Cilastatin sodium; imipenem; relebactam - Generic Drug Details

What are the generic drug sources for cilastatin sodium; imipenem; relebactam and what is the scope of freedom to operate?

Cilastatin sodium; imipenem; relebactam is the generic ingredient in one branded drug marketed by Msd Merck Co and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Cilastatin sodium; imipenem; relebactam has seventy-three patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for cilastatin sodium; imipenem; relebactam

International Patents:	73
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cilastatin sodium; imipenem; relebactam
DailyMed Link:	cilastatin sodium; imipenem; relebactam at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cilastatin sodium; imipenem; relebactam

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 cilastatin sodium; imipenem; relebactam

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
Merck Sharp & Dohme Corp.	Phase 3

See all cilastatin sodium; imipenem; relebactam clinical trials

Pharmacology for cilastatin sodium; imipenem; relebactam

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

US Patents and Regulatory Information for cilastatin sodium; imipenem; relebactam

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 cilastatin sodium; imipenem; relebactam

Country	Patent Number	Title	Estimated Expiration
Japan	2012214475
Canada	2712783
Denmark	2666774
Hungary	S2000023

Supplementary Protection Certificates for cilastatin sodium; imipenem; relebactam

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2231667	122020000034	Germany		PRODUCT NAME: RELEBACTAM ODER EIN MONOHYDRAT DAVON; NAT. REGISTRATION NO/DATE: EU/1/19/1420 20200213; FIRST REGISTRATION: EU EU/1/191420 20200213
2231667	2020/029	Ireland		PRODUCT NAME: RELEBACTAM OR A MONOHYDRATE THEREOF; REGISTRATION NO/DATE: EU/1/19/1420 20200217
2666774	SPC/GB20/031	United Kingdom		PRODUCT NAME: RELEBACTAM OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT.; REGISTERED: UK EU/1/19/1420 (NI) 20200217; UK PLGB 53095/0053 20200217
2666774	32/2020	Austria		PRODUCT NAME: RELEBACTAM, GEGEBENENFALLS IN DER FORM DES MONOHYDRATS, UND IMIPENEM.; REGISTRATION NO/DATE: EU/1/19/1420 (MITTEILUNG) 20200217

Market Dynamics and Financial Trajectory for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

Last updated: July 30, 2025

Introduction

The pharmaceutical landscape for antimicrobial agents, particularly beta-lactam antibiotics combined with beta-lactamase inhibitors, continues to evolve rapidly. Among these, the combination of cilastatin sodium, imipenem, and relebactam stands out as a significant candidate due to its broad-spectrum activity against multidrug-resistant pathogens. This analysis explores the current market forces, regulatory developments, competitive environment, and financial outlooks shaping the trajectory of this novel combination.

Pharmacological Profile and Clinical Significance

Cilastatin sodium acts as a competitive inhibitor of dehydropeptidase I, preventing the renal inactivation of imipenem, a carbapenem antibiotic with potent activity against Gram-positive and Gram-negative bacteria. Relebactam is a β-lactamase inhibitor that restores activity of imipenem against certain resistant strains, notably those producing KPC enzymes.

The combination offers a promising therapeutic option for complicated intra-abdominal infections, pneumonia, and other severe bacterial infections, especially as antimicrobial resistance (AMR) escalates globally. The increasing prevalence of resistant gram-negative bacteria has spurred regulatory agencies and healthcare providers to prioritize such agents.

Market Dynamics

Global Antimicrobial Resistance Crisis

Rising antimicrobial resistance remains the primary driver of market growth for this combination. The World Health Organization labels AMR as a fundamental threat, prompting governments and healthcare systems to adopt more aggressive antimicrobial stewardship and incentivize the development of novel agents [1].

Regulatory Approvals and Pipeline Advancements

Relebactam's regulatory journey has been pivotal. The U.S. Food and Drug Administration (FDA) approved the imipenem/cilastatin/relebactam combination (ReCarbrio) in 2019 for complicated urinary tract infections (cUTIs) and complicated intra-abdominal infections (cIAIs). Other regulatory sentiments in Europe and Asia are favorable, with ongoing pivotal trials supporting broader indications such as hospital-acquired bacterial pneumonia (HABP).

Competitive Landscape

The market features several broad-spectrum carbapenems combined with β-lactamase inhibitors, notably meropenem-vaborbactam and meropenem-relebactam. The competitive edge of imipenem/relebactam lies in its effectiveness against certain resistant strains and favorable pharmacokinetic profiles [2].

However, generic competition and the rapid pipeline of new antibiotics create pressures. Additionally, alternatives like cefiderocol, which can target extensively drug-resistant pathogens, threaten market share.

Pricing and Reimbursement Factors

Pricing strategies often rely on the drug’s clinical advantages over existing therapies. Relebactam's addition aims to justify premium pricing, especially in hospital settings managing resistant infections. Reimbursement policies in the U.S. and emerging markets substantially influence market penetration.

Market Adoption and Prescribing Trends

Hospitals and infectious disease specialists increasingly favor agents capable of combating carbapenem-resistant Enterobacteriaceae (CRE). Institutional procurement, formulary inclusion, and physician awareness are critical factors in rapid adoption.

Financial Trajectory

Revenue Projections

Initial revenues have been modest but growing, aligned with the drug's approval for specific indications. The market expects significant expansion as broader indications—like pneumonia and deep-seated infections—gain regulatory approval and physician familiarity increases [3].

A conservative estimate suggests that by 2025, annual global sales could reach several hundred million USD, considering current adoption trends, especially in North America and Europe.

Research and Development Investment

Expanding indications and optimizing formulations necessitate ongoing R&D investments. Companies are exploring fixed-dose combinations, pediatric formulations, and outpatient administration solutions, which could generate additional revenue streams.

Market Challenges and Risks

Market growth faces hurdles from:

• Emerging resistance that could diminish efficacy.
• Competition from novel agents and combination therapies.
• Regulatory delays and reimbursement hurdles in certain regions.

Partnerships and Licensing Deals

Strategic alliances with biotech firms and licensing agreements have supported pipeline expansion. These partnerships facilitate distribution in emerging markets and enable cost-sharing for R&D, impacting financial projections positively.

Future Outlook and Strategic Considerations

The financial trajectory hinges on clinical success, regulatory approvals beyond current indications, and effective market penetration strategies. Companies investing in post-marketing surveillance will enhance safety profiles, boosting prescriber confidence.

Emerging technologies, such as rapid diagnostic tools, can facilitate timely therapy initiation, increasing product adoption. Moreover, government incentives and push for antibiotic stewardship will encourage markets to favor novel agents, positively influencing revenue flows.

Key Factors Influencing Market and Financial Outcomes

• AMR Trends: The acceleration of drug-resistant infections sustains demand for effective antibiotics.
• Regulatory Landscape: Fast-track approvals and orphan drug designations in specific markets expedite access.
• Healthcare Infrastructure: Infection control practices and hospital protocols directly affect utilization.
• Competitive Innovation: Next-generation antibiotics and adjunct therapies could challenge current market share.
• Pricing and Reimbursement: Favorable policies are critical for widespread adoption.

Conclusion

The market for cilastatin sodium, imipenem, and relebactam embodies the dynamics of a high-stakes, rapidly evolving sector within antimicrobial therapeutics. While initial financial gains are promising, sustained growth depends on expanding indications, combating resistance, and navigating an increasingly competitive environment. Strategic investments in R&D, regulatory navigation, and market access remain essential drivers of long-term financial success.

---

Key Takeaways

• Growing Demand: Increasing antimicrobial resistance positions this combination as a critical treatment option, fueling market expansion.
• Regulatory Approvals: Early approvals for specific infections set the stage for future indications and revenue growth.
• Competitive Edge: Relebactam-enhanced carbapenems offer advantages over some rivals but face implicit competition from emerging agents.
• Pricing Dynamics: Premium pricing justified by clinical benefits must be balanced against healthcare budget constraints.
• Future Potential: Broader indications, innovative formulations, and strategic partnerships will be pivotal to maximizing profitability.

---

FAQs

1. What are the primary clinical indications for the cilastatin sodium, imipenem, and relebactam combination?
Primarily approved for complicated urinary tract infections and intra-abdominal infections, with potential expansion into hospital-acquired pneumonia and other severe bacterial infections.

2. How does relebactam enhance the efficacy of imipenem?
Relebactam inhibits specific β-lactamases, restoring imipenem's activity against resistant bacteria producing these enzymes, especially KPC-producing organisms.

3. What are the key competitors to this combination in the market?
Meropenem-vaborbactam, meropenem-relebactam (a direct competitor), and cefiderocol are among the main rivals, each with unique spectrum profiles.

4. What are the major challenges facing market growth for this drug combination?
Growing resistance patterns, competition from newer agents, pricing pressures, and regulatory hurdles are primary obstacles.

5. How can companies maximize the financial potential of this combination?
Through expanding indications, securing broader regulatory approvals, optimizing formulations, engaging in strategic partnerships, and ensuring favorable reimbursement pathways.

---

Sources
[1] WHO. Global Action Plan on Antimicrobial Resistance. 2015.
[2] Lambert, J. C., et al. “Relebactam: A novel beta-lactamase inhibitor for use in multidrug-resistant bacterial infections.” Expert Review of Anti-infective Therapy, 2020.
[3] EvaluatePharma. "The Future of Antibiotic Markets," 2022.