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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-one 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.

Indicators of Generic Entry

Summary for RECARBRIO

International Patents:	71
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	5
Drug Prices:	Drug price information 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
Merck Sharp & Dohme LLC	Phase 4
Connecticut Children's Medical Center	Phase 4
Hartford Hospital	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
Slovenia	2666774
Japan	2011510012
Serbia	53052	INHIBITORI BETA-LAKTAMAZE (BETA-LACTAMASE INHIBITORS)
European Patent Office	2231667	INHIBITEURS DE BÊTA-LACTAMASE (BETA-LACTAMASE INHIBITORS)
Denmark	2231667

Supplementary Protection Certificates for RECARBRIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2666774	LUC00166	Luxembourg		PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, ET IMIPENEME; AUTHORISATION NUMBER AND 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
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	132020000000070	Italy		PRODUCT NAME: RELEBACTAM, OPZIONALMENTE IN FORMA DEL MONOIDRATO, E IMIPENEM(RECARBRIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1420, 20200217
2231667	LUC00165	Luxembourg		PRODUCT NAME: RELEBACTAM, OU SON MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217

RECARBRIO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RECARBRIO

Introduction to RECARBRIO

RECARBRIO, a combination antibacterial drug consisting of imipenem, cilastatin, and relebactam, has been a significant addition to the arsenal against Gram-negative bacterial infections. Approved by the FDA for the treatment of complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), and more recently for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), RECARBRIO has carved out a niche in the antibiotics market.

Market Size and Growth

The global antibiotics market, within which RECARBRIO operates, is projected to reach USD 68.03 billion by 2030, growing at a CAGR of 4.2% from 2024 to 2030[1].

Key Market Segments

Drug Class

The penicillin drug class, which includes carbapenems like imipenem, led the market in 2023. However, the cephalosporin segment is anticipated to register the fastest CAGR from 2024 to 2030, indicating a shift in market dynamics that could impact RECARBRIO's growth[1].

Action Mechanism

RECARBRIO's mechanism of action, involving a carbapenem antibacterial (imipenem), a renal dehydropeptidase inhibitor (cilastatin), and a beta-lactamase inhibitor (relebactam), positions it well in the market. The RNA synthesis inhibitors segment, which is projected to register the fastest CAGR, suggests that innovative mechanisms like those in RECARBRIO will be in high demand[1].

Type

The generic type segment holds the largest market share due to affordability and government initiatives promoting generic drugs. However, branded drugs like RECARBRIO, with their unique formulations and FDA approvals, continue to attract significant market share due to their efficacy and the lack of alternative treatments for certain infections[1].

Regional Market Dynamics

Asia-Pacific

This region is expected to exhibit the fastest CAGR over the forecast period due to rising investments by leading players and the high adoption of generic antibiotics. However, the approval and adoption of innovative drugs like RECARBRIO in this region could also drive growth, especially given the increasing healthcare spending and demand for advanced treatments[1].

Regulatory and Government Support

Governmental measures such as the Generating Antibiotics Incentives Now Act, the Global Research on Antimicrobial Resistance (GRAM) Project, and the Global Antibiotic Research & Development Partnership (GARDP) are crucial for the development and approval of new antibiotics. RECARBRIO's FDA approvals, including the Qualified Infectious Disease Product (QIDP) designation, highlight the regulatory support for such innovative drugs[1][3].

Clinical Efficacy and Market Impact

Clinical Trials

The approval of RECARBRIO for HABP/VABP was based on the RESTORE-IMI 2 trial, which demonstrated non-inferiority to piperacillin/tazobactam in 28-day all-cause mortality and clinical response. Such clinical efficacy data are critical for market acceptance and adoption by healthcare providers[4].

Expert Opinions

"RECARBRIO provides an important addition to our toolkit in the ongoing fight against infections caused by certain Gram-negative pathogens," said Dr. Keith Kaye, emphasizing the drug's value in treating difficult-to-treat infections[3].

Financial Trajectory

Revenue Potential

Given the growing demand for effective antibiotics and the specific indications for which RECARBRIO is approved, the drug is expected to contribute significantly to Merck's revenue. The global antibiotics market growth and the increasing prevalence of antibiotic-resistant infections will drive the financial performance of RECARBRIO.

Competitive Landscape

RECARBRIO competes in a market with other antibacterial drugs, but its unique combination and FDA approvals for multiple indications give it a competitive edge. The drug's ability to treat infections with limited or no alternative treatment options positions it as a valuable asset in Merck's portfolio[3][4].

Dosage and Administration

The dosing and administration of RECARBRIO, including adjustments for renal impairment, are critical factors influencing its market adoption. The drug's administration via intravenous infusion and the need for dosage adjustments in patients with renal impairment ensure that it is used effectively and safely, which can impact its financial performance by reducing adverse reactions and improving patient outcomes[2][5].

Risks and Challenges

Development of Drug-Resistant Bacteria

One of the significant challenges is the risk of developing drug-resistant bacteria. Prescribing RECARBRIO only for proven or strongly suspected bacterial infections is crucial to maintain its effectiveness and reduce this risk[3].

Adverse Reactions

The drug is associated with serious adverse reactions such as hypersensitivity reactions and seizures, which need to be carefully managed to ensure patient safety and maintain market confidence[2].

Key Takeaways

• Market Growth: The global antibiotics market is expected to grow at a CAGR of 4.2% from 2024 to 2030.
• Regulatory Support: FDA approvals and governmental initiatives support the development and adoption of RECARBRIO.
• Clinical Efficacy: RECARBRIO has demonstrated non-inferiority in clinical trials, making it a valuable treatment option.
• Regional Dynamics: Asia-Pacific is expected to exhibit the fastest CAGR, driven by rising investments and high adoption of antibiotics.
• Financial Potential: RECARBRIO is expected to contribute significantly to Merck's revenue due to its unique formulation and FDA approvals.

FAQs

Q1: What are the primary indications for RECARBRIO? RECARBRIO is indicated for the treatment of complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP)[3][4].

Q2: How does RECARBRIO work? RECARBRIO is a combination of imipenem (a carbapenem antibacterial), cilastatin (a renal dehydropeptidase inhibitor), and relebactam (a beta-lactamase inhibitor), which together provide broad-spectrum activity against Gram-negative bacteria[3][4].

Q3: What are the dosage adjustments for patients with renal impairment? Patients with renal impairment require dosage reductions of RECARBRIO, with specific adjustments based on creatinine clearance (CLcr) levels[2][5].

Q4: What are the potential risks associated with RECARBRIO? RECARBRIO is associated with risks such as hypersensitivity reactions, seizures, and the development of drug-resistant bacteria if not used appropriately[2][3].

Q5: How does RECARBRIO compare to other antibacterial drugs in clinical trials? RECARBRIO has demonstrated non-inferiority to piperacillin/tazobactam in clinical trials for HABP/VABP, highlighting its efficacy in treating serious infections[4].

Sources

1. Global Antibiotics Market Analysis Report 2024-2030 - Globenewswire
2. Prescribing Information - RECARBRIO - Merck.com
3. FDA Approves Merck's RECARBRIO for cUTI and cIAI - Merck.com
4. FDA Approves Merck's RECARBRIO for HABP/VABP - Merck.com
5. Dosing and Administration for RECARBRIO - MerckConnect.com