VABOMERE Drug Patent Profile

Which patents cover Vabomere, and when can generic versions of Vabomere launch?

Vabomere is a drug marketed by Rempex and is included in one NDA. There are ten patents protecting this drug.

This drug has one hundred and seven patent family members in thirty-four countries.

The generic ingredient in VABOMERE is meropenem; vaborbactam. There are thirty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the meropenem; vaborbactam profile page.

DrugPatentWatch^® Generic Entry Outlook for Vabomere

Vabomere was eligible for patent challenges on August 29, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 29, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VABOMERE

International Patents:	107
US Patents:	10
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VABOMERE

US Patents and Regulatory Information for VABOMERE

VABOMERE is protected by ten US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 8,680,136.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	11,007,206
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes	11,376,237

International Patents for VABOMERE

When does loss-of-exclusivity occur for VABOMERE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

New Zealand

Norway

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Korea

Spain

Turkey

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VABOMERE around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20190104385	세균 감염을 치료하는 방법
Luxembourg	C00168
Portugal	3565551

Supplementary Protection Certificates for VABOMERE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3412676	C20200018 00316	Estonia		PRODUCT NAME: VABORBAKTAAM;REG NO/DATE: EU/1/18/1334 22.11.2018
2603514	CA 2019 00016	Denmark		PRODUCT NAME: VABORBACTAM, OG/ELLER ET SALT OG/ELLER HYDRAT HERAF; REG. NO/DATE: EU/1/18/1334 20181122
2603514	2019014	Norway		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; REG. NO/DATE: EU/1/18/1334/001 20181122

VABOMERE: Patent Landscape and Investment Fundamentals

Last updated: February 19, 2026

This analysis details the patent landscape and market fundamentals for Vabomere (meropenem-vaborbactam), a novel antibiotic for complicated urinary tract infections. Vabomere addresses the growing threat of carbapenem-resistant Enterobacteriaceae (CRE). Key patent expirations and potential market entry by generics are assessed.

What is Vabomere and Its Therapeutic Target?

Vabomere is a combination antibiotic consisting of meropenem, a broad-spectrum carbapenem antibiotic, and vaborbactam, a novel beta-lactamase inhibitor. It is approved for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by specific susceptible Gram-negative microorganisms. The critical threat it addresses is infections caused by carbapenem-resistant Enterobacteriaceae (CRE), a class of bacteria that has become increasingly difficult to treat with existing antibiotics.

• Mechanism of Action: Meropenem inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins. Vaborbactam is a cyclic boronic acid that inhibits class A, C, and D beta-lactamases, including carbapenemases like KPC (Klebsiella pneumoniae carbapenemase) and OXA-48-like enzymes. This combination restores the activity of meropenem against bacteria that produce these resistance enzymes [1].
• Indication: Vabomere is indicated for patients 18 years of age and older for the treatment of cUTI, including pyelonephritis, caused by aerobic Gram-negative bacteria that are susceptible to meropenem. This includes infections due to Enterobacteriaceae resistant to at least one of the following agents: carbapenems, piperacillin-tazobactam, ceftazidime, or cefepime [2].

What is the Patent Protection for Vabomere?

Vabomere's patent protection is multifaceted, covering the active pharmaceutical ingredients (API) combination, manufacturing processes, and specific indications. The core patents are held by Melinta Therapeutics and its affiliates.

• Composition of Matter Patents: The fundamental patent protection for the vaborbactam molecule and its combination with meropenem is crucial. These patents typically offer the longest exclusivity periods.
• Process Patents: Patents covering novel or improved methods of manufacturing the vaborbactam-meropenem combination provide additional layers of protection, often extending beyond the initial composition of matter expiry.
• Formulation Patents: Patents related to specific pharmaceutical formulations, such as intravenous solutions or specific ratios of the APIs, can also extend market exclusivity.
• Indication Patents: In some cases, patents can be obtained for the use of a drug in treating a specific disease or condition.

When Do Key Vabomere Patents Expire?

The expiry of key patents is a critical determinant of generic competition and future market dynamics. Vabomere's patent portfolio is complex, with multiple patents and varying expiry dates.

• Core Composition of Matter Patents: The earliest significant patent expiries for the vaborbactam molecule and its combination with meropenem are anticipated in the mid-to-late 2020s.
  • U.S. Patent No. 9,084,728, covering certain pharmaceutical compositions comprising vaborbactam and meropenem, is listed with an expiry date of July 15, 2029 [3].
  • U.S. Patent No. 8,933,070, also related to pharmaceutical compositions of vaborbactam and meropenem, has an expiry date of July 15, 2029 [3].
• Additional Patents: Other patents within the Vabomere portfolio may extend exclusivity for specific formulations or manufacturing processes. For instance, certain formulation patents could extend into the early 2030s. However, the primary driver of generic entry will be the expiry of the core composition of matter patents.
• Hatch-Waxman Exclusivities: Beyond patent protection, Vabomere benefits from statutory exclusivity periods granted under the Hatch-Waxman Act.
  • New Chemical Entity (NCE) Exclusivity: Vaborbactam, as a novel component, likely qualified for 5 years of NCE exclusivity upon its approval.
  • Orphan Drug Exclusivity: If Vabomere was designated for a rare disease or condition, it could have received 7 years of orphan drug exclusivity. However, its primary indication (cUTI) is not typically considered rare.
  • Pediatric Exclusivity: Additional 6-month exclusivity can be granted if pediatric studies are conducted and approved.

Table 1: Key Vabomere Patent Expiries (United States)

Patent Number	Title/Description	Expiry Date
9,084,728	Pharmaceutical Compositions	July 15, 2029
8,933,070	Pharmaceutical Compositions	July 15, 2029
(Other patents)	Formulation, Process Patents (examples)	Varies (2025-2031)

Note: Expiry dates are subject to patent term adjustments and potential litigation outcomes.

What is the Market Size and Growth Potential for Vabomere?

The market for antibiotics, particularly those targeting resistant pathogens, is significant and growing due to the increasing prevalence of infections and the limited development pipeline for novel agents.

• Current Market Size: The global antibiotic market is substantial, with the market for anti-infectives for complicated urinary tract infections forming a significant segment. Precise figures for Vabomere's current sales are proprietary but industry estimates place the addressable market for carbapenem-resistant infections in the billions of dollars globally.
• Growth Drivers:
  • Rising Incidence of CRE Infections: The World Health Organization (WHO) has identified CRE as a critical priority pathogen, highlighting the urgent need for effective treatments [4]. Infections caused by CRE are associated with high mortality rates and extended hospital stays.
  • Limited Treatment Options: The pipeline for new antibiotics, especially those effective against CRE, has been historically weak. Vabomere represents one of the few available options for treating these difficult-to-treat infections.
  • Hospital Acquired Infections (HAIs): CRE are a common cause of HAIs, driving demand for effective inpatient treatments.
  • Geographic Expansion: As regulatory approvals are secured in new markets, Vabomere's sales potential expands.
• Market Size Projections: Projections for the antibiotic market, particularly for novel agents addressing resistance, are generally positive. The demand for carbapenem-sparing agents and treatments for multidrug-resistant Gram-negative bacteria is expected to continue to grow at a compound annual growth rate (CAGR) of 5-10% over the next five years, although specific figures for Vabomere are not publicly available.

What are the Competitive Threats and Generic Entry Risks?

The competitive landscape for Vabomere includes other antibiotics targeting resistant Gram-negative bacteria and the eventual entry of generic versions of Vabomere itself.

• Existing and Emerging Antibiotics:
  • Other Carbapenem-Resistant Treatments: Medications like ceftazidime-avibactam (Avycaz/Zavicefta) and imipenem-cilastatin-relebactam (Recarbrio) also target carbapenem-resistant Gram-negative infections. These products compete directly with Vabomere for market share.
  • Novel Agents in Development: The pharmaceutical pipeline includes other novel antibiotics and combinations aimed at CRE and other multidrug-resistant pathogens. Future approvals of these agents could introduce new competitive pressures.
• Generic Entry:
  • Impact of Patent Expiry: The expiry of key patents, particularly the July 2029 expiry of U.S. Patents 9,084,728 and 8,933,070, will open the door for generic manufacturers to enter the market.
  • Price Erosion: Generic competition typically leads to significant price erosion, reducing the market share and profitability of the originator product. The rate and magnitude of this erosion depend on the number of generic entrants and pricing strategies.
  • Regulatory Pathways for Generics: Generic manufacturers will seek Abbreviated New Drug Application (ANDA) approval from regulatory bodies like the U.S. Food and Drug Administration (FDA). Demonstrating bioequivalence to the reference listed drug (Vabomere) is a key requirement.
  • Exclusivity Periods and Data Exclusivity: The 5-year NCE exclusivity for vaborbactam has likely expired or will expire soon, paving the way for generic applications. However, patents and potential litigation can delay generic entry beyond the initial expiry dates.

Table 2: Key Competitors in Carbapenem-Resistant Gram-Negative Infections

Drug Name	Active Ingredients	Primary Target(s)	Status
Ceftazidime-avibactam	Ceftazidime, Avibactam	CRE (KPC, some OXA-48-like), Pseudomonas aeruginosa	Approved
Imipenem-cilastatin-relebactam	Imipenem, Cilastatin, Relebactam	CRE (KPC, some OXA-48-like), Pseudomonas aeruginosa	Approved
Plazomicin	Plazomicin	Aminoglycoside-resistant Gram-negatives, some CRE	Approved
Meropenem-vaborbactam	Meropenem, Vaborbactam	CRE (KPC, some OXA-48-like)	Approved

What is the Regulatory and Reimbursement Landscape?

Navigating the regulatory and reimbursement pathways is critical for Vabomere's commercial success and for assessing future investment potential.

• Regulatory Approvals:
  • FDA Approval: Vabomere received U.S. FDA approval on November 15, 2017, for the treatment of cUTI [2].
  • EMA Approval: Approval was granted by the European Medicines Agency (EMA) in 2019.
  • Other Jurisdictions: Approvals in other key markets are ongoing or have been secured.
• Reimbursement:
  • Payer Coverage: Reimbursement status with major commercial payers and government programs (e.g., Medicare, Medicaid in the US) is crucial. Vabomere is generally covered for its approved indications, but formulary placement and prior authorization requirements can influence utilization.
  • Value-Based Pricing: Given the high cost of treating resistant infections and the societal burden of antibiotic resistance, there is increasing interest in value-based pricing models for novel antibiotics. These models aim to align reimbursement with the demonstrated clinical and economic value of a drug.
  • Antimicrobial Stewardship Programs: Hospital formularies often implement antimicrobial stewardship programs that guide the appropriate use of antibiotics. Vabomere's narrow indication and its role against resistant pathogens are key considerations within these programs.
• Pricing: Novel antibiotics, particularly those addressing unmet medical needs, typically carry premium pricing due to the high R&D costs and limited market opportunities. Vabomere's pricing reflects its unique mechanism against CRE.

What are the Financial Performance and Investment Considerations?

Assessing the financial performance and investment landscape for Vabomere involves analyzing sales trends, profitability, and the potential impact of future market events.

• Sales Performance: Specific sales figures for Vabomere are reported by Melinta Therapeutics, its developer and marketer. As of recent filings, sales have shown growth, driven by its positioning against resistant infections. For instance, Melinta reported net sales of Vabomere of approximately $60.3 million in 2023, an increase from $44.3 million in 2022 [5].
• Profitability and R&D Investment: The development and commercialization of antibiotics are capital-intensive. Profitability is influenced by sales volumes, pricing, manufacturing costs, and ongoing R&D investments for lifecycle management or new indications.
• Market Valuation: The valuation of Melinta Therapeutics, as a company focused on infectious diseases, is influenced by the performance of its approved products, including Vabomere. Factors such as patent protection, competitive landscape, and future growth prospects are key valuation drivers.
• Investment Risks:
  • Generic Competition: The most significant risk is the impact of generic entry following patent expiry, leading to substantial price declines and market share loss.
  • Clinical Challenges: Potential for unexpected clinical findings, adverse events, or limitations in real-world effectiveness could impact uptake.
  • Reimbursement Pressures: Increasing pressure from payers to contain healthcare costs can affect pricing and access.
  • Regulatory Changes: Evolving regulatory requirements for antibiotic approval and post-market surveillance.
• Investment Opportunities:
  • Addressing Unmet Needs: Vabomere addresses a critical unmet medical need, providing a valuable therapeutic option.
  • Growing Antibiotic Market: The overall market for anti-infectives, especially for resistant pathogens, is expected to grow.
  • Potential for Lifecycle Management: Opportunities may exist for new formulations, indications, or combination therapies involving vaborbactam.
  • Acquisition Targets: Companies with successful antibiotic franchises can become attractive acquisition targets for larger pharmaceutical firms seeking to bolster their infectious disease portfolios.

Key Takeaways

Vabomere (meropenem-vaborbactam) holds a strategic position in the treatment of complicated urinary tract infections caused by carbapenem-resistant Enterobacteriaceae (CRE). Its patent protection, particularly the core composition of matter patents expiring in July 2029, is a critical factor. While facing competition from other novel agents targeting resistant Gram-negatives, the primary long-term threat is the inevitable entry of generic versions post-patent expiry. The growing incidence of CRE infections provides a strong market driver, but pharmaceutical pricing pressures and the need for effective antimicrobial stewardship programs shape its commercial trajectory. Investors must weigh the current therapeutic value and market opportunity against the predictable impact of generic erosion and ongoing R&D investment requirements inherent in antibiotic development.

Frequently Asked Questions

1. What is the primary differentiator of Vabomere compared to other carbapenem-resistant infection treatments? Vabomere's unique differentiator is its combination of meropenem with vaborbactam, a novel boronic acid-based beta-lactamase inhibitor. This specific mechanism is designed to overcome resistance conferred by certain carbapenemases, such as KPC and OXA-48-like enzymes, which are prevalent in CRE.
2. How is the market for Vabomere expected to evolve following the July 2029 patent expiry? Following the July 2029 patent expiry, the market is expected to experience significant disruption from generic competition. This will likely lead to substantial price reductions and a decrease in market share for the branded product as lower-cost generic alternatives become available.
3. Are there any approved pediatric indications for Vabomere? As of the latest available information, Vabomere is indicated for patients 18 years of age and older. Pediatric indications have not been approved.
4. What are the main challenges in the commercialization of novel antibiotics like Vabomere? Commercialization challenges include high development costs, the complexity of regulatory pathways, the need for effective reimbursement strategies, the significant threat of antibiotic resistance evolution, and the long-term market erosion caused by generic competition after patent expiry.
5. Beyond cUTI, are there other potential therapeutic areas being explored for Vabomere or its components? While cUTI is the primary approved indication, research and development into broader applications for vaborbactam-containing combinations against other types of difficult-to-treat Gram-negative infections, such as hospital-acquired pneumonia or bloodstream infections caused by CRE, may be ongoing.

Citations

[1] Melinta Therapeutics. (n.d.). Vabomere® (meropenem-vaborbactam). Retrieved from [Melinta Therapeutics Official Website - Product Information] [2] U.S. Food & Drug Administration. (2017, November 15). FDA approves new antibiotic Vabomere to treat complicated urinary tract infections. [Press Release]. [3] United States Patent and Trademark Office. (n.d.). Patent Full-Text and Image Database. (Specific patent numbers 9,084,728 and 8,933,070 accessed via USPTO search interface). [4] World Health Organization. (2020). Global priority list of antibiotic-resistant bacteria to guide research, development and public health interventions: a consensus, multicentre, report. [5] Melinta Therapeutics. (2024, March 27). Melinta Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results. [Press Release].