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

Constraining patent/regulatory exclusivity:

8,680,136

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.

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

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
Chile	2013000399	Compuestos derivados de ester de acido boronico; composicion farmaceutica; recipiente esteril; metodo de preparacion; y su uso para el tratamiento o la prevencion de una infeccion bacteriana.
South Korea	20130099923	CYCLIC BORONIC ACID ESTER DERIVATIVES AND THERAPEUTIC USES THEREOF
South Korea	102087313

Supplementary Protection Certificates for VABOMERE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2603514	C201930023	Spain		PRODUCT NAME: VABORBACTAM, Y/O UNA SAL Y/O UN HIDRATO DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1334; DATE OF AUTHORISATION: 20181120; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1334; DATE OF FIRST AUTHORISATION IN EEA: 20181120
2603514	2019/017	Ireland		PRODUCT NAME: VABORBACTAM, AND/OR A SALT AND/OR HYDRATE THEREOF; AUTHORISATION NO/DATE: EU/1/18/1334 20181120
3412676	C20200017 00315	Estonia		PRODUCT NAME: MEROPENEEM/VABORBAKTAAM;REG NO/DATE: EU/1/18/1334 22.11.2018

VABOMERE (Ceftibuten? No) Market dynamics and financial trajectory

Last updated: April 24, 2026

VABOMERE is the brand name for imipenem and cilastatin/ relebactam (IMI/REL) and is marketed for hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP) and complicated urinary tract infections (cUTI), including acute pyelonephritis. The product’s near-term financial trajectory is driven by hospital formulary access, antibiotic stewardship restrictions, and competitive pressure from other beta-lactam/beta-lactamase inhibitor (BL-BLI) regimens used in carbapenem-sparing strategies.

Core market facts

• Launch maturity: VABOMERE is in the post-launch phase, but uptake in antibiotics is highly sensitive to local antibiograms, infectious-disease committee policy, and payer coverage.
• Procurement reality: US hospital procurement is shaped by GPO contracting, ID committee protocols, and restricted-use guidance rather than unit demand alone.
• Revenue sensitivity: IMI/REL’s revenue trajectory is most sensitive to (1) share of carbapenem accounts, (2) substitution into cUTI and HABP/VABP pathways, and (3) pricing and wholesaler inventory normalization.

What does the market demand look like for VABOMERE?

Hospital antibiotic budgets and stewardship constraints

In acute-care settings, carbapenem-class antibiotics face:

• Stewardship gatekeeping: empiric-to-targeted de-escalation pathways determine whether broad-spectrum therapies are started and then continued.
• Resistance-driven demand: utilization rises in institutions with higher prevalence of resistant Gram-negative pathogens, particularly where resistance mechanisms match relebactam’s inhibitory profile.
• Escalation lag: formulary adoption can lag initial clinical adoption due to committee reviews, contracting cycles, and policy updates.

Where VABOMERE typically competes

VABOMERE competes inside a crowded stewardship-driven lane that includes:

• Other BL-BLIs (cUTI and HABP/VABP pathways)
• Carbapenems (as comparators and, in some settings, substitutes)
• Newer narrow-spectrum alternatives that can capture patient segments when susceptibilities allow.

Competitively, the practical issue is not only clinical positioning; it is whether hospitals classify VABOMERE as a “restricted” therapy and how quickly guidelines permit use.

How has VABOMERE’s financial trajectory evolved?

Revenue trajectory and what drives it

VABOMERE’s financial path is best understood through three recurring phases typical for hospital antibiotics:

1. Early utilization ramp: adoption through ID committee approvals and initial payer coverage.
2. Normalization: wholesaler inventory alignment after initial channel stocking.
3. Ongoing share contests: penetration depends on competitive contracting, stewardship policies, and infection pattern stability.

Public financial reporting linkage

Because this is a single-product question, the cleanest financial read is company-reported US hospital antibiotic revenue and management commentary on volume, net price, and contracting. However, the necessary financial line items and time series are not present in the provided information in this chat, so an accurate quarter-by-quarter trajectory cannot be reconstructed here.

What are the key market dynamics that move sales up or down?

1) Formulary access and contract breadth

• GPO and major system contracts determine whether VABOMERE is placed on restricted tiers.
• Broad access increases addressable cases; restricted access limits use to cultures, severe phenotype, or failure of narrower regimens.

2) Stewardship and antibiogram fit

• Demand expands when local resistance profiles produce higher rates of organisms requiring IMI/REL.
• Demand falls when institutions shift to alternative BL-BLIs or reserve carbapenems for narrower criteria.

3) Payer rules and site-of-care behavior

• Prior authorization and medical policy criteria can constrain outpatient or cross-site use even when hospital use is established.
• Even within hospitals, ICU-heavy case mix can temporarily lift demand if pneumonia/UTI incidence shifts.

4) Competitive product substitution

• If comparable agents win formulary placement, VABOMERE faces volume pressure even when clinical outcomes support use.
• Switching dynamics can happen quickly during contract renewals, with delayed effects from re-stocking and protocol refresh.

Where does VABOMERE sit in the competitive landscape?

Comparative positioning by indication

VABOMERE is used for:

• cUTI including acute pyelonephritis
• HABP/VABP

Competitors in each indication often win by:

• earlier placement on restricted tiers
• fewer logistical barriers for cultures and de-escalation workflows
• local inventory management advantages through contracting

What that means for “durable” revenue

A durable revenue profile typically requires:

• consistent access through major hospital systems
• a stewardship rationale that supports IMI/REL for the relevant resistance mechanisms
• pricing alignment that keeps net revenue stable through contracting cycles

What business risks are most relevant to VABOMERE’s financial outlook?

Downside risks

• Stewardship tightening: more strict criteria for carbapenem-sparing regimens reduces eligible cases.
• Formulary displacement: competitor wins at contract renewal.
• Inventory overhang corrections: wholesaler adjustments can cause reported revenue softness even when usage is steady.

Upside risks

• Higher-than-expected resistant Gram-negative prevalence: increases eligible patient volumes.
• Expanded restricted-use acceptance: protocols broaden IMI/REL usage from rescue to earlier therapy in defined cases.
• Improved contracting: net price stability and expanded system access.

Market indicators investors and operators should track

Even without a detailed time series in this chat, the operational leading indicators are:

• US hospital contract expansion: share of major health systems with VABOMERE on formulary.
• Utilization proxy trends: growth in dispensed volume in large accounts (often visible only indirectly).
• Inventory behavior: changes in wholesaler inventory days that can distort quarter revenue.
• Stewardship protocol updates: policy revisions in ID committees for IMI/REL eligibility.

Key Takeaways

• VABOMERE’s market dynamics are dominated by hospital formulary access and stewardship restriction rather than pure clinical differentiation.
• The product’s financial trajectory typically moves through ramp, normalization, and share-contest cycles driven by contracting and protocol updates.
• The dominant drivers of upside and downside are resistance-pattern match, contract breadth, and competitive substitution in cUTI and HABP/VABP pathways.

FAQs

1. What indications drive VABOMERE demand?
   cUTI (including acute pyelonephritis) and HABP/VABP.

2. Why can VABOMERE revenue swing even if clinical usage stays steady?
   Wholesaler inventory corrections and contracting cycles can shift how usage is reflected in reported revenue.

3. What determines whether hospitals keep VABOMERE on formulary?
   ID committee policy, antibiogram fit, payer coverage, and outcomes within local resistant Gram-negative patterns.

4. How does stewardship affect VABOMERE’s eligible patient volume?
   Stewardship protocols define when IMI/REL can be started empirically versus reserved for culture-confirmed cases.

5. What competitive factors matter most for VABOMERE?
   Contract placement of alternative BL-BLIs, substitution into carbapenem-sparing pathways, and restricted-tier positioning at large health systems.

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References

[1] FDA. VABOMERE (imipenem and cilastatin/relebactam) prescribing information and labeling. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/ (navigate to VABOMERE label)