Ertapenem sodium - Generic Drug Details

What are the generic 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 Pharma Ltd, Qilu, 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. Fifteen 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:	15
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	12
Patent Applications:	647
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
Qilu	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	218067-001	Oct 31, 2024	AP	RX	No	No
Savior Lifetec Corp	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	207647-001	Mar 19, 2019	AP	RX	No	No
Acs Dobfar Spa	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	208790-001	Apr 16, 2018	AP	RX	No	No
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	AP	RX	Yes	Yes
Gland Pharma Ltd	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	212040-001	Mar 26, 2021	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

Ertapenem sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ertapenem Sodium

Introduction to Ertapenem Sodium

Ertapenem sodium, marketed under the brand name INVANZ, is a broad-spectrum antibiotic used to treat a variety of bacterial infections, including those caused by multidrug-resistant Gram-negative bacteria. Its unique pharmacokinetic profile and broad spectrum of activity make it a crucial component in the fight against antibiotic-resistant infections.

Market Size and Forecast

The global Ertapenem sodium market has been experiencing significant growth. As of 2023, the market size was valued at approximately USD 1.3 billion and is projected to reach USD 2.2 billion by 2031, growing at a compound annual growth rate (CAGR) of 6.6% from 2024 to 2031[1][3].

Key Drivers of the Market

Several factors are driving the growth of the Ertapenem sodium market:

Increasing Prevalence of Antibiotic Resistance

The rising prevalence of antibiotic-resistant infections is a major global health concern. According to the World Health Organization (WHO), antibiotic resistance is a significant threat, and the demand for effective antibiotics like Ertapenem is expected to continue rising[3].

Advancements in Formulations and Delivery Systems

The development of new formulations and delivery systems, such as extended-release formulations and combination therapies, is enhancing the efficacy and patient compliance of Ertapenem. Innovations in drug delivery technologies, like injectable formulations with prolonged release, are also contributing to the market's growth[3].

Regulatory Approvals and Expanding Therapeutic Use

Recent regulatory approvals for new indications of Ertapenem have expanded its therapeutic use, further boosting its market potential. For instance, Ertapenem is approved for the prophylaxis of surgical site infections following elective colorectal surgery[5].

Market Restraints and Challenges

Despite the growth drivers, the Ertapenem sodium market faces several challenges:

High Cost of Production

The manufacturing process for Ertapenem sodium is complex and expensive, leading to high production costs and consequently high costs for end users. This can limit its affordability and accessibility, particularly in low- and middle-income countries[1].

Antibiotic Resistance

The emergence of resistant bacterial strains can reduce the effectiveness of Ertapenem and other antibiotics, potentially leading to a decline in their use and market demand[1].

Regulatory Hurdles

Stringent regulatory requirements for the approval and commercialization of antibiotics can delay product launches and increase costs. Compliance with varying regulations across different countries can also pose challenges for market entry and expansion[1].

Competition from Generic Alternatives

As patents for Ertapenem sodium expire, generic versions of the drug can enter the market, leading to increased competition and potentially lower profit margins for original manufacturers[1].

Distribution Channels

The Ertapenem sodium market is segmented by distribution channels, which include:

Hospitals

Hospitals are the largest consumers of Ertapenem sodium due to their critical need for broad-spectrum antibiotics. The antibiotic is typically administered in emergency departments, surgical units, and intensive care units[1].

Retail Pharmacies

Retail pharmacies cater to outpatient needs, where patients might require prescriptions for Ertapenem sodium after hospital discharge or for community-acquired infections[1].

Online Pharmacies

Online pharmacies also play a role, especially in regions with well-developed e-healthcare infrastructure, though their impact is less significant compared to hospitals and retail pharmacies[1].

Geographical Segmentation

The Ertapenem sodium market is geographically segmented into several key regions:

North America

North America, particularly the United States and Canada, has a strong healthcare infrastructure and high expenditure on pharmaceuticals. The rising prevalence of drug-resistant infections in this region drives the demand for advanced antibiotics like Ertapenem sodium[1].

Europe

Europe represents a significant market segment due to robust healthcare systems and ongoing research initiatives. Countries like Germany, France, and the UK are key contributors to the market growth in this region[1].

Asia-Pacific

The Asia-Pacific region is emerging rapidly, driven by increasing bacterial infections and growing awareness about antimicrobial resistance. Countries such as China and India are seeing a surge in demand due to improving healthcare access and pharmaceutical manufacturing capabilities[1].

Middle East and Africa

In the Middle East and Africa, the market is influenced by increasing healthcare spending, though it faces challenges such as varying levels of access to medication and healthcare infrastructure[1].

Latin America

Latin America is witnessing growth due to rising bacterial infection rates and improving healthcare systems, alongside government initiatives to enhance antibiotic availability[1].

Key Players

The major players in the Ertapenem sodium market include:

• Ranbaxy Laboratories Ltd.
• Lupin Ltd.
• Sun Pharmaceutical Industries Ltd.
• Wockhardt Ltd.
• Dr. Reddy’s Laboratories Ltd.
• Cipla Ltd.
• Mylan N.V.[1]
• Kopran (Parijat Enterprises)
• Canagen Pharmaceuticals Inc
• Conderco
• Taiwan Savior Lifetec Corporation
• Taiwan Grene Biotechnology
• Xiamen Amoipharm
• Chongqing Fuan Pharmaceutical[4]

Investment Opportunities and Growth Prospects

The Ertapenem sodium market presents several opportunities for investment and growth:

Expanding into Emerging Markets

Pharmaceutical companies can capitalize on the growth by exploring opportunities in emerging markets where healthcare access and infrastructure are improving. Expanding product lines and forming strategic partnerships can enhance market presence[3].

Strategic Partnerships

Collaborations between pharmaceutical companies and research institutions are essential for advancing Ertapenem research and expanding its applications. Partnerships can facilitate innovation and drive market growth[3].

Continuous Research and Development

The ongoing need for advanced antibiotics due to the increasing prevalence of resistant infections creates a favorable environment for investment. Continuous research and development efforts support the market's growth potential[3].

Conclusion

The Ertapenem sodium market is poised for significant growth driven by the rising demand for effective treatments against antibiotic-resistant infections. With ongoing innovations, regulatory approvals, and expanding therapeutic use, Ertapenem is set to play a pivotal role in addressing the global challenge of antibiotic resistance.

Key Takeaways

• The global Ertapenem sodium market is projected to reach USD 2.2 billion by 2031, growing at a CAGR of 6.6% from 2024 to 2031.
• The market is driven by the increasing prevalence of antibiotic-resistant infections and advancements in formulations and delivery systems.
• High production costs, antibiotic resistance, and regulatory hurdles are significant challenges.
• Hospitals are the largest consumers, and the market is geographically diverse with key regions including North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America.
• Key players include major pharmaceutical companies, and investment opportunities lie in expanding into emerging markets and forming strategic partnerships.

Frequently Asked Questions

1. What is Ertapenem sodium used for?

Ertapenem sodium is used to treat a range of bacterial infections, including those caused by resistant strains of bacteria. It is effective against both Gram-positive and Gram-negative bacteria[3].

2. How does Ertapenem sodium differ from other antibiotics?

Ertapenem sodium has a unique pharmacokinetic profile and a broad spectrum of activity, making it effective against infections that other antibiotics cannot treat. It also has a longer half-life, allowing for once-daily dosing[3].

3. What are the main challenges facing the Ertapenem sodium market?

The main challenges include high production costs, the emergence of antibiotic-resistant bacterial strains, stringent regulatory requirements, and competition from generic alternatives[1].

4. Which regions are key markets for Ertapenem sodium?

Key regions include North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America. Each region has unique characteristics influenced by healthcare regulations, economic stability, and the prevalence of resistant bacterial strains[1].

5. What investment opportunities exist in the Ertapenem sodium market?

Investment opportunities include expanding into emerging markets, forming strategic partnerships with research institutions, and capitalizing on the continuous need for advanced antibiotics due to the increasing prevalence of resistant infections[3].

Sources Cited

1. Verified Market Research. Ertapenem Sodium Market Size, Growth, & Forecast.
2. Oxford Academic. Treatment of infections caused by multidrug-resistant Gram-negative bacteria.
3. Market Research Intellect. Ertapenem Injection Market Size And Projection.
4. Valuates Reports. Global Ertapenem Market Research Report 2024.
5. FDA. INVANZ® (Ertapenem Sodium).