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.

The generic ingredient in VABOMERE is meropenem; vaborbactam. There is one drug master file entry 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

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

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
Australia	2011289615
Brazil	112013003045
Canada	2807546
Chile	2013000399

Supplementary Protection Certificates for VABOMERE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2603514	300977	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2603514	300978	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2603514	122019000027	Germany		PREVIOUS REPRESENTATIVE: ABITZ & PARTNER PATENTANWAELTE MBB, 81925 MUENCHEN, DE; PRODUCT NAME: KOMBINATION VON VABORBACTAM, UND/ODER EIN SALZ UND/ODER EIN HYDRAT DAVON, UND MEROPENEM, UND/ODER EIN SALZ UND/ODER EIN HYDRAT DAVON, INSBESONDERE MEROPENEMTRIHYDRAT; AUTHORISATION NO/DATE: EU/1/18/1334 20181120
2603514	CA 2019 00015	Denmark		PRODUCT NAME: EN KOMBINATION AF VABORBACTAM, OG/ELLER ET SALT OG/ELLER HYDRAT DERAF, OG MEROPENEM, OG/ELLER ET SALT OG/ELLER HYDRAT DERAF, SAERLIGT MEROPENEM TRIHYDRAT; REG. NO/DATE: EU/1/18/1334 20181122

Vabomere Market Dynamics, Patent Exclusivity, Competitive Position, and Financial Trajectory

Last updated: September 23, 2026

Vabomere, the fixed-dose combination of meropenem and vaborbactam, is a hospital-focused antibiotic marketed by Melinta Therapeutics. Its commercial value depends on carbapenem-resistant Enterobacterales infections, formulary access, antimicrobial-stewardship controls, and hospital purchasing rather than broad outpatient volume.

The product has a differentiated clinical position against KPC-producing carbapenem-resistant organisms, but its market is constrained by restricted use, competing beta-lactam/beta-lactamase inhibitor products, limited pathogen prevalence, and weak public visibility into product-level revenue. Vabomere has no biosimilar pathway, while generic entry would require an abbreviated new drug application for a complex injectable combination and would face formulation, analytical, clinical, and patent barriers.

What is Vabomere and how does it work?

Vabomere combines meropenem, a carbapenem antibiotic, with vaborbactam, a cyclic boronic acid beta-lactamase inhibitor. The product is administered intravenously and is approved for adults with complicated urinary tract infections, including pyelonephritis, and for hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible organisms [1].

Vaborbactam inhibits class A serine beta-lactamases, including Klebsiella pneumoniae carbapenemases, or KPC enzymes. It does not reliably inhibit metallo-beta-lactamases such as NDM, VIM, or IMP enzymes, and it does not provide dependable activity against class D OXA-48-like carbapenemases.

Attribute	Vabomere
Active ingredients	Meropenem and vaborbactam
Dosage form	Intravenous powder for reconstitution
FDA application	NDA 209776
Initial U.S. approval	August 29, 2017
Primary target	Carbapenem-resistant Enterobacterales, particularly KPC-producing strains
Initial indication	Complicated urinary tract infections and pyelonephritis
Expanded indication	Hospital-acquired and ventilator-associated bacterial pneumonia
Commercial sponsor	Melinta Therapeutics
Biosimilar exposure	None
Primary substitutes	Avycaz, Fetroja, Recarbrio, cefiderocol, polymyxins, aminoglycosides, and salvage regimens

The U.S. label requires renal-dose adjustment. This limits use in patients with impaired kidney function but also gives hospitals a defined dosing framework for a high-acuity population [1].

How large is the Vabomere market?

Vabomere operates in the narrow market for hospital antibiotics used against multidrug-resistant Gram-negative infections. Market growth is driven by resistance, while utilization is deliberately controlled by stewardship programs.

The main demand drivers are:

• Rising incidence of carbapenem-resistant Enterobacterales.
• Increased hospital testing for resistance mechanisms.
• Infectious-disease specialist preference for targeted therapy.
• Need to reduce reliance on polymyxins and toxic salvage regimens.
• Use in intensive-care and immunocompromised populations.
• Hospital protocols favoring newer agents when KPC production is suspected or confirmed.

The main constraints are:

• Low overall incidence relative to common bacterial infections.
• Restricted hospital formulary placement.
• Short treatment courses compared with chronic medicines.
• Stewardship rules that limit empiric use.
• Competition from other beta-lactam/beta-lactamase inhibitor combinations.
• Use of older generic carbapenems when organisms remain susceptible.
• Budget controls imposed by group purchasing organizations and hospital systems.

Vabomere is therefore a high-value, low-volume product. Its commercial performance is more sensitive to formulary wins, microbiology results, and resistance trends than to broad prescription growth.

Who competes with Vabomere?

Vabomere competes most directly with Avycaz and Recarbrio. Fetroja competes in a partially overlapping segment but has a different resistance profile and clinical positioning.

Product	Active ingredients	Principal strength	Key limitation
Vabomere	Meropenem/vaborbactam	Strong activity against KPC-producing organisms; carbapenem backbone	Limited activity against metallo-beta-lactamases and many OXA-48-like enzymes
Avycaz	Ceftazidime/avibactam	Broad activity against KPC and OXA-48-like enzymes	Resistance can emerge through KPC mutations; not active against metallo-beta-lactamases
Recarbrio	Imipenem/cilastatin/relebactam	Activity against selected KPC-producing organisms and Pseudomonas	More limited fit for certain resistant Enterobacterales than Vabomere
Fetroja	Cefiderocol	Activity against many metallo-beta-lactamase-producing organisms	Clinical positioning and safety concerns vary by infection type
Polymyxins	Colistin or polymyxin B	Low-cost salvage option	Nephrotoxicity and neurotoxicity
Generic carbapenems	Meropenem, imipenem/cilastatin	Low acquisition cost and broad availability	Ineffective against many carbapenemase-producing organisms

Vabomere’s clearest competitive advantage is its combination of a familiar carbapenem backbone with vaborbactam’s KPC activity. Avycaz has a broader beta-lactamase profile in some settings, while Fetroja is more relevant when metallo-beta-lactamases are suspected.

What is Vabomere’s FDA regulatory status?

The FDA approved Vabomere in 2017 for complicated urinary tract infections and pyelonephritis. The approval was supported by the TANGO-I trial, which evaluated meropenem-vaborbactam against piperacillin/tazobactam. The product later received approval for hospital-acquired and ventilator-associated bacterial pneumonia based on the TANGO II program and supporting evidence [1, 2].

The product carries the regulatory profile of a high-priority hospital anti-infective:

• Intravenous administration.
• Use directed by susceptibility testing.
• Renal-dose adjustment.
• Label limitations tied to resistant Gram-negative pathogens.
• No outpatient oral formulation.
• No pediatric commercial expansion comparable to mass-market antibiotics.

The product’s regulatory value is linked to the limited number of effective therapies for resistant organisms. That value does not translate into high prescription volume because hospitals reserve the medicine for patients with documented or strongly suspected resistant infections.

What patents protect Vabomere?

Vabomere is protected through a combination of compound, combination, formulation, dosing, and treatment-related intellectual property. The relevant estate is more important for delaying generic competition than for creating a long-term monopoly over meropenem itself, which is an old generic antibiotic.

The principal protection categories include:

1. Vaborbactam composition-of-matter rights.
2. Meropenem-vaborbactam combination claims.
3. Injectable pharmaceutical compositions.
4. Stabilized formulations and reconstitution technology.
5. Dosing regimens for renal impairment.
6. Treatment of infections caused by beta-lactamase-producing organisms.
7. Manufacturing and purification processes.

U.S. patent records associated with Vabomere have included patents in the U.S. 9 million, 10 million, and 11 million series covering vaborbactam, meropenem-vaborbactam combinations, and related pharmaceutical uses. The exact Orange Book listing and expiration analysis must be based on the current FDA Orange Book record for NDA 209776, because listed patents and pediatric extensions can change over time [3].

What is the Orange Book status of Vabomere?

Vabomere is an FDA-approved small-molecule injectable product listed under NDA 209776. It is not a biologic and therefore does not use the Biologics Price Competition and Innovation Act pathway.

The commercial patent question is whether a generic applicant can:

• File an ANDA with a Paragraph IV certification.
• Avoid an active listed patent through a Paragraph III certification.
• Carve out patented methods of use.
• Demonstrate pharmaceutical equivalence for the fixed-dose injectable combination.
• Resolve formulation and manufacturing differences through FDA review.

The expected generic pathway is more difficult than a conventional oral tablet because the applicant must reproduce a sterile injectable combination with compatible stability, matching strength, container-closure performance, and validated analytical methods.

When does Vabomere lose exclusivity?

Vabomere’s regulatory exclusivity is separate from patent exclusivity.

The product received approval in 2017, so its standard new chemical entity exclusivity period has expired. Any orphan-drug exclusivity or other statutory exclusivity would depend on the specific FDA designation and indication record. The principal remaining barrier has therefore been patent protection and the technical complexity of the injectable combination.

A practical loss-of-exclusivity timeline is:

Period	Commercial significance
2017	Initial U.S. approval for complicated urinary tract infections
2018-2019	Early hospital adoption and expansion of antimicrobial-stewardship use
2020	Expansion to hospital-acquired and ventilator-associated bacterial pneumonia
2022 onward	Greater exposure to generic and formulary substitution analysis as core regulatory exclusivity aged
2024 onward	Patent and ANDA litigation risk becomes more material if a generic applicant files a Paragraph IV certification
Post-patent expiry	Potential generic entry, subject to FDA approval, patent litigation, settlements, and manufacturing readiness

The earliest commercially relevant loss-of-exclusivity date should not be treated as the expiration date of a single composition patent. Combination, formulation, and method-of-use patents can produce different dates. A generic applicant may also launch at risk after litigation milestones, although hospital purchasing contracts and supply reliability would affect actual uptake.

Have companies filed Paragraph IV challenges against Vabomere?

Publicly visible information through mid-2024 did not establish a major, broadly reported Paragraph IV litigation campaign against Vabomere comparable to the litigation surrounding large primary-care products.

That does not eliminate challenge risk. A generic applicant can file an ANDA with a Paragraph IV certification without a public commercial launch. The absence of widely reported litigation is consistent with several factors:

• Small market size relative to the cost of sterile injectable development.
• Technical complexity in manufacturing and stability testing.
• Uncertainty over hospital purchasing volumes.
• Multiple patent layers with different expiration dates.
• Limited return on investment for a first generic entrant.
• Potential difficulty achieving rapid formulary substitution for a restricted-use antibiotic.

A first generic entrant would likely face a high-value but narrow market. A second entrant could materially reduce prices if the product becomes substitutable under hospital purchasing contracts.

What is Vabomere’s financial trajectory?

Melinta is a private company and has not provided a consistent public series of Vabomere net sales comparable to a publicly traded pharmaceutical company. Product-level revenue is therefore less transparent than for drugs marketed by Merck, Pfizer, or AbbVie.

The financial trajectory can be characterized as follows:

2017-2019: Launch and controlled adoption

The Medicines Company launched Vabomere after FDA approval. Early uptake was limited by hospital approval processes, diagnostic delays, and the need to establish clinical preference against older therapies. The company later sold or transferred commercial assets as part of broader corporate transactions involving Melinta.

2019-2021: Portfolio integration

Melinta acquired a portfolio that included Vabomere and other hospital products. The company’s commercial model centered on specialty and acute-care medicines rather than large primary-care markets. Vabomere benefited from a broader hospital sales infrastructure but remained exposed to the company’s financial restructuring and private-equity ownership changes.

2021 onward: Mature hospital product

Vabomere’s revenue opportunity became dependent on resistant-infection incidence, hospital access, and price discipline. The product’s second indication expanded its addressable population, but pneumonia treatment is clinically competitive and often governed by local resistance patterns.

The financial profile is likely characterized by high gross margin relative to manufacturing cost, offset by:

• Small patient volume.
• High hospital contracting costs.
• Specialty sales infrastructure.
• Pharmacovigilance and medical-affairs spending.
• Discounting to secure formulary access.
• Inventory and supply requirements for an injectable hospital product.

Vabomere’s value to Melinta is strategic as well as financial. A hospital antibiotic portfolio can support bundled contracting, infectious-disease account access, and cross-selling of complementary products. Product-level profitability cannot be reliably calculated from public disclosures because Melinta does not report audited Vabomere revenue, gross margin, or operating income separately.

What licensing and ownership transactions affect Vabomere?

Vabomere originated from the antibiotic-development platform associated with Rempex Pharmaceuticals. The Medicines Company acquired Rempex in 2015, obtaining vaborbactam-related assets and other anti-infective programs. Melinta later acquired The Medicines Company’s infectious-disease portfolio, including Vabomere, as part of its expansion into hospital antibiotics [4, 5].

The ownership chain matters because patent prosecution, litigation control, manufacturing rights, and commercial obligations may be distributed across predecessor entities, affiliates, and contract manufacturers. The commercial sponsor is Melinta, but the patent record may identify predecessor applicants or related corporate entities.

How strong is the Vabomere patent estate?

Vabomere has a moderately strong commercial patent position but a narrower strategic moat than a novel oral drug with a single dominant composition patent.

Strengths include:

• Combination-product claims tied to a specific resistant-pathogen use.
• Injectable formulation complexity.
• Specialized manufacturing requirements.
• Hospital switching friction.
• Limited supplier base.
• Clinical importance in KPC infections.

Weaknesses include:

• Meropenem is long generic.
• Vaborbactam is administered with a known antibiotic backbone.
• Hospital buyers are price-sensitive.
• A generic applicant may challenge individual patents sequentially.
• Competing products address overlapping infections.
• Stewardship limits volume growth even during patent protection.

The estate is strongest against rapid generic substitution, not against therapeutic competition. Avycaz, Recarbrio, and Fetroja can capture demand without infringing Vabomere patents.

What generic launch risks exist for Vabomere?

A generic launch would likely proceed in stages:

1. An ANDA applicant files with Paragraph IV certifications.
2. The patent holder initiates litigation within the statutory window.
3. FDA approval may be delayed by the 30-month stay, subject to litigation developments.
4. The parties may settle with an agreed launch date.
5. The generic launches initially through selected hospital accounts.
6. Additional entrants create price erosion and contracting pressure.

The commercial impact would depend on whether the first entrant receives 180-day exclusivity, whether the generic is therapeutically substitutable at the hospital level, and whether the reference product maintains preferred status for resistant infections.

A first generic could cause a sharper price reduction than volume loss. Hospitals may continue to carry branded Vabomere for protocol reasons, especially where microbiology teams prefer the reference product or where supply continuity matters.

What geographic markets are most important for Vabomere?

The United States is the principal commercial market because of its high concentration of advanced hospitals, infectious-disease specialists, antimicrobial-stewardship programs, and documented KPC epidemiology.

International opportunities are more fragmented:

• Europe has country-specific hospital procurement.
• Resistance mechanisms vary significantly by geography.
• Reimbursement and tender systems can compress price.
• Some regions have greater prevalence of NDM or OXA-48-like enzymes, where Vabomere may be less suitable.
• Emerging markets may have high resistance but limited ability to pay for newer intravenous agents.

The product’s geographic value is therefore highest where KPC prevalence, diagnostic capability, and hospital purchasing budgets align.

How does Vabomere compare with Avycaz and Fetroja?

Vabomere is best positioned when KPC-producing Enterobacterales are suspected or confirmed and a carbapenem-based regimen is clinically appropriate. Avycaz may be preferred when OXA-48-like enzymes are a concern. Fetroja has greater relevance for metallo-beta-lactamase-producing organisms, although treatment selection depends on susceptibility, infection site, patient factors, and guideline recommendations [6].

The products do not compete solely on price. Hospitals evaluate local antibiograms, resistance mechanisms, mortality data, renal dosing, adverse events, microbiology turnaround time, and infectious-disease physician preference.

Key Takeaways

• Vabomere is a hospital anti-infective combining meropenem and vaborbactam.
• Its core commercial value is activity against KPC-producing carbapenem-resistant Enterobacterales.
• The market is high value but low volume because antimicrobial stewardship limits use.
• Avycaz, Recarbrio, and Fetroja are the principal branded competitors.
• Vabomere is a small-molecule injectable product, not a biologic, so biosimilar risk does not apply.
• The patent estate covers vaborbactam, meropenem-vaborbactam combinations, formulations, dosing, treatment methods, and manufacturing.
• Core regulatory exclusivity has aged, making patent and ANDA strategy increasingly important.
• Public disclosures do not provide a consistent current product-level revenue series.
• Generic entry is technically and commercially more difficult than for a standard oral antibiotic.
• The strongest long-term risks are therapeutic competition, hospital pricing pressure, and limited treatment volume.

FAQs About Vabomere Market and Patent Risk

Is Vabomere a blockbuster drug?

No. Vabomere addresses a narrow hospital market and has not been publicly reported as a blockbuster product. Its strategic value is greater than its likely absolute sales contribution because it supports Melinta’s hospital anti-infective portfolio.

Is there a generic version of Vabomere?

No widely established generic version had displaced the branded product in the U.S. public market through mid-2024. Any entrant would need FDA approval for the fixed-dose sterile injectable combination.

Can Vabomere treat NDM-producing bacteria?

Vabomere is not reliably active against NDM and other metallo-beta-lactamases. Treatment should follow susceptibility testing and applicable infectious-disease guidance.

Does Vabomere have biosimilar competition?

No. Vabomere is a chemically synthesized small-molecule drug, so competition would proceed through the ANDA generic-drug pathway rather than biosimilar approval.

Which company owns Vabomere?

Melinta Therapeutics is the commercial sponsor associated with Vabomere in the United States. The product originated from the Rempex antibiotic-development portfolio and passed through The Medicines Company before reaching Melinta.

References

1. U.S. Food and Drug Administration. (2024). Vabomere prescribing information.
2. Wunderink, R. G., Giamarellos-Bourboulis, E. J., Rahav, G., et al. (2018). Effect and safety of meropenem-vaborbactam versus best-available therapy in patients with carbapenem-resistant Enterobacteriaceae infections. Clinical Infectious Diseases, 68(4), 622-629.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
4. The Medicines Company. (2015). The Medicines Company completes acquisition of Rempex Pharmaceuticals.
5. Melinta Therapeutics. (2019). Melinta completes acquisition of The Medicines Company’s infectious disease portfolio.
6. Infectious Diseases Society of America. (2024). IDSA guidance on the treatment of antimicrobial-resistant Gram-negative infections.

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