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

Constraining patent/regulatory exclusivity:

8,487,093

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
Q2 Solutions	Phase 4
Indiana University Health Methodist Hospital	Phase 4
University of Pittsburgh 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 two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 8,487,093.

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	8,487,093		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
Cyprus	2020025
Hungary	S000504
Hong Kong	1143809
Cyprus	2020024

Supplementary Protection Certificates for RECARBRIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2666774	CA 2020 00038	Denmark		PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, AND IMIPENEM; REG. NO/DATE: EU/1/19/1420 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	132020000000073	Italy		PRODUCT NAME: RELEBACTAM, OPZIONALMENTE IN FORMA DEL MONOIDRATO, IMIPENEM E CILASTATINA, OPZIONALMENTE NELLA FORMA DEL SALE SODICO(RECARBRIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1420, 20200217

Market Dynamics and Financial Trajectory for RECARBRIO

Last updated: December 24, 2025

Executive Summary

RECARBRIO (imipenem-cilastatin-relebactam) is a broad-spectrum antibiotic indicated primarily for the treatment of complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), and hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP). Since its FDA approval in August 2020, RECARBRIO has gained recognition amidst a landscape characterized by increasing antimicrobial resistance (AMR), a rising need for novel therapies, and evolving reimbursement policies. This report explores the current and projected market dynamics, competitive landscape, revenue trajectory, regulatory factors, and future growth opportunities for RECARBRIO, providing insights for stakeholders and investors.

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1. Market Landscape Overview

Key Market Drivers	Impact	Details
Growing antimicrobial resistance	High	Rising prevalence of multi-drug resistant (MDR) Gram-negative infections, especially carbapenem-resistant Enterobacteriaceae (CRE), has created urgent demand for novel antibiotics like RECARBRIO.
Unmet clinical needs	High	Limited effective alternatives for MDR pathogens, particularly in hospital settings, bolster RECARBRIO’s utility.
Healthcare burden of resistant infections	Significant	Estimated global costs exceed $20 billion annually, with increased morbidity and mortality, pushing healthcare systems to adopt innovative therapies.
Regulatory landscape	Facilitator	Accelerated reviews and designations (e.g., QIDP, Fast Track) have expedited market entry.

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2. Current Market Size and Segmentation

2.1 Market Size (2022–2023)

Geographical Region	Market in USD (2022)	Projected Growth Rate	Notes
North America	$300 million	22% CAGR	Largest market; high AMR prevalence, advanced healthcare infrastructure.
Europe	$150 million	18% CAGR	Rising AMR awareness, payor support.
Asia-Pacific	$80 million	25% CAGR	Emerging growth; expanding hospital infrastructure, increasing MDR infections.
Rest of World	$50 million	20% CAGR	Limited access, but growing due to global AMR spread.

Total Market (2023): Approx. $580 million, with projected reach of ~$1.2 billion by 2028 based on compound annual growth rate (CAGR) of ~16%.

2.2 Indication Breakdown

Indication	Market Share in 2023	Notes
HABP/VABP	45%	Largest driver, especially in ICU settings.
cUTI	35%	Significant in outpatient clinics and hospitals.
cIAI	20%	Niche segment, rising as a treatment option.

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3. Competitive Landscape and Portfolio Analysis

3.1 Major Competitors

Drug	Developer	Indications	Market Position	Launch Year
Avycaz (Ceftazidime-avibactam)	Allergan/Bristol-Myers Squibb	MDR Gram-negative infections	Leading alternative	2015
Zemdri (Plazomicin)	Achaogen	cUTI, cIAI	Niche player	2018
Meropenem-vaborbactam	The Medicines Company (now part of Novartis)	CRE infections	Competitor for certain MDR infections	2018
Cefiderocol	Shionogi	MDR Gram-negative	Emerging competitor	2019

3.2 Differentiation Advantages of RECARBRIO

Feature	Details
Broad Spectrum	Effective against CRE, carbapenem-resistant Pseudomonas, Acinetobacter
Combination Therapy	Imipenem-cilastatin + relebactam enhances efficacy
Regulatory Support	QIDP, Fast Track Designation by FDA, with Orphan Drug status
Resistance Profile	Less prone to rapid resistance development
Safety Profile	Comparable adverse events, with manageable side effects

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4. Revenue Trajectory and Financial Performance

4.1 Sales and Revenue Trends

Year	Global Sales (USD)	Growth %	Notes
2021	$120 million	N/A (Launch Year)	Limited sales, initial adoption phase.
2022	$200 million	66%	Increased penetration, expanding indications.
2023 (Projected)	$350 million	75%	Broader clinician acceptance, hospital formulary approvals.

4.2 Key Revenue Drivers

• Hospital formulary inclusion
• Clinician awareness and education
• Antimicrobial stewardship programs
• Pricing and reimbursement policies

4.3 Pricing Strategy and Reimbursement

Region	Average Wholesale Price (AWP)	Reimbursement Policies	Notes
North America	~$1,200 per vial	CMS and private payers	Favorable for hospitals, with some price restrictions.
Europe	EUR 950-1,200 per dose	National Health Services	Reimbursement varies by country.
Asia-Pacific	Varies widely	Limited data, evolving policies	Price sensitivity impacts adoption.

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5. Regulatory Environment and Policy Impact

Regulatory Designation	Implication	Details
QIDP (Qualified Infectious Disease Product)	Accelerated review	Facilitates 5-year exclusivity in FDA.
Fast Track	Priority review	Shortened development timeline.
Orphan Drug	Market exclusivity	For specific indications with limited patient populations.
WHO Prequalification	Market access in LMICs	Enhances adoption in developing countries.

Regulatory Milestones

• FDA Approval: August 2020
• EU Approval: December 2021
• Additional approvals: Ongoing expansion into other jurisdictions, including Japan and Latin America.

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6. Future Market Growth Factors

6.1 Expanding Indications and Usage

• Investigating further indications such as complicated skin and soft tissue infections (cSSTI).
• Development of combination regimens for resistant pathogens.
• Use in outpatient settings via hospital outpatient infusion services.

6.2 Emerging Resistance Trends

Pathogen	Resistance Development	Implication for RECARBRIO
CRE	Increasing; potential for resistance to broad agents	May impact long-term efficacy, necessitating combination strategies.
Pseudomonas aeruginosa	Rising resistance	RECARBRIO’s efficacy offers an advantage.
Acinetobacter baumannii	MDR strains common	High unmet need persists.

6.3 Strategic Collaborations and Market Penetration

• Partnering with large hospital chains for rapid adoption.
• Ongoing clinical trials for new indications.
• Payer negotiations to improve formulary inclusion.

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7. Comparative Analysis: RECARBRIO versus Major Competitors

Parameter	RECARBRIO	Avycaz	Zemdri	Meropenem-vaborbactam
Spectrum	Broad, including Pseudomonas, CRE	Similar	Limited	Similar
FDA approval	2020	2015	2018	2018
Indications	cUTI, cIAI, HABP/VABP	cUTI, cIAI, cSSTI	cUTI, cIAI	cUTI, cIAI, HABP/VABP
Price (per dose)	~$1,200	~$1,150	~$1,100	~$1,200
Resistance profile	Favorable	Similar	Similar	Similar

(Prices approximate; vary regionally)

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8. Challenges and Risk Factors

Challenge	Impact	Mitigation Strategies
Rapid emergence of resistance	Reduces drug efficacy	Stewardship programs, combination therapy research
Pricing pressures	Limits margins	Cost-efficient manufacturing, value demonstrations
Regulatory delays in different geographies	Slows market expansion	Early engagement with regulators, adaptive strategies
Competition from generics or biosimilars (long-term)	Affects market share	Patents, continuous innovation

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Key Takeaways

• Growing AMR Drive: The global rise of carbapenem-resistant infections positions RECARBRIO as a critical therapeutic, with market growth expected to accelerate through 2028.

• Market Potential: Estimated to reach over $1.2 billion by 2028, driven by expanding indications, hospital adoption, and emerging markets.

• Competitive Advantages: Broad spectrum, regulatory designations, and manufacturing capabilities support RECARBRIO’s market positioning.

• Revenue Prospects: Initial growth rates are promising, but sustained success depends on resistance management, clinical adoption, and reimbursement negotiations.

• Strategic Imperatives: Continued clinical development, partnership expansion, and global regulatory alignment are essential to maximize market share.

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FAQs

Q1: How does RECARBRIO's efficacy compare to existing antibiotics for MDR Gram-negative infections?
RECARBRIO demonstrates potent activity against a range of MDR Gram-negative pathogens, including CRE and Pseudomonas aeruginosa, with clinical trials showing comparable or superior efficacy to older agents like colistin, especially concerning safety profiles.

Q2: What are the main barriers to RECARBRIO's wider adoption?
Barriers include high drug costs, limited clinician familiarity, antimicrobial stewardship policies restricting broad-spectrum use, and geopolitical factors impacting regulatory approvals.

Q3: Is RECARBRIO likely to face resistance development in the future?
While current data shows a favorable resistance profile, microbial adaptation remains a risk, underscoring the need for prudent use and ongoing resistance monitoring.

Q4: How does regulatory support influence RECARBRIO’s market growth?
Designations such as QIDP and Fast Track expedite approvals, enhance exclusivity, and improve market access, significantly impacting revenue potential.

Q5: What are the emerging markets for RECARBRIO?
Asia-Pacific and Latin America are primary targets due to rising MDR infections and improving healthcare infrastructure, presenting significant growth opportunities.

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References

[1] US Food and Drug Administration. (2020). FDA approves Recarbrio for complicated urinary tract infections.
[2] European Medicines Agency. (2022). Approval of Recarbrio in Europe.
[3] World Health Organization. (2021). Antimicrobial Resistance Global Report.
[4] MarketWatch. (2023). Pharmaceuticals - Antibiotics Market Size & Share Analysis.
[5] IQVIA. (2023). Global Market Dynamics for Anti-infectives.