ERTAPENEM SODIUM - Generic Drug Details

What are the generic drug sources for ertapenem sodium and what is the scope of patent protection?

Ertapenem sodium is the generic ingredient in two branded drugs marketed by Acs Dobfar Spa, Eugia Pharma, Gland, Qilu Antibiotics, Savior Lifetec Corp, Sun Pharm, and Msd Sub Merck, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for ertapenem sodium. Seventeen suppliers are listed for this compound.

Summary for ERTAPENEM SODIUM

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	12
Patent Applications:	705
What excipients (inactive ingredients) are in ERTAPENEM SODIUM?	ERTAPENEM SODIUM excipients list
DailyMed Link:	ERTAPENEM SODIUM at DailyMed

Recent Clinical Trials for ERTAPENEM SODIUM

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
Albany College of Pharmacy and Health Sciences	Phase 4
Merck Sharp & Dohme Corp.	Phase 4

See all ERTAPENEM SODIUM clinical trials

Pharmacology for ERTAPENEM SODIUM

Drug Class

Penem Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for ERTAPENEM SODIUM

J01DH	Carbapenems
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for ERTAPENEM SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INVANZ	Injection	ertapenem sodium	1 g/vial	021337	1	2012-12-21

US Patents and Regulatory Information for ERTAPENEM SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	209145-001	May 2, 2023		DISCN	No	No
Eugia Pharma	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	209133-001	Jun 25, 2018	AP	RX	No	No
Gland	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	212040-001	Mar 26, 2021	AP	RX	No	No
Acs Dobfar Spa	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	208790-001	Apr 16, 2018	AP	RX	No	No
Qilu Antibiotics	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	218067-001	Oct 31, 2024	AP	RX	No	No
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	AP	RX	Yes	Yes
Savior Lifetec Corp	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	207647-001	Mar 19, 2019	AP	RX	No	No

Expired US Patents for ERTAPENEM SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	5,478,820*PED
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	7,342,005*PED
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	5,952,323*PED
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	5,652,233*PED

Market Dynamics and Financial Trajectory for Ertapenem Sodium

Last updated: July 27, 2025

Introduction

Ertapenem sodium, a broad-spectrum carbapenem antibiotic, has become an essential agent in treating various complicated bacterial infections, including intra-abdominal, skin, soft tissue, and genitourinary infections. Its unique pharmacological profile, including once-daily dosing and enhanced stability, has positioned it favorably within hospital and outpatient antimicrobial stewardship programs. This analysis explores the intricate market dynamics and financial trajectory shaping the future of ertapenem sodium, emphasizing key healthcare trends, competitive landscape, regulatory factors, and economic considerations impacting its market positioning.

Market Overview

Global Market Size and Growth Trends

The global antibiotic market, valued at approximately USD 48 billion in 2021, is projected to grow steadily, driven by increasing incidence of bacterial infections, rising antibiotic resistance, and expanding healthcare infrastructure globally. Within this space, carbapenems represent a significant segment, with ertapenem accounting for a notable share owing to its advantages over other broad-spectrum antibiotics [1].

Market forecasts suggest an annual growth rate of 4-6% for carbapenems, with ertapenem specifically projected to experience a compounded annual growth rate (CAGR) of roughly 5% over the next five years. The Asia-Pacific region is anticipated to be the fastest-growing market, attributed to expanding healthcare access, rising infection rates, and increased adoption of modern antimicrobial therapies.

Key Revenue Drivers

1. Hospital-Acquired Infections (HAIs): The rising prevalence of HAIs such as pneumonia, complicated urinary tract infections (cUTIs), and intra-abdominal infections positions ertapenem as a crucial therapeutic option.
2. Antimicrobial Stewardship Programs: The shift towards using targeted, broad-spectrum agents like ertapenem over less effective antibiotics is fueling demand.
3. Regulatory Approvals and Indications Expansion: Updated approvals for new indications or formulations can boost usage.
4. Rising Antibiotic Resistance: The proliferation of resistant bacteria necessitates novel and potent agents like ertapenem, indirectly driving market growth.

Market Dynamics

Competitive Landscape

Ertapenem faces competition primarily from other carbapenems such as meropenem and imipenem, alongside newer agents like meropenem-vaborbax and novel beta-lactam/beta-lactamase inhibitor combinations. Major pharmaceutical players include Merck (known for Invanz), Pfizer, and generic manufacturers, with a growing influx of biosimilars and generics poised to influence market dynamics.

The patent expiry of brand-name ertapenem formulations is imminent, prompting an acceleration in generic entry, which could significantly reduce prices and impact overall profitability.

Regulatory Environment

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) oversee approvals, safety, and efficacy standards. Recent regulatory focus on antimicrobial stewardship has led to stricter guidelines, influencing prescribing behaviors. Additionally, licensing for novel formulations or combination therapies may open new revenue streams.

Pricing and Reimbursement Policies

Pricing strategies for ertapenem vary notably across regions. In developed markets, reimbursement frameworks—such as Medicare in the U.S. or the National Health Service (NHS) in the UK—dictate drug pricing and influence market penetration. Post-patent expiry, generics are expected to enter at reduced price points, potentially increasing affordability but reducing margins.

Supply Chain and Manufacturing Factors

Manufacturing quality, supply chain stability, and raw material availability, especially for beta-lactam antibiotics, remain critical. Any disruptions, as seen during global supply chain crises, can distort market availability and influence prices.

Financial Trajectory

Revenue Projections

Estimates suggest that global sales of ertapenem could reach USD 1.2–1.5 billion annually within the next three to five years, with year-on-year growth driven by increasing indications, geographic expansion, and market penetration. The imminent patent expiry of brand formulations may cause a deceleration in revenue growth initially, but sustained demand for broad-spectrum antibiotics ensures long-term stability.

Profitability and Cost Considerations

Profit margins are expected to compress post-patent expiry due to intensified generic competition. R&D investments into novel carbapenem formulations or combination therapies may serve as future revenue catalysts but entail substantial upfront costs. Additionally, manufacturers invest heavily in compliance with evolving regulatory standards, influencing the overall financial outlook.

Impact of Generic Competition

The entry of generic manufacturers typically leads to a price erosion of 50-70%. This transition could diminish profits for existing branded formulations but also expands market accessibility, potentially increasing volume sales.

Market Challenges and Opportunities

• Antimicrobial Stewardship: Increasing regulation and stewardship initiatives aim to curb overuse, potentially constraining market volume.
• Resistance Trends: Rising resistance to carbapenems may restrict indications or necessitate combination therapies, affecting revenue streams.
• Innovation and New Formulations: Developing longer-acting or more potent formulations could command premium pricing.
• Emerging Markets: Expansion into Asia-Pacific and Latin America offers significant revenue potential due to increasing infection prevalence and unmet needs.

Market Risks and Mitigation Strategies

• Pricing Pressures: Companies must navigate declining prices due to generics while maintaining profitability through operational efficiencies or diversification.
• Resistance Development: Ongoing surveillance and stewardship are essential to preserve ertapenem's efficacy and market relevance.
• Regulatory Uncertainty: Proactive engagement with regulators can facilitate timely approvals for new uses or formulations.

Conclusion

Ertapenem sodium's market trajectory is shaped by a delicate nexus of clinical demand, regulatory environments, competitive pressures, and economic factors. Despite impending patent expiration and increasing generic competition, sustained growth is feasible through strategic market expansion, innovation, and robust antimicrobial stewardship. The drug's critical role in fighting resistant infections ensures continued relevance, but companies must adapt to evolving healthcare policies and resistance landscapes to optimize profitability.

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Key Takeaways

• The global ertapenem market is projected to grow at 4-6% annually, driven by rising bacterial infections and resistance.
• Patent expiry of brand formulations imminent, leading to influx of generics and significant price reductions.
• Market expansion into emerging regions offers opportunities but requires navigating regional regulatory and reimbursement complexities.
• Resistance development and antimicrobial stewardship influence market demand, necessitating ongoing innovation.
• Strategic diversification and investments in novel formulations or combination therapies can offset revenue declines and sustain profitability.

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FAQs

1. What factors are driving the future demand for ertapenem sodium?
   Rising bacterial infection rates, increasing antibiotic resistance, and growing adoption of targeted antimicrobial therapies under stewardship programs are primary drivers.

2. How will patent expiration impact the ertapenem market?
   It will catalyze the entry of generics, dramatically reducing prices, compressing margins, but potentially expanding volume sales and market access.

3. What challenges do manufacturers face with ertapenem?
   Key challenges include antibiotic resistance limiting efficacy, regulatory tightening, pricing pressures, and supply chain disruptions.

4. Are there opportunities for innovation within the ertapenem segment?
   Yes; developing longer-acting formulations, combination therapies, or new indications can generate premium revenue streams and extend product lifecycle.

5. How can companies leverage emerging markets for ertapenem?
   By tailoring regulatory strategies, forming local partnerships, and investing in awareness campaigns to address regional infectious disease burdens, companies can expand their footprint.

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References

[1] MarketWatch. (2022). Antibiotics Market Size, Trends, and Forecasts.