RECARBRIO Drug Patent Profile

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.

This drug has seventy-three patent family members in thirty-eight countries.

The generic ingredient in RECARBRIO is cilastatin sodium; imipenem; relebactam. There are sixteen drug master file entries 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 March 21, 2033. 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

International Patents:	73
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

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
Connecticut Children's Medical Center	Phase 4
Hartford Hospital	Phase 4
St. Christopher's Hospital for Children	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 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
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		RX	Yes	Yes			Y	Y
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		RX	Yes	Yes
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		RX	Yes	Yes

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

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
Portugal	2231667
Japan	5038509
Japan	5422020
Japan	2012214475
Japan	5597164
Honduras	2010001395
South Korea	20100130176

Supplementary Protection Certificates for RECARBRIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2231667	2020023	Norway		PRODUCT NAME: RELEBACTAM ELLER ET MONOHYDRAT DERAV; REG. NO/DATE: EU/1/19/1420 20200220
2231667	20C1030	France		PRODUCT NAME: RELEBACTAM OU UN MONOHYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/19/1420 20200217
2666774	SPC/GB20/030	United Kingdom		PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, AND IMIPENEM.; REGISTERED: UK EU/1/19/1420 (NI) 20200217; UK PLGB 53095/0053 20200217
2666774	CA 2020 00037	Denmark		PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217
2231667	787	Finland
2666774	122020000035	Germany		PRODUCT NAME: RELEBACTAM, ODER RELEBACTAM IN FORM DES MONOHYDRATES, UND IMIPENEM; REGISTRATION NO/DATE: EU/1/19/1420 20200213
2666774	PA2020517	Lithuania		PRODUCT NAME: RELEBAKTAMAS, PASIRINKTINAI MONOHIDRATO PAVIDALU, IR IMIPENEMAS; REGISTRATION NO/DATE: EU/1/19/1420 20200213

Market Dynamics and Financial Trajectory for RECARBRIO

Last updated: July 27, 2025

Introduction

RECARBRIO (imipenem-cilastatin-relebactam) is a broad-spectrum antibiotic approved by the U.S. Food and Drug Administration (FDA) in August 2019. Manufactured by Merck & Co., it addresses multidrug-resistant bacterial infections, notably complicated urinary tract infections (cUTIs), complicated intra-abdominal infections (cIAIs), and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP). As antimicrobial resistance (AMR) escalates globally, RECARBRIO’s market landscape and financial outlook demand close examination to inform strategic decision-making for stakeholders.

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Market Landscape and Competitive Positioning

Global Antimicrobial Resistance Trends

The rising prevalence of AMR constitutes a pivotal market driver for RECARBRIO. According to the CDC, at least 2.8 million antimicrobial-resistant infections occur annually in the U.S., resulting in over 35,000 deaths.[1] Globally, AMR poses an escalating threat, with WHO declaring antibiotic resistance as one of the top ten threats to global health.[2] The shortage of novel antibiotics in pipeline further accentuates the importance of drugs like RECARBRIO.

Epidemiology and Clinical Need

RECARBRIO combats multidrug-resistant pathogens like Pseudomonas aeruginosa and Enterobacterales, especially carbapenem-resistant strains (CRE). CRE infections exhibit high morbidity, mortality, and limited treatment options, reinforcing the urgent need for effective therapeutics. The rising incidence of these infections in hospital settings supports ongoing demand.

Competitive Landscape

RECARBRIO faces competition predominantly from other β-lactam/β-lactamase inhibitor combinations, including:

• Zerbaxa (cefepime-tazobactam) by Pfizer
• Vabomere (meropenem-vaborbactam) by Melinta Therapeutics
• Zavicefta by Astellas Pharma (approved in Europe, pending FDA approval)

However, RECARBRIO’s unique blend targeting multidrug-resistant Gram-negative bacteria positions it favorably amid expanding resistance profiles.

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Market Dynamics Influencing RECARBRIO’s Adoption

Regulatory Environment

The regulatory landscape is pivotal. The FDA’s approval pathway designated RECARBRIO a Qualified Infectious Disease Product (QIDP), accelerating review processes and affording incentives such as priority review vouchers. Its designation as a New Chemical Entity (NCE) enhances market exclusivity, projecting favorable revenue potential.

Hospital and Healthcare Settings

The emphasis on hospital-acquired infections elevates RECARBRIO's market share within inpatient settings. Hospitals and ID specialists play a primary role in antibiotic stewardship protocols, influencing prescribing patterns. Increasing adoption hinges on demonstrating clinical efficacy, safety, and cost-effectiveness.

Pricing and Reimbursement

Pricing strategies significantly impact market penetration. RECARBRIO commands premium pricing aligned with other specialty antibiotics, justified by its novel mechanism and critical role in resistant infections.[3] Reimbursement pathways through CMS and private insurers influence access, especially given stewardship initiatives to curb antibiotic overuse.

Global Market Penetration

While initial focus centers on the U.S., expansion into Europe, Asia-Pacific, and emerging markets expands revenue streams. Countries with rising antimicrobial resistance and constrained antibiotic pipelines represent high-growth opportunities, contingent upon regulatory approvals.

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Financial Trajectory Analysis

Revenue Projections and Growth Drivers

Merck’s financial disclosures forecast that RECARBRIO will contribute progressively to its antimicrobial portfolio's revenue. The initial sales focus targets high-resource inpatient settings, with an optimistic outlook aligned with AMR trends.

• Year 1 (2020): Launch and initial adoption constrained by limited awareness and hospital formulary approvals.[4]
• Years 2-3 (2021–2023): Growing adoption driven by clinical guidelines and expanding evidence base.
• Beyond Year 3: Market saturation and generics’ impact are unlikely given patent exclusivity, but competitive dynamics and resistance development could cap growth.

Market Penetration and Pricing Strategies

Advanced hospital contracting, bundled purchasing, and formulary listings are vital for broader adoption. Reimbursement policies favor antibiotics with demonstrated cost-effectiveness, potentially facilitating premium pricing justification.

Research and Development (R&D) Impact

Continuous investment in clinical trials and real-world evidence supports the drug’s positioning, potentially leading to expanded indications—a significant contributor to long-term revenue growth.

Challenges and Risks

Potential hurdles include:

• Resistance Development: Emergence of resistance against RECARBRIO could diminish its efficacy, impacting sales.
• Regulatory Delays or Denials: Failure to expand indications or obtain approvals in key markets hampers growth.
• Pricing Pressures: Increasing pressure to reduce drug prices and contain healthcare costs could constrain revenue growth.

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Forecasting and Strategic Outlook

The financial trajectory for RECARBRIO appears cautiously optimistic:

• Short-Term (1–3 years): Revenue accumulation driven by increased hospital adoption, expanding indications, and strategic marketing.
• Medium-to-Long Term: Stabilization occurs as market share consolidates, with growth potentially plateauing amid emerging competition.

Given the rising tide of AMR and the dearth of new antibiotics, RECARBRIO’s market position is bolstered. However, its ultimate financial success hinges on effective stewardship, ongoing R&D, and global market expansion.

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Conclusion

The market dynamics for RECARBRIO are shaped by global antimicrobial resistance trends, clinical needs, and strategic positioning within a competitive landscape. Financial prospects are favorable, supported by increasing adoption in hospital settings and regulatory incentives, but face inherent risks from resistance development and pricing pressures. Stakeholders must navigate these factors carefully to maximize the drug’s market potential and financial trajectory.

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Key Takeaways

• The global rise in multidrug-resistant infections sustains demand for RECARBRIO, especially in hospital settings.
• Regulatory advantages and active clinical development enhance its market positioning.
• Pricing strategies and reimbursement policies directly influence adoption and revenue.
• Potential resistance development remains a long-term threat to sales sustainability.
• Expanding into international markets offers significant growth potential amid global AMR concerns.

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FAQs

1. How does RECARBRIO differentiate itself from other antibiotics in the market?
RECARBRIO combines imipenem with cilastatin and relebactam, targeting resistant Gram-negative bacteria, including carbapenem-resistant strains, offering efficacy against pathogens resistant to other antibiotics.

2. What are the main factors driving RECARBRIO’s revenue growth?
Increased use in hospital-acquired infections, expanding indications, favorable regulatory status, and the rising global burden of resistant infections drive growth.

3. What challenges could impact RECARBRIO’s market penetration?
Emergence of bacterial resistance, competition from similar agents, pricing pressures, and delays in regulatory approval in key markets could impede growth.

4. How does antimicrobial stewardship influence RECARBRIO’s adoption?
Stewardship programs promote judicious antibiotic use, potentially restricting unnecessary prescriptions but also encouraging appropriate use of targeted agents like RECARBRIO, thus affecting market demand.

5. What is the outlook for RECARBRIO’s global market expansion?
With rising antimicrobial resistance globally, especially in Asia and Europe, RECARBRIO has substantial growth opportunities, contingent on regulatory approvals and localized pricing strategies.

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Sources
[1] CDC. Antibiotic Resistance Threats in the United States, 2019.
[2] WHO. Antimicrobial Resistance. Fact Sheet, 2021.
[3] Merck. RECARBRIO product monograph, 2019.
[4] Market analyses from IQVIA and EvaluatePharma, 2022.