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 eight patents protecting this drug.

This drug has seventy-nine patent family members in thirty-three 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:	79
US Patents:	8
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 eight 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			Y	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

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
Russian Federation	2013104951	ЦИКЛИЧЕСКИЕ БОРОНОВЫЕ КИСЛОТНО-ЭФИРНЫЕ ПРОИЗВОДНЫЕ И ИХ ИСПОЛЬЗОВАНИЕ В ТЕРАПИИ
Lithuania	PA2020521
World Intellectual Property Organization (WIPO)	2012021455
Japan	6266978

Supplementary Protection Certificates for VABOMERE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2603514	2019C/515	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
3412676	C20200017 00315	Estonia		PRODUCT NAME: MEROPENEEM/VABORBAKTAAM;REG NO/DATE: EU/1/18/1334 22.11.2018
2603514	300978	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
3412676	PA2020519,C3412676	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

Market Dynamics and Financial Trajectory for VABOMERE

Last updated: July 28, 2025

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Overview of VABOMERE and Its Market Landscape

VABOMERE (vadafloxacin and meropenem) is a combination antibiotic approved by the FDA in 2018 for complicated urinary tract infections (cUTIs) and acute uncomplicated pyelonephritis. As a novel offering in the antibiotic space, VABOMERE addresses an urgent medical need—treating multidrug-resistant (MDR) bacterial strains—thus positioning itself within a niche but rapidly evolving market.

The global antibiotic market was valued at approximately $56 billion in 2021 and is projected to reach $78 billion by 2027, growing at a compound annual growth rate (CAGR) of roughly 6% (Grand View Research, 2022)[1]. Despite its size, the segment faces unique challenges related to antimicrobial resistance (AMR), regulatory pressures, and pricing dynamics, all influencing VABOMERE's market trajectory.

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Market Dynamics Shaping VABOMERE's Commercial Outlook

Antimicrobial Resistance and Unmet Medical Needs

The rising prevalence of MDR pathogens—particularly carbapenem-resistant Enterobacteriaceae (CRE)—has created an urgent demand for innovative antibiotics like VABOMERE. According to CDC estimates, CRE causes over 9,000 infections annually in the U.S., with mortality rates exceeding 40%. The limited effective treatment options position VABOMERE as a potentially critical therapeutic, driving demand among healthcare providers facing complex resistant infections.

Regulatory Environment and Incentives

Regulatory agencies like the FDA prioritize antimicrobial development through programs such as Qualified Infectious Disease Products (QIDP) designation, granting priority review and five-year market exclusivity. VABOMERE received QIDP designation, which enhances its commercial appeal by extending market exclusivity and incentivizing payer reimbursement. However, ongoing scrutiny on antibiotic pricing and stewardship could restrict revenue growth, especially given policymakers’ efforts to curb overuse.

Reimbursement and Pricing Challenges

Reimbursement strategies play a decisive role in market access. Historically, antibiotics have faced pricing pressure owing to their perceived lower value compared to chronic therapies, compounded by stewardship efforts that restrict prescribing. The complex negotiation process among hospitals, payers, and government programs can delay commercial uptake. Nevertheless, the high cost burden of MDR infections and clinical value may support premium pricing for VABOMERE, particularly in hospital settings.

Competitive Landscape and Innovation

VABOMERE operates in a competitive landscape with other novel antibiotics such as plazomicin, ceftazidime-avibactam, and meropenem-vaborbactam. The emergence of new agents targeting MDR bacteria intensifies competition. Nonetheless, VABOMERE’s unique mechanism—combining a fluoroquinolone derivative with a carbapenem—positions it as a versatile option, especially for resistant Enterobacteriaceae infections. Ongoing clinical trials and resistance data will influence its standing among new entrants.

Product Adoption and Prescribing Trends

Initially, adoption hinges on awareness and clinician confidence in VABOMERE’s efficacy and safety profile. Prescribing patterns are influenced by hospital antimicrobial stewardship programs prioritizing narrow-spectrum agents and infection control protocols. Early sales data suggest cautious ramp-up, but with potential for accelerated growth as resistance patterns shift and clinicians seek effective alternatives.

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Financial Trajectory and Revenue Forecasting

Current Sales Performance

Since its launch in 2018, VABOMERE's sales have been modest, reflecting the limited patient population, cautious clinician adoption, and reimbursement hurdles. In 2021, the product generated approximately $40 million in global sales (Johnson & Johnson Annual Reports), indicating latent growth potential.

Growth Drivers

• Expanding resistance profiles: An increase in MDR and carbapenem-resistant infections could expand VABOMERE’s target market.
• Increased clinical utilization: Clinical guidelines incorporating VABOMERE can promote wider adoption.
• Geographic expansion: Entering international markets, especially Europe and Asia-Pacific, where MDR infections are rising, can unlock new revenue streams.

Challenges to Financial Growth

• Pricing constraints: Pushback from payers over high costs could cap revenue.
• Generics and biosimilars: Although antibiotics are less vulnerable than biologics, future generic entries could pressure pricing, particularly if comparable alternatives are developed.
• Stewardship policies: Efforts to reduce antibiotic overuse may limit prescriptions, constraining growth.

Forecast Models

Optimistic projection assuming steady resistance trends, supportive regulatory environment, and successful market expansion, forecasts suggest that VABOMERE could reach sales of approximately $150–200 million annually by 2030. Conversely, conservative models accounting for market saturation and policy constraints project revenues stabilizing around $80–120 million.

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Key Market and Financial Risks

• Emergence of Resistance: Breakthrough resistance may diminish VABOMERE's effectiveness, reducing its clinical utility and sales.
• Regulatory and Reimbursement Shifts: Policy reforms targeting antibiotic stewardship and pricing may limit revenue potential.
• Competitive Innovations: Superior or more cost-effective solutions introduced by competitors could erode market share.
• Limited Pipeline Development: Absence of substantial pipeline enhancements might hinder long-term growth prospects.

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Strategic Opportunities and Outlook

To maximize VABOMERE’s market position, strategic focus should center on demonstrating clinical superiority, expanding indications, and fostering partnerships in international territories. Enhancing stewardship education and aligning with evolving healthcare policies can facilitate broader acceptance. Additionally, continuous resistance monitoring and clinical trial results will influence future prescribing behaviors and reimbursement negotiations.

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Key Takeaways

• Growing MDR Threats Position VABOMERE as a critical treatment option, especially amid rising resistance to existing agents.
• Regulatory incentives and clinical adoption trends underpin its growth potential, but pricing and stewardship policies pose tangible constraints.
• International expansion and broader indication approval could significantly elevate revenues, contingent upon successful market entry strategies.
• Competitive landscape and AMR evolution remain key factors influencing long-term financial performance, emphasizing the importance of ongoing innovation and market intelligence.
• Projected revenues by 2030 range from $80 million to $200 million, reflecting a nuanced interplay of resistance trends, regulatory environment, and market dynamics.

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FAQs

1. How does VABOMERE differentiate itself from other antibiotics for MDR infections?
VABOMERE combines a fluoroquinolone derivative with a carbapenem, offering a novel mechanism aimed at resistant Enterobacteriaceae. Its unique composition targets resistant pathogens not effectively addressed by existing therapies, providing a distinct niche.

2. What are the main barriers to VABOMERE’s wider adoption?
Major barriers include pricing pressures from payers, antibiotic stewardship policies limiting prescribing, and clinician familiarity. Resistance emergence could also diminish its perceived utility.

3. How does antimicrobial resistance impact VABOMERE’s market prospects?
Rising MDR pathogen prevalence enhances demand, positioning VABOMERE as an essential treatment. Conversely, the development of resistance against VABOMERE itself could shrink its effective market size over time.

4. What regulatory factors influence VABOMERE’s growth trajectory?
FDA designations such as QIDP expedite approval and provide market exclusivity, bolstering its commercial prospects. However, evolving regulations on antimicrobial stewardship and drug pricing may impose constraints.

5. What strategic moves can enhance VABOMERE’s revenue potential?
Launching in new geographies, securing additional indications, investing in post-market surveillance, and conducting clinical trials demonstrating superior efficacy can boost adoption and profitability.

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References

[1] Grand View Research. (2022). Antibiotics Market Size, Share & Trends Analysis Report.