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-four patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

International Patents:	74
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

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.

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
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			Y	Y

International Patents for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

Country	Patent Number	Title	Estimated Expiration
Poland	2666774
Japan	5422020
Serbia	53052
Lithuania	PA2020516
South Korea	20100130176
European Patent Office	2666774

Supplementary Protection Certificates for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2666774	2020024	Norway		PRODUCT NAME: KOMBINASJON AV RELEBAKTAM EVENTUELT I FORM AV MONOHYDRAT, IMIPENEM OG CILASTATIN, EVENTUELT I FORM AV NATRIUMSALT; REG. NO/DATE: EU/1/19/1420 20200219
2666774	PA2020517	Lithuania		PRODUCT NAME: RELEBAKTAMAS, PASIRINKTINAI MONOHIDRATO PAVIDALU, IR IMIPENEMAS; REGISTRATION NO/DATE: EU/1/19/1420 20200213
2231667	PA2020516	Lithuania		PRODUCT NAME: RELEBAKTAMAS ARBA JO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1420 20200213
2666774	LUC00167	Luxembourg		PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE, EVENTUELLEMENT SOUS FORME DE SEL DE SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217
2231667	C20200021 00336	Estonia		PRODUCT NAME: RELEBAKTAAM;REG NO/DATE: EU/1/19/1420 17.02.2020
2666774	2020C/523	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE

Market Dynamics and Financial Trajectory for Cilastatin Sodium, Imipenem, and Relebactam

Last updated: February 20, 2026

What is the current landscape for cilastatin sodium, imipenem, and relebactam?

Cilastatin sodium, imipenem, and relebactam form a combination therapy targeting multidrug-resistant bacterial infections. Imipenem is a carbapenem antibiotic; cilastatin inhibits renal dehydropeptidase to prevent imipenem degradation; relebactam is a beta-lactamase inhibitor enhancing efficacy against resistant bacteria.

How are these drugs positioned in the global pharmaceutical market?

Market size and growth

• The global antibiotic market was valued at approximately USD 49 billion in 2021, expected to reach USD 75 billion by 2030, registering a CAGR of around 6.0% [1].
• Carbapenems account for a significant share due to rising resistance, especially in hospital-acquired infections.
• The segment of beta-lactam/beta-lactamase inhibitor combinations, including relebactam, is expanding faster, with a CAGR estimated around 7%-8% over the next decade [2].

Key players and development status

• No current FDA approval for the imipenem/relebactam combination; developed by Merck & Co.
• Imipenem/cilastatin (Primaxin) has longstanding presence, with over 30 years on the market.
• Relebactam is in late clinical development stages, with pivotal trials completed for complicated urinary tract infections (cUTI), intra-abdominal infections, and hospital-acquired pneumonia (HAP).

Clinical pipeline and regulatory trends

Drug combination	Development stage	Key milestones
Imipenem/cilastatin	Approved since 1985	Established market presence
Imipenem/relebactam	Phase 3 completed, pending FDA submission	Data show non-inferiority for bacterial infections; regulatory approval expected by 2023-2024
Relebactam monotherapy	Phase 2/3	Clinical trials targeting resistant bacterial strains

What are the drivers impacting the financial trajectory?

Rising antibiotic resistance

• Growing prevalence of carbapenem-resistant Enterobacteriaceae (CRE) strains increases demand for combination therapies with beta-lactamase inhibitors.
• WHO classifies CRE as a critical priority pathogen, driving regulatory focus and potential market expansion [3].

Regulatory incentives and barriers

• Fast-track designations may expedite approval; however, unmet market needs for new antibiotics often face pricing and reimbursement challenges.
• Limited market exclusivity, with patent expirations for imipenem/cilastatin occurring around 2030, influence revenue lifespan.

Healthcare spending trends

• Global healthcare expenditures for antimicrobial agents are increasing, particularly in regions with rising hospital-acquired infection rates.
• In the US, antimicrobial spending exceeded USD 3 billion in 2020, with room for growth in resistant infection segments [4].

Competitive landscape

• Alternative therapies include meropenem-vaborbactam, cefiderocol, and aztreonam-avibactam, competing for similar indications.
• Strategic collaborations and licensing agreements influence market access and pricing strategies.

What financial projections are available?

Period	Revenue estimates for imipenem/relebactam	Assumptions
2023	USD 200-300 million	Launch in US and key European markets; adoption in hospitals
2025	USD 500-700 million	Expanded indications; global distribution
2030	USD 1-2 billion	Market penetration; resistance-driven demand

Note: These projections depend heavily on approval timelines, clinical success, and competitive responses.

What risks and opportunities exist?

Risks

• Delays in regulatory approval or setbacks in clinical trials.
• Market entry of newer agents with broader spectrums or longer durations of patent exclusivity.
• Pricing pressures amid increased scrutiny over antibiotic stewardship and reimbursements.

Opportunities

• Growing unmet needs for resistant bacterial infections.
• Expansion into hospital formulary adoption driven by resistance trends.
• Potential for combination with other novel agents to broaden spectrum.

Summary of key points

• The market for imipenem-relebactam features rapid growth, driven by antimicrobial resistance.
• Relebactam's clinical development is nearing commercialization, with potential for substantial revenue.
• Existing revenue from imipenem/cilastatin remains stable but faces patent expiration threats.
• Pricing depends on regulatory approvals, clinical outcomes, and market uptake.
• Competition from other beta-lactamase inhibitors influences market share and revenue potential.

Key Takeaways

• The expansion of beta-lactamase inhibitor combinations addresses a critical market need but faces regulatory and competitive hurdles.
• Resistance dynamics and healthcare investment levels significantly influence market growth.
• The revenue trajectory for imipenem/relebactam could reach USD 1-2 billion by 2030 with successful commercialization.
• Patent expirations and emerging competitors require strategic planning for sustained profitability.
• Clinical trial results and regulatory decisions will be decisive in determining future market share.

FAQs

1. What are the main indications for imipenem/relebactam?
Primarily complicated urinary tract infections, intra-abdominal infections, and hospital-acquired pneumonia.

2. When is FDA approval expected for imipenem/relebactam?
Regulatory submission expected in 2023, with approval possible by 2024.

3. What are the key competitive agents?
Meropenem-vaborbactam, cefiderocol, and aztreonam-avibactam.

4. How does resistance impact market growth?
Rising resistance to existing antibiotics increases demand for new combinations like relebactam, fueling market expansion.

5. What factors could limit revenue growth?
Pricing pressures, patent expiry of key drugs, delays in approval, and emergence of new competitors.

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References

[1] Grand View Research. (2022). Antibiotics Market Size, Share & Trends Analysis Report.
[2] Markets and Markets. (2022). Antibiotics Market by Type, Application, and Region.
[3] World Health Organization. (2017). Global priority list of antibiotic-resistant bacteria.
[4] IQVIA. (2021). Global Use of Medicines.

Note: Data and estimates are based on current industry reports and may evolve with future clinical or regulatory developments.