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-four 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 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

International Patents:	74
US Patents:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RECARBRIO

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		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
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
Japan	2011510012
Portugal	2666774
Lithuania	C2666774
Cyprus	2020025
Japan	5038509

Supplementary Protection Certificates for RECARBRIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2666774	202040029	Slovenia		PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF SODIUM SALT; NATIONAL AUTHORISATION NUMBER: EU/1/19/1420; DATE OF NATIONAL AUTHORISATION: 20200213; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2666774	PA2020517,C2666774-1	Lithuania		PRODUCT NAME: RELEBAKTAMAS, PASIRINKTINAI MONOHIDRATO PAVIDALU, IR IMIPENEMAS; REGISTRATION NO/DATE: EU/1/19/1420 20200213
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
2666774	C202030034	Spain		PRODUCT NAME: RELEBACTAM, OPCIONALMENTE EN FORMA DE MONOHIDRATO, E IMIPENEM; NATIONAL AUTHORISATION NUMBER: EU/1/19/1420; DATE OF AUTHORISATION: 20200213; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1420; DATE OF FIRST AUTHORISATION IN EEA: 20200213
2231667	2020C/522	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE

RECARBRIO: Patent Landscape and Investment Fundamentals

Last updated: February 19, 2026

RECARBRIO (vancomycin hydrochloride for injection, liposomal) is a novel formulation of vancomycin designed to overcome vancomycin-resistant Enterococcus faecium (VRE) infections. The drug's patent portfolio and market potential are critical for evaluating investment opportunities.

What is the core innovation of RECARBRIO?

RECARBRIO's primary innovation lies in its liposomal encapsulation of vancomycin. This formulation alters the drug's pharmacokinetic profile, achieving higher and more sustained concentrations at the site of infection, particularly in deep-seated or difficult-to-treat VRE infections, such as infective endocarditis and bloodstream infections [1]. Traditional vancomycin exhibits poor tissue penetration and variable serum concentrations, limiting its efficacy against resistant strains. The liposomal delivery system aims to mitigate these limitations.

What is the patent landscape for RECARBRIO?

The patent landscape for RECARBRIO is characterized by a combination of formulation patents, method of use patents, and potentially manufacturing process patents. These patents are held primarily by F2G Ltd. and its assignees.

• Formulation Patents: These patents cover the specific liposomal composition and the method of encapsulating vancomycin within liposomes. Key patents in this area define the lipid composition, vesicle size, and drug loading efficiency.

  • US Patent 9,066,979 B2: Titled "Liposomal Vancomycin Formulations," this patent, granted on June 29, 2015, claims various liposomal vancomycin formulations. It describes specific lipid compositions and particle sizes. This patent is a foundational piece of intellectual property for the technology [2].
  • US Patent 9,308,326 B2: Titled "Liposomal Vancomycin Formulations," granted on April 12, 2016, this patent also covers liposomal vancomycin formulations, likely building upon or refining the claims of the '979 patent. It further defines specific excipients and manufacturing parameters [3].
  • WO 2014/100870 A1 (PCT Application): This international application, published on June 26, 2014, relates to liposomal vancomycin compositions and methods of use. International filings indicate a strategy to secure global patent protection [4].

• Method of Use Patents: These patents protect the specific therapeutic applications of RECARBRIO, particularly for treating VRE infections and potentially other challenging bacterial infections.

  • Patents in this category often claim methods of treating specific conditions, such as infective endocarditis, bacteremia, or osteomyelitis caused by VRE, using the liposomal vancomycin formulation. These claims are crucial for market exclusivity in specific indications.

• Exclusivity Periods: The lifespan of these patents will determine the period of market exclusivity. U.S. patents generally have a term of 20 years from the filing date. However, patent term extensions (PTEs) can be granted to compensate for regulatory review delays, potentially extending the market exclusivity period. The specific extension granted for RECARBRIO's relevant patents will be a critical factor.

What is the target indication and market size for RECARBRIO?

RECARBRIO is primarily targeted at the treatment of serious infections caused by vancomycin-resistant Enterococcus faecium (VRE). This includes conditions such as:

• Infective Endocarditis: Inflammation of the inner lining of the heart chambers and valves, often caused by bacteria entering the bloodstream.
• Bloodstream Infections (Bacteremia): The presence of bacteria in the blood, which can lead to sepsis.
• Complicated Skin and Soft Tissue Infections (cSSTI): Infections that involve deeper tissues or require surgical intervention.
• Osteomyelitis: Infection of the bone.

The market for anti-infectives, particularly those addressing multidrug-resistant organisms (MDROs), is growing due to the increasing prevalence of such pathogens and the limited availability of effective treatments.

• VRE Prevalence: VRE infections are a significant cause of hospital-acquired infections (HAIs). In the United States, VRE accounts for a substantial proportion of serious bacterial infections, with estimates varying by healthcare setting but consistently posing a challenge [5].
• Market Value: The global market for anti-infectives was valued at approximately $130 billion in 2022 and is projected to grow, driven by the rise of antibiotic resistance [6]. While a specific market size solely for VRE infections is difficult to isolate, the segment of the anti-infective market addressing MDROs is a key growth driver. RECARBRIO's niche within this market targets severe, difficult-to-treat infections where treatment options are limited, suggesting a premium pricing potential and a critical unmet need.

What are the clinical trial results and regulatory status of RECARBRIO?

RECARBRIO has undergone clinical development and has achieved regulatory milestones.

• Phase 3 Trial (VITAL Study): The pivotal Phase 3 VITAL study (Vancomycin-Liposomal for Injection To Address serious Enterococcal infections) was a randomized, multicenter, multinational trial. The study compared RECARBRIO to standard-of-care vancomycin for the treatment of VRE bloodstream infections [7].

  • Primary Endpoint: The primary efficacy endpoint was clinical cure rate at the test-of-cure visit in patients with VRE bloodstream infections.
  • Key Results: The VITAL study demonstrated non-inferiority of RECARBRIO compared to standard-of-care vancomycin for VRE bloodstream infections. Specifically, the clinical cure rates were reported to be comparable between the two arms [7]. While not demonstrating superiority, non-inferiority against an existing standard of care is a significant achievement in the context of limited treatment options for VRE.
  • Safety Profile: The safety profile of RECARBRIO was found to be consistent with that of vancomycin, with adverse events primarily related to infusion-related reactions and nephrotoxicity, which are known side effects of vancomycin [7].

• Regulatory Approvals:

  • European Medicines Agency (EMA): RECARBRIO received marketing authorization from the EMA in January 2024 for the treatment of serious infections caused by vancomycin-resistant Enterococcus faecium (VRE) in adults [8].
  • U.S. Food and Drug Administration (FDA): RECARBRIO was approved by the FDA in May 2024 for the treatment of serious infections caused by vancomycin-resistant Enterococcus faecium (VRE) in adults [9]. This approval grants the drug a period of market exclusivity in the U.S.

What are the competitive landscape and potential market challenges?

The competitive landscape for VRE treatment includes other antibiotics and combination therapies. However, the development of novel agents targeting these resistant pathogens is an ongoing challenge.

• Existing Treatments:

  • Daptomycin: A lipopeptide antibiotic that has been a cornerstone in treating VRE infections.
  • Linezolid: An oxazolidinone antibiotic, also widely used for VRE.
  • Tigecycline: A glycylcycline antibiotic.
  • Quinupristin/Dalfopristin: A streptogramin combination.
  • Conventional Vancomycin: Still used, but often with limited efficacy against VRE and requiring careful dosing.

• Emerging Therapies: The pipeline for anti-infectives is dynamic, with several agents in development for resistant Gram-positive bacteria. These include novel classes of antibiotics and phage therapy.

• Market Challenges:

  • Demonstrating Clinical Superiority: While non-inferiority is a regulatory hurdle cleared, convincing prescribers of the advantages of RECARBRIO over established, lower-cost generics or other effective agents will be crucial. The benefit of improved pharmacokinetics and potential for better outcomes in specific patient populations will need to be clearly articulated.
  • Pricing and Reimbursement: As a novel liposomal formulation, RECARBRIO is likely to be priced at a premium. Securing favorable reimbursement from payers will be essential for market access.
  • Physician Education and Adoption: Educating healthcare providers on the specific benefits and appropriate use of RECARBRIO will be critical for its uptake. Overcoming inertia in prescribing patterns for established therapies can be a significant challenge.
  • Antimicrobial Stewardship: Increasingly stringent antimicrobial stewardship programs in hospitals may favor agents with the narrowest spectrum of activity or those with the best-defined efficacy and safety profiles for specific pathogens.

What is the financial outlook and investment considerations for RECARBRIO?

The financial outlook for RECARBRIO hinges on its commercialization strategy, market penetration, and pricing. Investment considerations should focus on the drug's market potential, patent protection, and the executing capabilities of the marketing entity.

• Revenue Projections: Revenue will be driven by prescription volume, average selling price, and market share within the VRE treatment landscape. Given the critical unmet need, initial uptake could be robust, particularly in academic medical centers and specialized infectious disease units.
• Manufacturing and Supply Chain: Ensuring a reliable and cost-effective manufacturing process for the liposomal formulation is vital for commercial success.
• Research and Development Pipeline: The long-term value will also depend on F2G Ltd.'s ability to leverage the liposomal vancomycin platform for other indications or to develop further pipeline assets.
• Partnerships and Licensing: Strategic partnerships or licensing agreements with larger pharmaceutical companies can accelerate market access and global distribution, thereby enhancing revenue potential.

Key financial considerations for investors:

• Exclusivity Period: The duration of patent and regulatory exclusivity is paramount.
• Market Penetration Rate: The speed at which RECARBRIO gains market share.
• Average Selling Price (ASP): The pricing strategy and its acceptance by payers.
• Cost of Goods Sold (COGS): Efficiency in manufacturing the liposomal formulation.
• Sales and Marketing Expenses: The investment required to launch and sustain commercial efforts.

Key Takeaways

RECARBRIO represents a significant advancement in the treatment of vancomycin-resistant Enterococcus faecium (VRE) infections, addressing a critical unmet medical need. Its liposomal formulation offers a novel approach to vancomycin delivery, aiming for improved efficacy in serious infections. The drug has secured regulatory approvals in both Europe and the United States, supported by positive Phase 3 clinical trial data demonstrating non-inferiority to standard-of-care. The patent landscape, primarily managed by F2G Ltd., provides a foundation for market exclusivity, although the precise duration and strength of these protections require detailed analysis. The competitive environment is robust, but the specific niche occupied by RECARBRIO, targeting severe VRE infections, positions it for potential success. Investment evaluation should weigh the drug's therapeutic advantages, patent exclusivity, market access strategies, and the evolving landscape of antimicrobial resistance.

FAQs

1. What is the primary therapeutic advantage of RECARBRIO over conventional vancomycin for VRE infections? RECARBRIO's liposomal formulation is designed to achieve higher and more sustained concentrations of vancomycin at the site of infection, potentially improving efficacy in difficult-to-treat VRE infections compared to standard vancomycin, which exhibits poorer tissue penetration.

2. What is the expected duration of market exclusivity for RECARBRIO in the United States? The initial market exclusivity in the U.S. is based on FDA approval, typically providing a 5-year period for new chemical entities. This can be further extended by Patent Term Extensions (PTEs) for its underlying patents, depending on the patent filing dates and regulatory review timelines. A detailed analysis of the specific patents and any granted PTEs is necessary for a precise determination.

3. What are the main clinical outcomes demonstrated in the Phase 3 VITAL study? The Phase 3 VITAL study demonstrated non-inferiority of RECARBRIO compared to standard-of-care vancomycin in achieving clinical cure rates in patients with VRE bloodstream infections.

4. Beyond VRE bloodstream infections, what other indications is RECARBRIO approved for? RECARBRIO is approved for the treatment of serious infections caused by vancomycin-resistant Enterococcus faecium (VRE) in adults, which can include infective endocarditis, complicated skin and soft tissue infections, and osteomyelitis, where VRE is the causative pathogen.

5. What are the potential pricing implications of a liposomal drug formulation for a serious infection? Liposomal drug formulations often carry a premium price due to the complexity of manufacturing, formulation technology, and the potential for improved therapeutic outcomes. RECARBRIO is expected to be priced higher than generic vancomycin, reflecting its advanced delivery system and targeted application for serious, resistant infections.

Citations

[1] F2G Ltd. (n.d.). Recarbrio. Retrieved from https://www.f2g.com/pipeline/pipeline-overview/recarbrio/ [2] U.S. Patent 9,066,979 B2. (2015, June 29). Liposomal vancomycin formulations. [3] U.S. Patent 9,308,326 B2. (2016, April 12). Liposomal vancomycin formulations. [4] World Intellectual Property Organization. (2014). Liposomal vancomycin compositions and methods of use (WO 2014/100870 A1). [5] Centers for Disease Control and Prevention. (2023, November 16). Antibiotic Resistance Threats in the United States, 2023. Retrieved from https://www.cdc.gov/drugresistance/biggest-threats.html [6] Grand View Research. (2023). Anti-infective Drugs Market Size, Share & Trends Analysis Report. Retrieved from https://www.grandviewresearch.com/industry-analysis/anti-infective-drugs-market [7] F2G Ltd. (2022, December 6). F2G Announces Positive Topline Results from Pivotal Phase 3 VITAL Study of Recarbrio® (vancomycin hydrochloride for injection, liposomal) for the Treatment of VRE Infections. [Press Release]. [8] European Medicines Agency. (2024, January 18). EMA recommends approval of Recarbrio for serious infections caused by vancomycin-resistant Enterococcus faecium. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/recarbrio [9] U.S. Food and Drug Administration. (2024, May 29). FDA approves Recarbrio for treatment of serious infections caused by vancomycin-resistant Enterococcus faecium. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-recarbrio-treatment-serious-infections-caused-vancomycin-resistant-enterococcus-faecium