RECARBRIO Drug Patent Profile

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Which patents cover Recarbrio, and what generic alternatives are available?

Recarbrio is a drug marketed by Msd Merck Co and is included in one NDA. There is one patent protecting this drug.

The generic ingredient in RECARBRIO is cilastatin sodium; imipenem; relebactam. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cilastatin sodium; imipenem; relebactam profile page.

DrugPatentWatch^® Generic Entry Outlook for Recarbrio

Recarbrio was eligible for patent challenges on July 16, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 16, 2029. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for RECARBRIO

US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	5
Drug Prices:	Drug price information for RECARBRIO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RECARBRIO
What excipients (inactive ingredients) are in RECARBRIO?	RECARBRIO excipients list
DailyMed Link:	RECARBRIO at DailyMed

See drug prices for RECARBRIO

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

NDA:

212819

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 RECARBRIO

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

Sponsor	Phase
Merck Sharp & Dohme LLC	Phase 4
Hartford Hospital	Phase 4
Connecticut Children's Medical Center	Phase 4

See all RECARBRIO clinical trials

Pharmacology for RECARBRIO

Drug Class	Penem Antibacterial Renal Dehydropeptidase Inhibitor beta Lactamase Inhibitor
Mechanism of Action	Dipeptidase Inhibitors beta Lactamase Inhibitors

US Patents and Regulatory Information for RECARBRIO

RECARBRIO is protected by three US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.

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
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		DISCN	Yes	No			Y	Y
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		DISCN	Yes	No
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		DISCN	Yes	No

International Patents for RECARBRIO

When does loss-of-exclusivity occur for RECARBRIO?

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

Australia

Brazil

Canada

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

European Patent Office

Finland

France

Honduras

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Nicaragua

Norway

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Africa

South Korea

Spain

Ukraine

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 RECARBRIO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2009206119
Brazil	PI0906871
Canada	2712783

Supplementary Protection Certificates for RECARBRIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2231667	301050	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
2666774	301052	Netherlands		PRODUCT NAME: RELEBACTAM, DESGEWENST IN DE VORM VAN HET MONOHYDRAAT, IMIPENEM EN CILASTATINE, DESGEWENST IN DE VORM VAN HET NATRIUMZOUT; REGISTRATION NO/DATE: EU/1/19/1420 20200217
2666774	301051	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE

RECARBRIO Market Dynamics, Financial Trajectory, Patent Position, and Generic Entry Risk

Last updated: October 23, 2026

RECARBRIO, Merck’s imipenem/cilastatin/relebactam antibiotic, occupies a specialized hospital market for serious infections caused by multidrug-resistant Gram-negative bacteria. Its commercial opportunity is supported by antimicrobial resistance, hospital stewardship programs, and demand for carbapenem-sparing or carbapenem-restoring therapies. Its financial trajectory remains constrained by restricted use, competition from newer beta-lactam/beta-lactamase inhibitor products, hospital budget pressure, and Merck’s decision not to disclose RECARBRIO sales separately.

The product is strategically important but is not a major Merck revenue contributor. Merck reports RECARBRIO within broader pharmaceutical or hospital-product categories rather than as a standalone revenue line. Public filings therefore do not provide a verified annual RECARBRIO revenue figure.

What is RECARBRIO and which infections does it treat?

RECARBRIO combines three active components:

Component	Role
Imipenem	Carbapenem antibacterial
Cilastatin	Renal dehydropeptidase-I inhibitor that prevents imipenem degradation
Relebactam	Beta-lactamase inhibitor that restores imipenem activity against selected resistant organisms

The FDA initially approved RECARBRIO in 2019 for adults with complicated urinary tract infections and complicated intra-abdominal infections caused by susceptible Gram-negative bacteria. The label was expanded in 2020 to include hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in adults.

The product is administered intravenously, generally every six hours, with renal-dose adjustment. Its clinical value is concentrated in hospital settings where rapid treatment of resistant infections is required and intravenous administration is practical.

RECARBRIO does not cover all carbapenem-resistant pathogens. Relebactam inhibits certain class A and class C beta-lactamases, including KPC and AmpC enzymes, but it does not reliably address metallo-beta-lactamases such as NDM, VIM, and IMP. That limitation affects formulary positioning and competitive demand.

How large is the RECARBRIO market?

RECARBRIO competes in a narrow but expanding market for targeted treatment of multidrug-resistant Gram-negative infections. The addressable market is defined less by the total number of bacterial infections than by the subset involving resistant organisms, critically ill patients, and pathogens susceptible to imipenem-relebactam.

The principal demand drivers are:

• Rising incidence of carbapenem-resistant Enterobacterales and difficult-to-treat Pseudomonas aeruginosa.
• Hospital-acquired and ventilator-associated pneumonia.
• Increased use of rapid molecular diagnostics and antimicrobial susceptibility testing.
• Infectious-disease specialist recommendations for newer agents.
• Hospital preparedness for antimicrobial resistance.
• Government and institutional programs supporting antibiotic development.

The main market constraints are:

• Stewardship restrictions that reserve RECARBRIO for resistant infections.
• Low treatment volumes relative to chronic medicines.
• Short treatment courses.
• Hospital pharmacy budget controls.
• Competing products with broader or more familiar resistance profiles.
• Limited use against metallo-beta-lactamase-producing organisms.

RECARBRIO is therefore a high-value, low-volume hospital product. Its commercial model depends on price per treated course and formulary access, not on broad outpatient penetration.

Who competes with RECARBRIO?

RECARBRIO competes with branded beta-lactam/beta-lactamase inhibitor products and established generic antibiotics. The closest branded competitors include:

Product	Company	Components	Main competitive position
VABOMERE	Melinta Therapeutics	Meropenem/vaborbactam	Strong position against KPC-producing Enterobacterales
ZERBAXA	Merck	Ceftolozane/tazobactam	Important option for resistant Pseudomonas and selected Gram-negative infections
AVYCAZ	AbbVie	Ceftazidime/avibactam	Broad use against several resistant Gram-negative pathogens
FETROJA	Shionogi	Cefiderocol	Option for certain highly resistant Gram-negative organisms, including some metallo-beta-lactamase cases
XERAVA	Tetraphase, now La Jolla/Innoviva-related commercial interests	Eravacycline	Primarily complicated intra-abdominal infections
Generic carbapenems	Multiple manufacturers	Imipenem, meropenem, doripenem	Lower-cost treatment for susceptible organisms

RECARBRIO’s strongest competitive position is against imipenem-nonsusceptible organisms where relebactam restores activity. Its weakness is the absence of meaningful activity against metallo-beta-lactamase producers, where cefiderocol or aztreonam-based strategies may be preferred.

How does RECARBRIO compare with VABOMERE and ZERBAXA?

Category	RECARBRIO	VABOMERE	ZERBAXA
Core beta-lactam	Imipenem	Meropenem	Ceftolozane
Inhibitor	Relebactam	Vaborbactam	Tazobactam
Key target	KPC, AmpC, selected resistant Pseudomonas	Primarily KPC-producing Enterobacterales	Resistant Pseudomonas and selected Enterobacterales
HAP/VAP label	Yes	Yes	Yes
Metallo-beta-lactamase activity	No	No	No
Administration	Intravenous, typically every six hours	Intravenous, typically every eight hours	Intravenous, typically every eight hours
Commercial owner	Merck	Melinta	Merck

Merck’s ownership of both RECARBRIO and ZERBAXA gives it a broad commercial portfolio in hospital Gram-negative infections. The products overlap, but they are not interchangeable. Susceptibility testing, local resistance epidemiology, infection site, renal function, and prior antibiotic exposure determine product selection.

What is the financial trajectory of RECARBRIO?

Merck does not report RECARBRIO revenue as a separate line item in its principal public financial disclosures. The company reports major products individually and groups smaller products into broader categories. As a result, investors cannot calculate verified annual RECARBRIO sales from Merck’s filings alone.

Merck’s overall pharmaceutical revenue reached approximately $60.1 billion in 2023, but the company’s headline performance was driven primarily by Keytruda, Gardasil/Gardasil 9, Januvia/Janumet, and other major products rather than RECARBRIO. RECARBRIO is immaterial to consolidated Merck revenue in percentage terms, even though it has strategic relevance in infectious diseases (Merck & Co., 2024).

What factors could increase RECARBRIO revenue?

Revenue growth would most likely come from:

1. Higher hospital prevalence of infections caused by KPC-producing Enterobacterales and resistant Pseudomonas.
2. Greater recognition of antimicrobial resistance as a hospital-acquired infection risk.
3. Expanded use in empiric therapy for critically ill patients later confirmed to have susceptible organisms.
4. Improved reimbursement for newer antibiotics.
5. Increased adoption in markets with limited access to alternative resistance-directed agents.
6. Clinical evidence supporting outcomes in severe pneumonia and bloodstream infections.

Growth would not necessarily translate into high volume. Antimicrobial stewardship programs may increase the product’s clinical importance while limiting inappropriate utilization.

What factors could reduce RECARBRIO revenue?

The main downside risks are:

• Continued genericization of imipenem and meropenem.
• Use of AVYCAZ, VABOMERE, FETROJA, or ZERBAXA based on local resistance patterns.
• Diagnostic uncertainty that leads clinicians to use broader empiric regimens.
• Hospital switching to lower-cost generic carbapenems when susceptibility permits.
• Limited activity against metallo-beta-lactamases.
• Pricing pressure from group purchasing organizations.
• Reduced antibiotic use following infection-control improvements.

The product’s financial trajectory is more likely to be stable or modestly growing than to resemble the growth profile of a specialty oncology or immunology product.

What FDA regulatory status does RECARBRIO have?

RECARBRIO has FDA approval for adults with:

• Complicated urinary tract infections, including pyelonephritis.
• Complicated intra-abdominal infections, in combination with metronidazole.
• Hospital-acquired bacterial pneumonia.
• Ventilator-associated bacterial pneumonia.

The product received Qualified Infectious Disease Product status under the Generating Antibiotic Incentives Now provisions of the Food and Drug Administration Safety and Innovation Act. QIDP designation can provide an additional five years of exclusivity when applicable to an approved antibacterial product (FDA, 2019; FDA, 2020).

RECARBRIO is not a biologic and does not face biosimilar competition. Any future competition would come from generic versions, alternative branded antibiotics, or new antibacterial agents.

What patents protect RECARBRIO?

RECARBRIO is protected by a combination of patent rights covering relebactam, pharmaceutical compositions, dosing, and use against resistant bacterial infections. Patent protection can differ by component and by jurisdiction.

The relevant intellectual-property categories include:

Protection category	Commercial relevance
Relebactam composition patents	Protect the active beta-lactamase inhibitor
Combination patents	Cover imipenem, cilastatin, and relebactam compositions
Formulation patents	Protect injectable formulations and stability characteristics
Method-of-use patents	Cover treatment of selected resistant infections
Manufacturing patents	Protect synthesis, purification, and formulation processes
Regulatory exclusivity	Delays approval or marketing of certain competing products independently of patents

Exact expiration dates must be assessed patent-by-patent because U.S. patent-term adjustment, patent-term extension, terminal disclaimers, pediatric exclusivity, and Orange Book listing status can change the effective loss-of-exclusivity date.

What is the Orange Book status of RECARBRIO?

RECARBRIO is an FDA-approved small-molecule injectable drug and is eligible for Orange Book patent listings. Orange Book-listed patents can create a regulatory barrier for an ANDA applicant that seeks approval before the relevant patents expire.

A generic applicant may file:

• Paragraph I certification if no patent information is listed.
• Paragraph II certification if the patent has expired.
• Paragraph III certification if the applicant accepts approval after patent expiration.
• Paragraph IV certification asserting that the patent is invalid, unenforceable, or not infringed.

The commercial significance of a Paragraph IV challenge depends on the scope of listed claims. A challenge to a narrow method-of-use patent may not block approval for all labeled uses. A challenge to a composition or formulation patent can create a more substantial litigation risk.

When does RECARBRIO lose exclusivity?

RECARBRIO’s effective exclusivity period is determined by the interaction of:

• Patent expiration dates.
• QIDP exclusivity.
• Any applicable new chemical entity or other regulatory exclusivity.
• Patent-term extension.
• Pediatric exclusivity.
• The scope of any Orange Book-listed patents.
• The approval pathway used by a generic applicant.

The product was approved in 2019, and QIDP status could extend qualifying exclusivity by five years beyond the underlying exclusivity period. That regulatory protection does not necessarily prevent all competitive products, because it applies within the statutory framework and does not eliminate patents covering alternative products or non-identical formulations.

For financial planning, the principal risk is a staged loss of protection rather than a single event. A generic competitor may first enter for a narrow indication, challenge a method-of-use patent, or wait for composition and formulation patents to expire.

Which companies could challenge RECARBRIO?

Potential challengers include large injectable-generic manufacturers and specialty hospital-drug companies such as Sandoz, Fresenius Kabi, Hikma, Viatris, Teva, Eugia, Dr. Reddy’s Laboratories, and Amneal. A Paragraph IV filing would depend on the commercial attractiveness of the market, the complexity of relebactam manufacturing, and the remaining patent term.

The market may be less attractive to generic manufacturers than a high-volume outpatient drug because:

• RECARBRIO is administered intravenously.
• Hospital demand is concentrated among a limited number of buyers.
• Manufacturing requires a three-component combination.
• Relebactam synthesis and impurity control may raise technical barriers.
• Stewardship limits annual unit volume.
• Generic price erosion could be substantial after entry.

How strong is the RECARBRIO patent estate?

The estate has meaningful defensive value because it covers a newer beta-lactamase inhibitor used in a fixed injectable combination. Its strength depends on whether core composition claims remain enforceable and whether generic applicants can design around formulation or use claims.

The strongest protection generally comes from claims directed to:

• Relebactam itself.
• Specific pharmaceutical combinations.
• Stable injectable compositions.
• Defined dosing regimens.
• Treatment of infections caused by particular resistant organisms.

Method-of-use claims are more vulnerable than composition claims because they may be narrowed by labeling, clinical evidence, or claim-construction disputes. Manufacturing patents can delay or complicate entry but may not prevent a non-infringing alternative process.

What generic entry risks exist for RECARBRIO?

Generic entry would likely produce rapid price erosion in hospital procurement, but the volume impact may be gradual because formulary adoption requires clinical confidence, susceptibility data, and reliable supply.

A likely entry sequence is:

Stage	Market effect
Patent challenge or tentative ANDA approval	Limited immediate effect
First commercial generic	Contracting pressure and price concessions
Multiple generic entrants	Significant price erosion
Broad hospital conversion	Lower Merck volume and lower net price
Mature generic market	Product retained for clinical niches and supply security

The absence of biosimilar risk reduces one category of competition, but it does not offset the eventual threat from generic versions and branded alternatives.

What licensing deals affect RECARBRIO?

RECARBRIO is a Merck product associated with the company’s post-acquisition infectious-disease portfolio, including assets obtained through Merck’s acquisition of Cubist Pharmaceuticals. Merck completed the Cubist acquisition in 2015, strengthening its hospital anti-infective business and adding products and development programs in resistant bacterial infections (Merck & Co., 2015).

The commercial implications are significant because Merck controls both RECARBRIO and ZERBAXA. That portfolio structure permits coordinated hospital contracting, clinical education, and resistance-focused positioning. No separately disclosed third-party licensing arrangement is required to explain RECARBRIO’s current commercial ownership.

What litigation affects RECARBRIO?

No major publicly established RECARBRIO patent-litigation event can be identified from the core regulatory and corporate record through the available reporting period. The principal future litigation risk would arise from an ANDA Paragraph IV filing involving relebactam composition, combination, formulation, or method-of-use patents.

A Paragraph IV notice could trigger a 45-day period for Merck to file suit. A timely patent action may create a 30-month stay of FDA approval under the Hatch-Waxman framework, subject to statutory exceptions and court rulings.

What is the geographic coverage of RECARBRIO?

RECARBRIO has been commercialized in the United States and selected international markets under Merck’s hospital anti-infective portfolio. Geographic demand is highest in markets with:

• High rates of antimicrobial resistance.
• Advanced hospital microbiology.
• Reimbursement for reserve antibiotics.
• Infectious-disease specialist coverage.
• Broad access to intensive-care services.

Emerging markets may have substantial resistance burdens but lower commercial uptake because of price, diagnostic limitations, and restricted hospital budgets. U.S. revenue is likely to remain strategically important because the United States supports higher branded-antibiotic pricing and has a sophisticated market for resistant-infection therapies.

What manufacturing and intellectual-property barriers protect RECARBRIO?

RECARBRIO requires production of a sterile injectable fixed combination with consistent potency, impurity control, compatibility, and stability. The technical burden is higher than for a conventional single-active oral generic.

Potential manufacturing barriers include:

• Sourcing or synthesizing relebactam at commercial scale.
• Maintaining stability across the combined formulation.
• Sterile manufacturing capacity.
• Validating renal-dose presentations and packaging.
• Meeting injectable-product quality requirements.
• Demonstrating pharmaceutical equivalence for an ANDA.

These barriers can delay generic entry, but they are not permanent. Large injectable manufacturers with established hospital portfolios may be able to overcome them.

Key Takeaways

• RECARBRIO is a targeted hospital antibiotic for serious Gram-negative infections, not a broad-volume product.
• Its value comes from restoring imipenem activity against selected resistant organisms.
• Merck does not disclose standalone RECARBRIO revenue, preventing a verified product-level financial model from public filings.
• The product competes with VABOMERE, ZERBAXA, AVYCAZ, FETROJA, and low-cost generic carbapenems.
• QIDP status and patents extend protection, but the exact loss-of-exclusivity date depends on patent-level analysis.
• RECARBRIO has no biosimilar risk because it is a small-molecule antibiotic.
• Generic entry would likely create rapid price pressure, although hospital adoption could be gradual.
• The largest clinical limitation is weak activity against metallo-beta-lactamase-producing organisms.
• Merck’s ownership of RECARBRIO and ZERBAXA supports portfolio-based hospital contracting.
• Long-term revenue is more likely to be stable or modestly growing than material to Merck’s consolidated financial results.

FAQs About RECARBRIO Market and Exclusivity

Is RECARBRIO a blockbuster drug?

No. Merck does not report RECARBRIO as a standalone blockbuster product, and its hospital-only, stewardship-controlled use limits total treatment volume.

Does RECARBRIO have biosimilar competition?

No. RECARBRIO is a small-molecule injectable antibiotic. Potential competitors would be generic versions or alternative antibacterial products, not biosimilars.

Is RECARBRIO effective against CRE infections?

It can be effective against selected carbapenem-resistant Enterobacterales, particularly infections involving KPC-producing organisms that remain susceptible to imipenem-relebactam. Susceptibility testing is required.

Is RECARBRIO stronger than VABOMERE?

Neither product is universally superior. RECARBRIO may be preferred for susceptible imipenem-resistant organisms and some resistant Pseudomonas cases, while VABOMERE has a strong position against KPC-producing Enterobacterales.

What is the largest commercial risk to RECARBRIO?

The largest risk is competition from other resistance-directed antibiotics combined with eventual generic entry, particularly because stewardship limits volume and many resistant pathogens fall outside relebactam’s activity spectrum.

References

1. Food and Drug Administration. (2019). FDA approves new treatment for complicated urinary tract and intra-abdominal infections. U.S. Department of Health and Human Services.

2. Food and Drug Administration. (2020). FDA approves antibiotic for hospital-acquired and ventilator-associated bacterial pneumonia. U.S. Department of Health and Human Services.

3. Merck & Co., Inc. (2015). Merck completes acquisition of Cubist Pharmaceuticals. Merck investor and corporate communications.

4. Merck & Co., Inc. (2024). 2023 annual report. Merck & Co., Inc.

5. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.

6. U.S. Congress. (2012). Food and Drug Administration Safety and Innovation Act, Pub. L. No. 112-144, Title VIII.