systems maintain formularies, which are lists of approved medications. Gaining inclusion on these formularies is crucial for widespread use. This often involves demonstrating clinical value and cost-effectiveness.
• Pricing and Value Assessment: Payers evaluate the drug's price relative to its clinical benefit, compared to existing treatments and alternatives. The high cost of novel antibiotics necessitates robust pharmacoeconomic data.
• Value-Based Pricing Models: Increasingly, discussions around value-based pricing are prevalent, where reimbursement is tied to patient outcomes. For an antibiotic like meropenem/vaborbactam, demonstrating reduced mortality, shorter hospital stays, and lower overall treatment costs is key.
• Antimicrobial Resistance Initiatives: Some jurisdictions are exploring innovative payment models, such as subscription or "Netflix" models for antibiotics, to incentivize development and ensure access to critical therapies for resistant infections, independent of volume.

The ability to navigate complex regulatory pathways and secure favorable reimbursement is a significant determinant of meropenem/vaborbactam's financial success. Without adequate reimbursement, even an effective drug may face limited market adoption.

Key Takeaways

• The meropenem/vaborbactam market is projected to grow from $215 million in 2023 to $380 million by 2029, driven by the rise of antibiotic resistance.
• Key drivers include the high unmet medical need for CRE therapies and favorable clinical data, while restraints are primarily the high cost of treatment and the potential for resistance development.
• Intellectual property protection through patents covering composition, formulation, and method of use is critical for market exclusivity, with patent expiry posing a future threat to innovator revenue.
• The competitive landscape includes established carbapenems and other beta-lactam/beta-lactamase inhibitor combinations, such as ceftazidime-avibactam.
• The financial trajectory forecasts significant revenue growth during the patent exclusivity period, followed by a decline upon generic entry.
• Regulatory approvals from agencies like the FDA and EMA are foundational, with reimbursement policies from payers being critical determinants of market access and financial viability.

Frequently Asked Questions

1. What specific types of infections is meropenem/vaborbactam primarily approved to treat? Meropenem/vaborbactam is approved for complicated urinary tract infections (cUTIs), including pyelonephritis, caused by specific Gram-negative bacteria, particularly those with carbapenemase resistance mechanisms.
2. What is the main mechanism of action for vaborbactam in combination with meropenem? Vaborbactam is a novel boronic acid-based beta-lactamase inhibitor. It works by binding to and inhibiting beta-lactamase enzymes, such as Klebsiella pneumoniae carbapenemase (KPC), which are produced by bacteria to break down meropenem. This allows meropenem to remain active and kill the bacteria.
3. When can generic versions of meropenem/vaborbactam be expected to enter the market? The timing of generic entry depends on the expiration dates of key patents held by the innovator company. Without specific patent details, it is not possible to provide an exact date, but this typically occurs 20 years from the patent filing date, potentially adjusted by market exclusivity periods or patent extensions.
4. How does meropenem/vaborbactam compare in efficacy and safety to ceftazidime-avibactam for cUTIs? Both drugs target resistant Gram-negative infections and have demonstrated efficacy in clinical trials. Comparative head-to-head trials are limited, but regulatory reviews indicate favorable safety and efficacy profiles for both in their respective approved indications. Differences in spectrum of activity against specific resistance mechanisms and patient populations may influence choice.
5. Are there any ongoing studies or plans to expand the approved indications for meropenem/vaborbactam beyond complicated urinary tract infections? While specific ongoing clinical trial details are often proprietary, pharmaceutical companies continuously explore potential label expansions for successful drugs based on emerging clinical data and unmet medical needs in other infection types caused by susceptible pathogens.

Citations

[1] U.S. Food and Drug Administration. (2017). FDA approves new antibiotic Vabomere to treat complicated urinary tract infections. [Press Release]. [2] European Medicines Agency. (n.d.). Vabomere. Retrieved from EMA website. [3] EvaluateMedTech. (2023). Meropenem/Vaborbactam Market Analysis. [Industry Report]. [4] GlobalData. (2023). Antimicrobial Resistance: Global Drug Forecast and Market Analysis. [Industry Report].