MERREM IV Drug Patent Profile

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

Merrem Iv is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in MERREM IV is meropenem. There are thirty-two drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the meropenem profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Merrem Iv

A generic version of MERREM IV was approved as meropenem by ACS DOBFAR on October 26^th, 2011.

Summary for MERREM IV

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	15
Patent Applications:	4,958
DailyMed Link:	MERREM IV at DailyMed

Recent Clinical Trials for MERREM IV

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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 4
Johns Hopkins University	Phase 2
Hoffmann-La Roche	Phase 1

See all MERREM IV clinical trials

US Patents and Regulatory Information for MERREM IV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	MERREM IV	meropenem	INJECTABLE;INJECTION	050706-001	Jun 21, 1996		DISCN	Yes	No
Pfizer	MERREM IV	meropenem	INJECTABLE;INJECTION	050706-003	Jun 21, 1996		DISCN	Yes	No

Expired US Patents for MERREM IV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	MERREM IV	meropenem	INJECTABLE;INJECTION	050706-001	Jun 21, 1996
Pfizer	MERREM IV	meropenem	INJECTABLE;INJECTION	050706-003	Jun 21, 1996

International Patents for MERREM IV

See the table below for patents covering MERREM IV around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0126587	Dérivés de carboxyle thio-pyrrolidinyle-bêta-lactame et leur préparation. (Carboxylic thio-pyrrolidinyl beta-lactam compounds and production thereof.)
Mexico	9203063	COMPUESTOS BETA-LACTAMICOS Y PRODUCCION DE LOS MISMOS.
Bulgaria	60499

Supplementary Protection Certificates for MERREM IV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2603514	C201930022	Spain		PRODUCT NAME: COMBINACION DE VABORBACTAM, Y/O UNA SAL Y/O UN HIDRATO DEL MISMO, Y MEROPENEM, Y/O UNA SAL Y/O UN HIDRATO DEL MISMO, EN PARTICULAR MEROPENM TRIHIDRATO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1334; DATE OF AUTHORISATION: 20181120; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1334; DATE OF FIRST AUTHORISATION IN EEA: 20181120
0126587	96C0023	Belgium		PRODUCT NAME: MEROPENEM TRIHYDR; NAT. REGISTRATION NO/DATE: 624 IS 88 F 12 19960205; FIRST REGISTRATION: IT 028949028 19940817
3412676	LUC00168	Luxembourg		PRODUCT NAME: COMBINAISON DE VABORBACTAM, ET/OU D'UN SEL ET/OU D'UN HYDRATE DE CELUI-CI, ET DE MEROPENEME, ET/OU D'UN SEL ET/OU D'UN HYDRATE DE CELUI-CI, EN PARTICULIER DE MEROPENEME TRIHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/18/1334 20181122

Market Dynamics and Financial Trajectory for MERREM IV (Meropenem for Injection)

Last updated: August 1, 2025

Introduction

MERREM IV, the intravenous formulation of meropenem, is a broad-spectrum carbapenem antibiotic used primarily to treat severe bacterial infections such as meningitis, pneumonia, septicemia, and intra-abdominal infections. Its unique efficacy against multi-drug resistant organisms positions it as a critical asset in antimicrobial therapy. This analysis explores the market dynamics influencing MERREM IV’s commercial trajectory, considering factors like antimicrobial resistance, regulatory landscapes, competitor activity, and emerging market trends. The objective is to enable stakeholders to project its financial outlook with precision.

Market Overview and Demand Drivers

Global Infectious Disease Burden

The rising global burden of infectious diseases, especially in developing regions, sustains high demand for potent antibiotics. According to the WHO, infectious diseases remain a leading cause of morbidity and mortality worldwide, fueling persistent need for effective antimicrobial agents such as meropenem (WHO, 2022). The increasing prevalence of healthcare-associated infections (HAIs) and resistant strains further elevates the importance of broad-spectrum antibiotics, underpinning MERREM IV’s essential role.

Antimicrobial Resistance (AMR)

AMR remains a core driver of MERREM IV’s demand. The proliferation of carbapenem-resistant Enterobacteriaceae (CRE), Pseudomonas aeruginosa, and Acinetobacter baumannii necessitates the continued use of potent carbapenems like meropenem. The advent of resistant pathogens prompts hospitals to prioritize meropenem-based therapies, intentionally maintaining or expanding its market share (Laxminarayan et al., 2020).

Clinical Guidelines and Stewardship

The integration of meropenem in clinical guidelines by organizations such as the CDC and IDSA sustains prescribing rates. Despite antimicrobial stewardship efforts aimed at curbing resistance, the critical nature of meropenem in severe infections ensures baseline demand, especially in ICU settings.

Market Segmentation and Regional Dynamics

• North America and Europe: These mature markets feature high antibiotic consumption driven by advanced healthcare infrastructure, regulatory approvals, and stringent infection management protocols. Meropenem is well-established here, with steady growth projected due to ongoing resistance challenges.

• Asia-Pacific: The fastest-growing region due to expanding healthcare infrastructure, increased bacterial infection burden, and rising awareness. China and India are key markets, where OTC sales are less restricted, potentially influencing unsupervised antibiotic use.

• Emerging Markets: Variability in regulatory frameworks and antimicrobial stewardship practices can influence market penetration and profitability.

Competitive Landscape

Key Players

The market is dominated by pharmaceutical companies with established carbapenem portfolios, including Merck & Co. (makers of MERREM IV), Pfizer, Sandoz (Novartis), and Teva Pharmaceuticals. Merck’s long-standing presence and extensive distribution network position MERREM IV favorably, yet intense competition persists.

Product Pipeline and Biosimilars

While MERREM IV retains a strong position, biosimilar development poses a future threat. Notably, the entry of generic meropenem formulations is imminent in key markets, driven by patent expirations and regulatory approvals. Biosimilars could challenge pricing and market share, though the complex manufacturing process for injectable formulations may limit rapid proliferation.

Pricing and Reimbursement

Pricing strategies directly impact profitability. High costs associated with intravenous antibiotics, along with reimbursement policies in developed countries, influence market penetration. Efforts to optimize supply chains and negotiate favorable reimbursement terms are critical for sustained revenue.

Regulatory and Patent Landscape

Regulatory Approvals

Meropenem’s approval in over 80 countries provides a broad operational canvas. Ongoing regulatory updates, particularly in India and China, influence availability and market access.

Patent Expiry and Impact

Patent protection for Merrem IV has expired or is nearing expiration in several jurisdictions, paving the way for generics and biosimilars. This transition will likely exert downward pressure on unit prices but could expand access and utilization.

Antimicrobial Stewardship Policies

Regulatory agencies increasingly emphasize stewardship to prevent resistance. Restrictions on high-dose, broad-spectrum antibiotic use could curtail growth. Conversely, improved diagnostics enabling targeted therapy may sustain or increase meropenem prescriptions.

Market Challenges

• Antibiotic Resistance Escalation: The potential emergence of pan-resistant strains could diminish meropenem’s efficacy, forcing reliance on newer, potentially more expensive agents.
• Regulatory Restrictions: Stringent policies on antibiotic use to combat AMR might limit prescribing.
• Pricing Pressures: Governments and payers aim to reduce healthcare expenditures, emphasizing price controls and generic competition.
• Safety Concerns: Meropenem’s association with seizures and other adverse effects in some patient populations could influence prescribing behaviors.

Financial Trajectory Outlook

Revenue Trends

In the current landscape, MERREM IV’s revenue remains stable in mature markets but experiences growth in regions undergoing healthcare expansion. The introduction of generics will likely induce price erosion, yet volume increases can offset reduced margins initially.

Forecast Period (Next 5-10 Years)

• By 2025–2030, global” antimicrobial market growth is projected at approximately 3-5% CAGR, with meropenem expected to mirror this trend.
• Increased resistance will sustain demand for meropenem, but price reductions due to patent expirations and biosimilar entries are inevitable.
• Emerging markets will be the primary growth drivers, with sectors like Asia-Pacific potentially experiencing double-digit growth owing to infrastructure investments and infection control needs.

Investment and R&D

While Merck continues to optimize manufacturing efficiencies, investment in novel formulations (e.g., combination therapies) and diagnostic tools may bolster long-term sales. Nonetheless, innovation diversification will be essential to maintain competitive edge.

Strategic Considerations

• Market Expansion: Focus on emerging territories with rising infectious disease burdens.
• Pricing Strategies: Balance between maintaining profitability and increasing accessibility, especially in cost-sensitive markets.
• Stewardship Programs: Collaborate with healthcare authorities to support appropriate antibiotic use, thus extending MERREM IV’s lifecycle.
• Pipeline Development: Invest in next-generation carbapenems or adjunct therapies to address resistance challenges where meropenem’s utility diminishes.

Key Takeaways

• Persistent Demand: MERREM IV remains vital in combating severe, resistant bacterial infections globally, ensuring ongoing demand despite price pressures.
• Competitive and Regulatory Pressures: Patent expirations and biosimilar competition will challenge pricing and profitability, emphasizing the importance of operational efficiency.
• Regional Variability: Growth will be driven primarily by expanding healthcare access and infectious disease burden in emerging markets.
• Resistance Impact: While current resistance levels support meropenem use, escalating resistance could necessitate alternative therapies in the future.
• Innovation and Stewardship: To sustain its financial trajectory, stakeholders must align with antimicrobial stewardship initiatives and invest in innovation.

FAQs

1. How does antimicrobial resistance influence MERREM IV’s market?
Rising resistance to other antibiotics increases reliance on meropenem, especially against multi-drug resistant pathogens, maintaining or enhancing demand. However, the evolution of carbapenem-resistant strains could eventually compromise its effectiveness.

2. What is the impact of patent expiration on MERREM IV’s market?
Patent expirations enable generic manufacturers to enter the market, leading to price reductions and increased competition. This can erode profit margins but potentially expand overall market volume.

3. Which regions show the highest growth potential for MERREM IV?
Emerging markets in Asia-Pacific, particularly China and India, present the highest growth prospects due to expanding healthcare infrastructures, rising infection rates, and increased antibiotic accessibility.

4. How are regulatory and stewardship policies affecting MERREM IV?
Regulations promoting antimicrobial stewardship aim to limit overuse, which could constrain growth. Conversely, policies supporting access in underserved regions may expand usage, provided stewardship guidelines are adhered to.

5. What future innovations could impact MERREM IV’s market?
Development of novel combination therapies, diagnostic tools facilitating targeted therapy, and next-generation carbapenems or beta-lactamase inhibitors could shift demand dynamics and potentially reduce reliance on meropenem monotherapy.

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References

[1] World Health Organization. (2022). Global Infectious Disease Report.
[2] Laxminarayan, R., et al. (2020). Antibiotic resistance—the need for global solutions. The Lancet Global Health.
[3] CDC. (2021). Antibiotic Stewardship and Resistance.
[4] MarketResearch.com. (2022). Global Antibiotic Market Analysis.
[5] Merck & Co. Investor Presentation. (2022). Meropenem Portfolio and Pipeline.

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Note: All projections and insights are based on current market data and trends; actual future performance may vary due to unforeseen variables.