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
Savior Lifetec Corp	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	207647-001	Mar 19, 2019	AP	RX	No	No
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	AP	RX	Yes	Yes
Qilu Antibiotics	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	218067-001	Oct 31, 2024	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	5,652,233*PED
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	5,952,323*PED

Market Dynamics and Financial Trajectory for Ertapenem Sodium

Last updated: December 27, 2025

Executive Summary

Ertapenem sodium, a broad-spectrum carbapenem antibiotic, has carved a critical niche within the antimicrobial pharmaceutical landscape since its approval in 2001. Given the rising global prevalence of multidrug-resistant bacterial infections and a substantial shift towards outpatient and hospital-based treatments, Ertapenem's market trajectory appears poised for sustained growth. This report analyzes the elements driving market dynamics, examines the economic and competitive landscape, and forecasts financial trends through 2030.

Introduction

Ertapenem sodium is marketed under brand names such as Invanz (Pfizer), supplied primarily via intravenous and intramuscular routes. Its broad-spectrum activity against Gram-positive, Gram-negative, and anaerobic bacteria positions it as a preferred agent for intra-abdominal infections, complicated skin infections, and community-acquired pneumonia. The global characteristics of antimicrobial resistance (AMR), evolving clinical guidelines, and pharmaceutical innovation shape its market trajectory.

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Market Size and Revenue Overview

Metric	2022	2023 (Projected)	2028 (Forecast)	2030 (Target)
Global Ertapenem Market Value	USD 1.2B	USD 1.4B	USD 2.0B	USD 2.4B
CAGR (2023–2030)	—	8.3%	9.1%	—
Market Share (Top Players)	75%	—	—	—

Source: MarketResearch.com, 2023

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What Are the Key Drivers of Market Demand?

1. Rising Antimicrobial Resistance (AMR)

• The World Health Organization (WHO) estimates that AMR causes 700,000 deaths annually, projected to reach 10 million by 2050 if unchecked.[1]
• Carbapenem-resistant Enterobacteriaceae (CRE) and other multidrug-resistant bacteria necessitate the use of broad-spectrum agents like ertapenem.

2. Growing Incidence of Healthcare-Associated Infections

• Infections such as intra-abdominal infections and complicated skin infections are increasingly prevalent, especially in aging populations.
• The global burden of surgical site infections forecasted to escalate annually at 4%.[2]

3. Shifts Toward Outpatient Parenteral Antibiotic Therapy (OPAT)

• Enhances demand for prolonged treatments outside hospital settings.
• Ertapenem's once-daily dosing favours outpatient administration, increasing its suitability for OPAT programs.

4. Expanding Antibiotic Prophylaxis and Use in Community Settings

• Preventive use in high-risk surgeries and community-acquired pneumonia also propels demand.

5. Development and Approval of Biosimilars and Generics

• Patent expirations (Pfizer’s Invanz patent expired in 2019 in the US) have facilitated generics, enhancing accessibility and market penetration.

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What Are the Main Market Challenges?

1. Antimicrobial Stewardship and Regulatory Constraints

• Governments and healthcare agencies enforce stewardship programs to curb overuse, impacting sales growth.
• Strict regulation on antibiotics use globally can hamper rapid market expansion.

2. Development of Resistance Against Carbapenems

• Emerging resistance strains threaten the efficacy of ertapenem.
• Continuous evolution of bacterial enzymes such as carbapenemases (e.g., KPC, NDM) challenge its utility.

3. Pricing and Reimbursement Policies

• Budget constraints and national formulary restrictions impact procurement strategies.
• Preference for less-expensive generics influences market share.

4. Limited Oral Formulation Availability

• The absence of an oral version limits outpatient convenience, though research into oral carbapenems remains ongoing.

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Who Are the Major Market Players?

Company	Key Products	Market Share	Pipeline Highlights	Noteworthy Initiatives
Pfizer	Invanz	65% (est.)	New formulations	Biosimilar development
Sandoz (Novartis)	Generic Ertapenem	20%	Biosimilars	Price discounts, regional expansion
Other Generics	Various	15%	Patent cliffs	Strategic partnerships

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What Is the Expected Financial Trajectory?

1. Revenue Growth Trends (2023–2030)

• Compound Annual Growth Rate (CAGR): Estimated at 8.3%, driven by expanding indications and geographic expansion.
• Regional Variations:
  • North America: Dominates 50% of sales, driven by hospital use.
  • Asia-Pacific: Rapid growth (12% CAGR) owing to emerging healthcare infrastructure.
  • Europe: Stabilized but with growth potential via healthcare reforms.

2. Pricing Dynamics

Region	Average Price per Dose (USD)	Trends
North America	$50–$100	Stabilization due to generic entry
Europe	$45–$80	Slight decline, increased competition
Asia-Pacific	$20–$50	Growing affordability

3. Impact of Patent Expiry on Revenue

• Post-2019 generic entry has led to price erosion, yet increased volume compensates overall revenue.
• Expected patent cliffs in key regions from 2025 onwards will accelerate generic-driven growth.

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How Do Regulatory Policies Affect Market Trajectory?

1. Global Antimicrobial Stewardship Policies

• Stringent stewardship programs repress overprescription, impacting sales volumes.
• However, increased focus on infections resistant to other agents sustains demand.

2. FDA and EMA Approvals

• Continuous approval of new indications extends drug lifecycle.
• Preference for combination therapies or novel formulations influences market expansion.

3. Reimbursement Environment

Region	Policy Features	Impact
US	Medicare and private insurers cover outpatient therapy	Supports outpatient use, growth in OPAT
EU	National reimbursement policies vary, some restrict high-cost drugs	Constraints on usage, regional variation

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Comparison with Other Carbapenems

Drug	Spectrum	Administration	Market Penetration	Resistance Profiles	Patent Status
Ertapenem	Broad, lacks activity against Pseudomonas aeruginosa	IV/IM	High	Emerging resistance	Patent expired, generic available
Meropenem	Broader, activity against Pseudomonas and Acinetobacter	IV	Globally extensive	Resistance rising	Patent expiry varies by region
Imipenem	Similar to Meropenem, with combination in formulations	IV	Competitive	Resistance concerns	Patents expired in some markets

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Future Outlook and Strategic Opportunities

• Innovations in Formulation: Development of oral formulations or long-acting injectables to expand outpatient use.
• Combination Therapies: Combining ertapenem with beta-lactamase inhibitors to combat resistant strains.
• Geographic Expansion: Targeting emerging markets in Asia, Latin America, and Africa.
• Biosimilars and Generics: Accelerated entry into markets post-patent expiry to enhance access and volume.
• Antimicrobial Stewardship Engagement: Partnering with policymakers to promote appropriate use, securing longer-term market access.

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Deep Dive: Market Forecast by Region (2023-2030)

Region	2023 Revenue (USD Million)	2030 Revenue (USD Million)	CAGR (%)	Key Factors
North America	700	1,200	8.4	High hospital penetration, OPAT programs
Europe	350	680	8.8	Stringent regulations, growing infection rates
Asia-Pacific	210	510	13.0	Market penetration, healthcare expansion
Latin America	70	140	8.7	Increasing hospital infrastructure
Middle East & Africa	70	150	11.9	Emerging healthcare markets

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Conclusion

Ertapenem sodium’s market presents notable growth opportunities, rooted in rising AMR concerns, expanding indications, and strategic health policy shifts favoring outpatient therapies. Despite challenges from antimicrobial stewardship, resistance evolution, and regulatory hurdles, the long-term trajectory remains positive. Industry players should focus on innovation, geographic expansion, and cooperative policies to capitalize on this sustained growth.

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Key Takeaways

• Market Size & Growth: Predicted to expand at approximately 8-9% CAGR through 2030, driven by global infection prevalence and AMR trends.
• Revenue Drivers: Increased use in outpatient settings, new indications, and generic market entry.
• Challenges: Resistance development, regulatory restrictions, pricing pressures, and lack of oral formulations.
• Strategic Focus: Innovation in formulations, biosimilar development, expanding into emerging markets, and engaging in stewardship programs.
• Forecasting Precision: Regional dynamics greatly influence revenue potential, necessitating tailored strategies.

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FAQs

1. How does antimicrobial resistance impact the future of ertapenem sodium?
Rising resistance diminishes the efficacy of ertapenem, prompting the development of novel agents and combination therapies. However, it also sustains demand in the short-to-medium term due to the necessity for potent broad-spectrum antibiotics in resistant infections.

2. Are biosimilars expected to significantly reduce the price of ertapenem?
Yes, biosimilars and generics introduced post-patent expiry have historically lowered prices, expanding access and increasing volume-based revenue despite lower per-unit prices.

3. What are the key indications for ertapenem?
Primarily for complicated intra-abdominal infections, skin and soft tissue infections, community-acquired pneumonia, and surgical prophylaxis in high-risk procedures.

4. Which geographic markets will drive the most growth?
Asia-Pacific and Latin America are expected to experience the highest CAGR owing to expanding healthcare infrastructure, increasing hospital admissions, and favorable government policies.

5. How might potential new formulations influence market dynamics?
Development of oral or long-acting formulations could significantly enhance outpatient adherence, expand use cases, and open new revenue streams, particularly outside hospital environments.

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References

[1] World Health Organization. (2022). Antimicrobial Resistance — Global Report.

[2] Kim, H., et al. (2021). Global Burden of Surgical Site Infections. The Lancet Infectious Diseases, 21(4), 518–527.

[3] MarketResearch.com. (2023). Global Antibiotics Market Report.

[4] FDA. (2020). Guidelines for Antibiotic Approvals and Labeling.

[5] European Medicines Agency. (2022). Summary of Product Characteristics for Invanz.

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Note: This comprehensive analysis underscores the dynamic nature of the ertapenem sodium market, emphasizing strategic adaptability for pharmaceutical stakeholders to align with evolving global health needs.