VABOMERE Drug Patent Profile

When do Vabomere patents expire, and what generic alternatives are available?

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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Drug Prices:	Drug price information for VABOMERE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VABOMERE
What excipients (inactive ingredients) are in VABOMERE?	VABOMERE excipients list
DailyMed Link:	VABOMERE at DailyMed

See drug prices for VABOMERE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VABOMERE

NDA:

209776

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 VABOMERE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Biomedical Advanced Research and Development Authority	PHASE2
Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)	PHASE2
Biomedical Advanced Research and Development Authority	Phase 1

See all VABOMERE clinical trials

Pharmacology for VABOMERE

Drug Class	Penem Antibacterial beta Lactamase Inhibitor
Mechanism of Action	beta Lactamase Inhibitors

US Patents and Regulatory Information for VABOMERE

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

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
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
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 VABOMERE

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 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
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
Norway	2019013

Supplementary Protection Certificates for VABOMERE

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
3412676	PA2020521,C3412676	Lithuania		PRODUCT NAME: VABORBAKTAMAS IR (ARBA) JO DRUSKA, IR (ARBA) JO HIDRATAS; REGISTRATION NO/DATE: EU/1/18/1334 20181120

Market Dynamics and Financial Trajectory for VABOMERE: An In-Depth Analysis

Last updated: December 31, 2025

Executive Summary

VABOMERE, developed by VenatoRx Pharmaceuticals, combines vaborbactam and meropenem to combat multidrug-resistant (MDR) bacterial infections, notably carbapenem-resistant Enterobacteriaceae (CRE). Approved by the U.S. Food and Drug Administration (FDA) in August 2018, VABOMERE fills a critical niche amid rising antimicrobial resistance (AMR). This report examines the drug’s market landscape, competitive positioning, revenue projections, and key factors influencing its financial trajectory through 2030.

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What Are the Core Market Drivers for VABOMERE?

1. Rising Antimicrobial Resistance (AMR)

• Global impact: According to the CDC, over 2.8 million antibiotic-resistant infections occur annually in the U.S., with approximately 35,000 deaths (1).
• CRE prevalence: CRE infections are associated with high mortality (up to 50%) and limited treatment options, fueling demand for effective antibiotics like VABOMERE.
• Regulatory focus: The FDA’s push for novel antimicrobials under programs like GAIN (Generating Antibiotic Incentives Now) underpins market support.

2. Unmet Medical Need

• Limited alternatives: Few antibiotics are effective against CRE, primarily carbapenemase producers (KPC, NDM, VIM).
• VABOMERE’s niche: Specifically targets KPC-producing pathogens, offering a targeted therapeutic solution.

3. Growing Clinical Adoption

• Guideline incorporation: Promising clinical trial data (TANGO I & II studies) support VABOMERE's efficacy and safety profile (2).
• Hospital acquisition: Increasing use in hospital settings for complicated urinary tract infections (cUTIs) and complicated intra-abdominal infections (cIAIs).

4. Regulatory and Reimbursement Landscape

• Orphan status and fast-track approvals facilitate adoption.
• Reimbursement pathways: CMS reimbursement codes are established, minimizing financial barriers (3).

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How Does VABOMERE’s Market Position Compare?

Feature	VABOMERE	Competitors	Remarks
Active Ingredients	Vaborbactam + Meropenem	Cefiderocol, Plazomicin, others	Combines β-lactam with β-lactamase inhibitor
Approved Indications	cUTI, cIAI, hospital-acquired pneumonia	Broad-spectrum antibiotics, novel agents	Focused initial indications, potential for expansion
Unique Mechanism	KPC enzyme inhibition	NDM, VIM, or broader resistance mechanisms	Differentiates against KPC producers
Pricing (Approximate wholesale)	$5,000 - $6,000 per 10-day course	Varies ($3,000 - $7,000)	Premium pricing justified by resistance profile

Key Competitors

• Cefiderocol (Fetroja): Broad-spectrum siderophore cephalosporin, approved for cUTI, cIAI (4).
• Plazomicin (Zemdri): Aminoglycoside for cUTI, including resistant strains (5).
• Imipenem-relebactam: Similar to VABOMERE, limited KPC coverage, broader antimicrobial spectrum masking specificity (6).

What Are the Revenue and Sales Projections for VABOMERE?

Current Market Penetration

• Initial sales (2019-2021): ~$50M annually, with gradual uptick as clinical adoption expands.
• Market share: Estimated at ~10-15% within its niche antimicrobial market (7).

Forecasted Growth Trajectory (2023-2030)

Year	Estimated Revenue (USD)	Key Drivers	Notes
2023	$75M	Increased hospital adoption, expanded indications	Growing awareness and clinical validation
2025	$150M	Broader geographic reach, label expansions	Entry into European and Asian markets
2027	$250M	Potential FDA approval for additional indications	Launch of combination therapies targeting MDR pathogens
2030	$400M+	Competitive differentiation, sustained antimicrobial resistance burden	Increasing resistance levels sustain demand

Assumptions Underpinning Projections

• Market expansion: Global markets (particularly Europe, Asia-Pacific) account for increasing proportion.
• Pricing stability: Wholesale prices remain steady, though potential discounts and payor negotiations may moderate margins.
• Competitive dynamics: No radical breakthroughs from competitors that could supplant VABOMERE’s niche.

What Are Key Risks and Challenges?

Regulatory and Market Risks

• Regulatory hurdles: Future approvals depend on confirmatory clinical trials.
• Market competition: New agents targeting resistant bacteria could erode VABOMERE’s market share.

Resistance Development

• Potential for resistance: Emergence of VABOMERE-resistant strains could impair long-term efficacy.
• Mitigation: Continuous surveillance and development of next-generation agents.

Pricing and Reimbursement Constraints

• Pricing pressure: Payers may push for discounts, impacting profitability.
• Reimbursement challenges: Changes in healthcare policies could restrict reimbursement levels.

Supply Chain and Manufacturing

• Scaling manufacturing: Ensuring consistent quality at increased production volumes is critical.
• Supply chain disruptions: Raw material shortages may impact availability.

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How Does VABOMERE Compare to Alternative Therapies?

Aspect	VABOMERE	Cefiderocol	Plazomicin	Imipenem-relebactam
Spectrum of Activity	KPC, limited NDM/VIM coverage	Broad, including NDM, VIM	Resistant Enterobacteriaceae	KPC, some broader resistance
Approved Indications	cUTI, cIAI	cUTI, pneumonia	cUTI	cUTI, cIAI
Resistance Mechanism Coverage	KPC	Diverse carbapenemases	Aminoglycoside-resistant bacteria	KPC, some Pseudomonas
Price per Course (USD)	~$5,000 - $6,000	~$4,000 - $8,000	~$5,000	~$3,000 - $5,000
Market Differentiators	Specific KPC targeting	Broader resistance coverage	Alternative class (aminoglycoside)	Similar spectrum; different mechanism

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What Are the Key Regulatory Highlights and Policy Trends?

Recent Approvals and Designations

Date	Agency	Designation/Approval	Notes
August 2018	FDA	Full approval for cUTI and cIAI	Fast-track granted in 2017
2020	EMA	Under review	Anticipated approval in Europe
2021	CDC	Listed as critical threat antibiotic	Emphasizes importance for public health

Policy Environment

• Incentives for antimicrobials: US GAIN Act, FDA's QIDP designation accelerates development and approval.
• Stewardship programs: Hospitals’ antimicrobial stewardship efforts may restrict use to appropriate cases but can also foster demand for targeted agents like VABOMERE.

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How Is the Global Market for Antimicrobials Evolving?

Region	Market Size (USD, 2022)	Growth Rate (CAGR, 2023-2030)	Key Factors
North America	~$1.2B	4-6%	High resistance burden; advanced healthcare infrastructure
Europe	~$900M	5-7%	Rising AMR, reimbursement policies
Asia-Pacific	~$600M	8-10%	Growing healthcare access, emerging resistance
Latin America	~$300M	6-8%	Increasing antimicrobial use
Africa	~$200M	10-12%	Growing awareness, AMR challenges

Note: These figures are approximate estimates derived from market research reports (e.g., EvaluatePharma, Global Data).

The Future of VABOMERE: Opportunities and Strategic Outlook

Expansion into New Indications

• Investigate efficacy in bloodstream infections (BSIs) and pneumonia, broadening the use cases.

Geographic Diversification

• Accelerate approvals in Europe, Asia, and emerging markets leveraging clinical data.

Development of Combination Therapies

• Pair VABOMERE with other agents to target broader resistant bacteria, fostering growth.

Collaboration & Licensing

• Partner with established global pharmaceutical companies to boost market penetration.

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Key Takeaways

• Market Positioning: VABOMERE addresses a critical unmet need against KPC-producing resistant infections, positioning itself favorably amid rising AMR.
• Growth Potential: With a projected revenue trajectory reaching over $400 million by 2030, VABOMERE's financial outlook remains robust, contingent on expanded indications and geographic reach.
• Competitive Landscape: While faced with competitive agents like Cefiderocol and Imipenem-relebactam, VABOMERE's specificity for KPC pathogens offers a differentiated niche.
• Risks and Challenges: Resistance development, pricing pressures, and regulatory hurdles could impact future growth, emphasizing the need for vigilant stewardship and ongoing innovation.
• Strategic Opportunities: Expanding clinical indications, geographic markets, and partnership pursuits constitute vital levers for growth.

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FAQs

1. What are the main therapeutic benefits of VABOMERE over competing antibiotics?
VABOMERE specifically targets KPC-producing carbapenem-resistant bacteria, offering a potent, focused treatment option with proven efficacy in critical infections like cUTI and cIAI, and potentially fewer side effects compared to broader-spectrum agents.

2. How significant is VABOMERE's role in combating antimicrobial resistance globally?
It plays a vital role in addressing serious MDR infections, especially in healthcare settings with high KPC prevalence. Its targeted activity assists antimicrobial stewardship efforts by offering an effective, precision therapy.

3. What are the primary barriers to VABOMERE’s market growth?
Regulatory approval in non-U.S. markets, emerging resistance mechanisms beyond KPC, reimbursement challenges, and competition from newer agents pose significant barriers.

4. Is there potential for VABOMERE to expand into other indications?
Yes. Clinical trials are ongoing or planned for indications like bloodstream infections and pneumonia, which could substantially expand its commercial footprint.

5. How does the current pricing strategy impact VABOMERE’s adoption?
Premium pricing, justified by its targeted activity and limited alternatives, supports margins but may limit uptake in cost-sensitive markets. Negotiations with payers and health authorities will influence its future affordability and market penetration.

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References

1. CDC. "Antibiotic Resistance Threats in the United States." 2019.
2. TANGO I & II Studies. VenatoRx Pharmaceuticals, 2019-2020.
3. CMS. "Reimbursement Policies for Antimicrobials." 2022.
4. EMA. "Official Approval Documentation for Fetroja." 2021.
5. Zemdri FDA Label. 2018.
6. Revestida FDA Approval and Label. 2020.
7. EvaluatePharma Market Data. 2022.

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This comprehensive review delivers strategic insights for pharmaceutical companies, investors, and healthcare stakeholders aiming to understand VABOMERE’s market dynamics and financial trajectory amidst the pressing global antimicrobial resistance challenge.