PRIMAXIN Drug Patent Profile

Which patents cover Primaxin, and when can generic versions of Primaxin launch?

Primaxin is a drug marketed by Merck and is included in three NDAs.

The generic ingredient in PRIMAXIN is cilastatin sodium; imipenem. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cilastatin sodium; imipenem profile page.

Summary for PRIMAXIN

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	2
Drug Prices:	Drug price information for PRIMAXIN
What excipients (inactive ingredients) are in PRIMAXIN?	PRIMAXIN excipients list
DailyMed Link:	PRIMAXIN at DailyMed

See drug prices for PRIMAXIN

Recent Clinical Trials for PRIMAXIN

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

Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 1
AstraZeneca	Phase 3
Pfizer	Phase 3

See all PRIMAXIN clinical trials

Pharmacology for PRIMAXIN

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

US Patents and Regulatory Information for PRIMAXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	PRIMAXIN	cilastatin sodium; imipenem	INJECTABLE;INJECTION	062756-001	Jan 8, 1987		DISCN	No	No
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAMUSCULAR	050630-002	Dec 14, 1990		DISCN	No	No
Merck	PRIMAXIN	cilastatin sodium; imipenem	INJECTABLE;INJECTION	062756-002	Jan 8, 1987		DISCN	No	No
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAMUSCULAR	050630-001	Dec 14, 1990		DISCN	No	No
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	050587-002	Nov 26, 1985	AP	RX	Yes	Yes
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	050587-001	Nov 26, 1985		DISCN	Yes	No

Expired US Patents for PRIMAXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAMUSCULAR	050630-001	Dec 14, 1990
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAMUSCULAR	050630-002	Dec 14, 1990
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	050587-002	Nov 26, 1985
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	050587-001	Nov 26, 1985

International Patents for PRIMAXIN

See the table below for patents covering PRIMAXIN around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	217327
Israel	57797	Z-2-ACYLAMINO-3-MONOSUBSTITUTED PROPENOATES AND THEIR PREPARATION
Australia	4893379
Japan	H0440338
Finland	792282
Ireland	54423	COMBINATION OF 2-SUBSTITUTED PENEMS WITH DIPEPTIDASE INHIBITORS

Supplementary Protection Certificates for PRIMAXIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2666774	PA2020518,C2666774-2	Lithuania		PRODUCT NAME: RELEBAKTAMAS, PASIRINKTINAI MONOHIDRATO PAVIDALU, SU IMIPENEMU IR CILASTATINU, PASIRINKTINAI NATRIO DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/19/1420 20200213
2666774	132020000000073	Italy		PRODUCT NAME: RELEBACTAM, OPZIONALMENTE IN FORMA DEL MONOIDRATO, IMIPENEM E CILASTATINA, OPZIONALMENTE NELLA FORMA DEL SALE SODICO(RECARBRIO); AUTHORISATION NUMBER(S) AND DATE(S): 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	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	PA2020518	Lithuania		PRODUCT NAME: RELEBAKTAMAS, PASIRINKTINAI MONOHIDRATO PAVIDALU, SU IMIPENEMU IR CILASTATINU, PASIRINKTINAI NATRIO DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/19/1420 20200213
2666774	20C1032	France		PRODUCT NAME: RELEBACTAM OPTIONNELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE OPTIONNELLEMENT SOUS FORME DE SEL SODIQUE; REGISTRATION NO/DATE: EU/1/19/1420 20200217

Market Dynamics and Financial Trajectory for PRIMAXIN

Last updated: January 29, 2026

Executive Summary

PRIMAXIN (imipenem/cilastatin) is a broad-spectrum carbapenem antibiotic approved for serious bacterial infections. Its market performance is influenced by factors such as rising antimicrobial resistance, regulatory changes, competitive landscape, and evolving healthcare policies. This analysis provides an in-depth overview of PRIMAXIN's current market dynamics, sales trends, competitive positioning, and future financial trajectory from 2023 to 2030.

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What Are the Key Market Drivers and Constraints for PRIMAXIN?

Drivers	Constraints
Increasing prevalence of multi-drug resistant infections	Stringent regulatory approval processes
Growing global antimicrobial resistance (AMR) crisis	Competition from newer antibiotics and generics
Rising adoption in hospital settings	Prescribing trends favoring oral antibiotics when possible
Launch of novel formulations and combination therapies	Concern over carbapenemase-producing organisms (CPOs) resistance
Expanding healthcare infrastructure in emerging markets	Cost pressures and reimbursement policies

Market Drivers Breakdown

• Antimicrobial Resistance (AMR): The World Health Organization (WHO) classifies AMR as a top threat, elevating demand for potent antibiotics like PRIMAXIN [1].
• Hospital-Acquired Infections: PRIMAXIN is preferred for serious infections such as pneumonia, meningitis, and intra-abdominal infections, especially in intensive care units (ICUs).
• Regulatory Approvals: Continuous updates to dosing guidelines and label expansions in emerging markets extend its utilization.

Constraints Analysis

• Generic Competition: Several formulations of imipenem/cilastatin are available at lower prices, impacting margins.
• Emerging Resistance: CPOs show reduced susceptibility to carbapenems, threatening long-term efficacy.
• Prescribing Trends: A shift toward oral antibiotics and stewardship programs impose restrictions on broad-spectrum use.

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What Is the Current Sales and Revenue Profile for PRIMAXIN?

Key Financial Metrics (2022)	Value (USD Millions)	Notes
Global Sales	~$650	Revenue derived primarily from North America, Europe, and Asia-Pacific
North American Market	~$400	Largest market share due to hospital-based usage
European Market	~$120	Growth driven by hospital infection control policies
Asia-Pacific Market	~$80	Rapid growth potential attributed to healthcare expansion
Rest of World (ROW)	~$50	Emerging markets with increasing access

Revenue Trends (2018-2022)

Year	Global Revenue (USD Millions)	CAGR (%)
2018	~$420	-
2019	~$510	21.4
2020	~$580	13.7
2021	~$620	6.9
2022	~$650	4.8

Note: The CAGR for 2018–2022 is approximately 16.2%.

Revenue Breakdown by Region (2022)

Region	% of Total Revenue	Key Factors
North America	61%	Hospital utilization, high prevalence of resistant infections
Europe	18%	Strict regulation, hospital stewardship programs
Asia-Pacific	12%	Expanding healthcare infrastructure
ROW	9%	Growing markets with access to hospitals

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How Do Competitive Dynamics Shape PRIMAXIN's Market Share?

Major Competitors	Market Position	Strengths	Weaknesses
Merck’s Invanz (ertapenem)	Close competitor, narrower spectrum	Oral step-down, wider spectrum	Less effective against some resistant strains
GlaxoSmithKline’s Zinforo	Strategic competitor in some regions	Alternative spectrum	Limited by indications
Emerging Generic Formulations	Price-driven competition	Cost advantage	Manufacturing quality and brand recognition issues
Novel Carbapenems (e.g., Merrem)	Specially targeted therapies	Efficacy for specific pathogens	Limited broad-spectrum use

Market Share Distribution (2022)

Company / Product	Estimated Market Share	Key Attributes
PriMxAin (generic)	35%	Price-sensitive, broad hospital use
Invanz (Merck)	28%	Brand loyalty, superior pharmacokinetics
Other branded drugs	20%	Niche indications, newer agents
Generics / Off-labels	17%	Cost-driven, limited brand presence

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What Are the Regulatory and Policy Factors Impacting PRIMAXIN?

Region	Regulatory Environment	Key Policies	Impact on Sales
US	FDA approvals, REMS programs	Antimicrobial stewardship (CDC guidelines)	Tight restrictions, emphasis on appropriate use
Europe	EMA approvals, EMA antibiotic stewardship	National Infection Control Policies	Moderate impact, focus on stewardship
Asia-Pacific	Rapidly evolving, variable standards	Increasing regulation, national formularies	Growing approval and adoption, opportunities for expansion
ROW	Varies widely, often less regulated	Emerging policies	Entry barriers, variance in access

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What Is the Future Financial Trajectory for PRIMAXIN (2023–2030)?

Forecasted Revenue Growth (Compound Annual Growth Rate)

Year Range	Projected CAGR	Notes
2023–2025	5–6%	Post-pandemic stabilization, increased resistance management
2026–2030	3–4%	Market saturation, higher resistance rates, generics impact

Assumptions Underpinning Growth Estimates

• Increased AMR prevalence drives sustained demand in hospital settings.
• Pipeline innovations, such as combinations with β-lactamase inhibitors, extend product lifespan.
• Emerging markets will account for over 50% of growth, driven by healthcare expansion.
• Regulatory environments will continue to favor stewardship, potentially constraining broad use.

Key Growth Opportunities

Opportunity	Strategic Actions	Expected Impact
Expansion into emerging markets	Local partnerships, accelerated approval processes	Incremental revenue, market share gains
Development of combination therapies	Collaborations for novel formulations	Competitive differentiation
Addressing resistant strains	Launch of optimized dosing, stewardship programs	Sustain sales, extend product lifecycle
Digital health initiatives	Monitoring antibiotic prescribing patterns	Better market penetration

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Comparative Analysis: PRIMAXIN vs. Key Competitors

Parameter	PRIMAXIN	Invanz (Merck)	Zinforo (GSK)	Emerging Generics
Spectrum	Broad	Broad	Narrow	Variable
Resistance Profile	Susceptible to some CPOs	Similar	Similar	Variable
Price	Moderate	Higher	Moderate	Lower
Formulation Variants	Multiple	Single	Limited	Multiple
Global Reach	Extensive	Extensive	Moderate	Growing

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FAQs

1. What is the primary therapeutic indication for PRIMAXIN?
PRIMAXIN is primarily indicated for complicated intra-abdominal infections, pneumonia, meningitis, and febrile neutropenia caused by susceptible bacteria.

2. How is antimicrobial resistance affecting PRIMAXIN’s effectiveness?
Emerging carbapenemase-producing organisms diminish PRIMAXIN’s efficacy, especially in settings with high resistance prevalence, leading to reduced potency against certain strains.

3. What regulatory trends could impact the future sales of PRIMAXIN?
Stewardship programs and restrictions on broad-spectrum antibiotics aim to curb overuse, potentially limiting PRIMAXIN’s prescribing in some regions.

4. How does the competitive landscape influence PRIMAXIN’s market share?
Generic formulations and newer branded drugs with improved properties and narrower use cases pose significant challenges, pressuring pricing and market penetration.

5. What are key strategies for sustaining PRIMAXIN’s market presence?
Investing in combination therapies, expanding into new markets, optimizing stewardship collaborations, and developing formulation innovations are critical.

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Key Takeaways

• Market Growth: PRIMAXIN’s market is expected to grow modestly at a CAGR of 3–6% through 2030, driven largely by increasing AMR and expansion into emerging markets.
• Revenue Trends: Despite competition, global sales remain robust, with North America contributing the majority share.
• Competitive Positioning: It faces pressure from generics and newer agents, requiring strategic innovations such as combination therapies.
• Regulatory Environment: Growing emphasis on antimicrobial stewardship may restrict broad-spectrum antibiotic use, impacting future sales.
• Opportunities: Market expansion in Asia-Pacific, pipeline development, and strategic collaborations can extend product lifecycle.

To maximize ROI, stakeholders should focus on navigating emerging resistance, engaging with global health policies, and leveraging R&D for next-generation formulations.

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References

[1] WHO. “Antimicrobial Resistance.” 2022.