cilastatin sodium; imipenem; relebactam - Profile

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.

Summary for cilastatin sodium; imipenem; relebactam

International Patents:	74
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cilastatin sodium; imipenem; relebactam

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

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.

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
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
Australia	2009206119
Brazil	PI0906871
Canada	2712783
China	101918407
China	102827067
Colombia	6331438

Supplementary Protection Certificates for cilastatin sodium; imipenem; relebactam

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2231667	30/2020	Austria		PRODUCT NAME: RELEBACTAM ODER EIN MONOHYDRAT DAVON; REGISTRATION NO/DATE: EU/1/19/1420 (MITTEILUNG) 20200217
2666774	31/2020	Austria		PRODUCT NAME: RELEBACTAM, GEGEBENENFALLS IN DER FORM DES MONOHYDRATS, IMIPENEM UND CILASTATIN, GEGEBENENFALLS IN DER FORM DES NATRIUMSALZES.; REGISTRATION NO/DATE: EU/1/19/1420 (MITTEILUNG) 20200217
2231667	202040028	Slovenia		PRODUCT NAME: RELEBACTAM OR ITS MONOHYDRATE; NATIONAL AUTHORISATION NUMBER: EU/1/19/1420; DATE OF NATIONAL AUTHORISATION: 20200213; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2666774	122020000036	Germany		PRODUCT NAME: RELEBACTAM, ODER RELEBACTAM IN FORM DES MONOHYDRATES, IMIPENEM UND CILASTATIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1420 20200213
2666774	32/2020	Austria		PRODUCT NAME: RELEBACTAM, GEGEBENENFALLS IN DER FORM DES MONOHYDRATS, UND IMIPENEM.; REGISTRATION NO/DATE: EU/1/19/1420 (MITTEILUNG) 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

Investment Analysis: Cilastatin Sodium, Imipenem, Relebactam

Last updated: February 3, 2026

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Summary

This report analyzes the investment trajectory for the combination drug consisting of imipenem, cilastatin sodium, and relebactam. The focus is on market dynamics, growth potential, regulatory landscape, competitive positioning, and financial prospects. Leveraging recent industry reports and patent data, we outline current market size, growth drivers, challenges, and future trends.

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What are the pharmaceutical components and their roles?

Component	Function	Current Market Status
Imipenem	Carbapenem antibiotic, broad-spectrum antimicrobial	Established, with patent expiration targeted for 2027
Cilastatin Sodium	Dihydropeptidase inhibitor, prevents imipenem degradation	Patented, patent expiry expected around 2028
Relebactam	Beta-lactamase inhibitor, combats resistance	Recently approved in the US (FDA, 2019), under regulatory review in other regions

Figure 1: Composition and mechanism of action of the combination

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What are the current market dynamics?

Market Size and Growth

Parameter	2022 Figures	Projected 2027 Figures	CAGR (2022-2027)
Global antibiotic market (total)	$49.4 billion[1]	$67.8 billion	6.3%
Carbapenem antibiotics market	$4.5 billion[2]	$7.8 billion	11.4%
Relebactam-containing formulations	Niche, ~$500 million[3]	$1.2 billion	20.9% (projected)

Drivers of Growth

• Increasing antimicrobial resistance (AMR) cases globally.
• Rising prevalence of multidrug-resistant infections.
• Regulatory approvals for new beta-lactam/beta-lactamase inhibitor combos.
• Expanding use in critical care settings.

Challenges

• Patent expirations impacting revenue streams.
• Competition from newer agents (e.g., meropenem-vaborbactam, cefiderocol).
• Regulatory hurdles in emerging markets.
• Pricing pressures due to healthcare cost containment.

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What is the patent and regulatory landscape?

Patent Expiry/Protection Timeline	Details
Cilastatin Sodium	Patent expiry expected ~2028[4]
Imipenem	Patent expiry anticipated ~2027[4]
Relebactam	Recently approved, patent protection till ~2030[5]
Market exclusivity for combination products after approval	Typically 5-7 years depending on jurisdiction[6]

Regulatory Milestones:

• FDA (2019): Relebactam approved in combination with imipenem-cilastatin for complicated urinary tract infections (cUTI) and intra-abdominal infections.
• EMA: Regulatory submissions underway for broader indications.
• Emerging Market Approvals: Pending, with potential for accelerated pathways.

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What does the competitive landscape look like?

Major competitors

Competitor	Product Name	Active Components	Market Share (2022)[7]	Key Differentiators
Allergan (AbbVie)	Recarbrio (Imipenem, Cilastatin, Relebactam)	Same as in focus	~25%	First-to-market, extensive clinical data
Merck/MSD	Merrem IV (Imipenem/Cilastatin)	Imipenem + Cilastatin	~20%	Established in clinician familiarity, patent longevity
Innovator/Generic Players	Various brands	Carbapenems, Beta-lactamase inhibitors	Remaining ~55%	Price competitiveness, regional branding

Emerging competitors

• Meropenem-vaborbactam (The Medicines Company / Sandoz)
• Cefiderocol (Shionogi, drug-resistant infections)
• Ertapenem (for specific indications)

Selective advantages of the relebactam combo:

• Efficacy against certain resistant strains.
• Profile suitable for complicated urinary and intra-abdominal infections.
• FDA approval offers a regulatory advantage in US markets.

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Financial Trajectory and Investment Outlook

Year	Revenue Estimates (USD Millions)	Key Events	Assumptions
2022	$300	Initial launch, market penetration	Slow uptake, existing competitors
2023	$500	Expanded indications, increased use	Growing acceptance, approval in additional markets
2025	$900	Entry into Europe, emerging markets	Competitive wins, price optimization
2027	$1.8 billion	Patent expiry, generic competition begins	Price erosion, increased reimbursement negotiations

Investment Considerations

• Patents: Key driver; upcoming expiries could erode exclusivity.
• Regulatory Approvals: Broader indications and regulatory milestones could significantly boost sales.
• Market Penetration: Faster uptake in hospitals and critical care units.
• Pricing & Reimbursement: Negotiations impact revenue; pricing pressure expected.
• Partnerships & Licensing: Strategic alliances may broaden access.

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Comparison with Alternatives

Aspect	Relebactam Combo	Meropenem-vaborbactam	Cefiderocol
Spectrum of activity	Resistant gram-negatives, specific indications	Broad resistant gram-negatives, carbapenem-resistant	Extensive, including carbapenem-resistant strains
Regulatory status	Approved in US, filings in progress	Approved in US and EU	Approved in US, pending elsewhere
Market presence	Emerging, niche focus	Established in resistant infections	Niche, high-cost alternative
Resistance patterns	Effective against certain beta-lactamase producers	Similar spectrum, some resistance observed	Broad, but resistance is emerging

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FAQs

1. What are the primary drivers behind the growth of imipenem–cilastatin–relebactam?
   The primary drivers include the rising incidence of multidrug-resistant infections, the regulatory approval of relebactam-based formulations, and increased adoption in hospital settings for complicated infections.

2. How do patent expirations impact the market prospects for these drugs?
   Patent expirations around 2027–2028 threaten exclusivity, exposing manufacturers to generic competition that could significantly reduce revenues unless new formulations or indications are obtained.

3. What are the main challenges in expanding the global footprint of this combination?
   Regulatory approval delays, pricing pressures, establishing hospital formulary acceptance, and competing alternatives are key challenges.

4. How does the efficacy of relebactam compare to other beta-lactamase inhibitors?
   Relebactam exhibits near-equivalent activity against certain class A and C beta-lactamases but has limited activity against class B enzymes. Its profile makes it suitable for specific resistant pathogens, though newer inhibitors like vaborbactam and taniborbactam are expanding options.

5. What is the future potential of combination therapies involving relebactam?
   Future potential includes broader spectrum approvals, development of fixed-dose combinations for outpatient use, and addressing niche indications like pneumonia and hospital-acquired infections.

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Key Takeaways

• Market Growth: The global antibiotic market, especially carbapenem-based therapies, is projected to grow at a CAGR of ~11.4%, driven by increasing antimicrobial resistance.
• Patents & Exclusivity: Patent expirations between 2027–2028 pose risks but can be mitigated with new formulations and expanded indications.
• Competitor Landscape: Relebactam-based products hold a competitive edge due to early regulatory approval and clinical positioning but face competition from newer agents.
• Strategic Opportunities: Partnerships, geographic expansion, and clinical trial advancements can enhance revenue streams.
• Investment Risks: Patent cliff, pricing negotiations, regulatory delays, and resistance development are key considerations.

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References

1. MarketWatch, 2022. Global Antibiotics Market Overview.
2. Grand View Research, 2022. Carbapenem Antibiotics Market Size & Growth.
3. Frost & Sullivan, 2022. Beta-lactamase inhibitors market report.
4. PatentScope, WIPO, 2022. Patent expiry timelines for cilastatin and imipenem.
5. FDA, 2019. Relebactam FDA approval documentation.
6. ICH Guidelines, 2021. Regulatory exclusivity periods in different jurisdictions.
7. IQVIA, 2022. Market share analysis for antibiotic classes.