Cilastatin sodium; imipenem - Generic Drug Details

What are the generic sources for cilastatin sodium; imipenem and what is the scope of patent protection?

Cilastatin sodium; imipenem is the generic ingredient in three branded drugs marketed by Merck, Acs Dobfar, Hospira Inc, Hq Spclt Pharma, and Msd Merck Co, and is included in eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for cilastatin sodium; imipenem

US Patents:	1
Tradenames:	3
Applicants:	5
NDAs:	8
Finished Product Suppliers / Packagers:	3
Clinical Trials:	2
DailyMed Link:	cilastatin sodium; imipenem at DailyMed

Recent Clinical Trials for cilastatin sodium; imipenem

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
Merck Sharp & Dohme Corp.	Phase 3

See all cilastatin sodium; imipenem clinical trials

Pharmacology for cilastatin sodium; imipenem

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

US Patents and Regulatory Information for cilastatin sodium; imipenem

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acs Dobfar	IMIPENEM AND CILASTATIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	090577-002	Dec 21, 2011	AP	RX	No	No
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		RX	Yes	Yes			Y	Y
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

Expired US Patents for cilastatin sodium; imipenem

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;INTRAVENOUS	050587-002	Nov 26, 1985
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAMUSCULAR	050630-002	Dec 14, 1990
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	050587-001	Nov 26, 1985

Cilastatin sodium; imipenem Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Imipenem/Cilastatin Sodium

Introduction to Imipenem/Cilastatin Sodium

Imipenem/Cilastatin Sodium is a combination drug consisting of two individual components: Imipenem, a broad-spectrum beta-lactam antibiotic of the carbapenem class, and Cilastatin Sodium, which inhibits the renal enzyme dehydropeptidase-I, thereby preventing the degradation of Imipenem in the kidneys. This combination is marketed under the brand name Primaxin by Merck & Co.[4].

Market Overview

The global Imipenem/Cilastatin market has been experiencing significant growth driven by several key factors:

• Technological Advancements: Continuous improvements in manufacturing processes and the development of new formulations have enhanced the efficacy and stability of the drug[1][4].
• Increasing Demand: The rising incidence of bacterial infections, particularly those resistant to other antibiotics, has increased the demand for broad-spectrum antibiotics like Imipenem/Cilastatin[4].
• Expanding Applications: The drug's multiple indications, including hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP), contribute to its market growth[3].

Market Size and Forecast

As of the recent analysis, the global Imipenem/Cilastatin market size was valued at approximately $5.446 billion in 2017, with a Compound Annual Growth Rate (CAGR) of 17% from 2014 to 2017. It is forecasted to grow at a CAGR of 23% from 2018 to 2023[4].

Market Segmentation

By Type

The market is segmented based on the types of Imipenem/Cilastatin products, each with unique characteristics and applications:

• Type 1: Focuses on the most commonly used products, known for their efficiency and reliability, holding a market share of around 40%[1].
• Type 2: Characterized by its application in advanced technologies, gaining traction due to innovative features, with a market share of about 35%[1].
• Type 3: Utilized in specialized industries, focusing on performance and customization options, with a market share of approximately 25%[1].

By Application

The market is also segmented by application, with various sectors driving demand:

• Hospital-Acquired Bacterial Pneumonia (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP): These are significant applications, as evidenced by the success of Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) in Phase 3 trials[3].
• Surgical Infections: Imipenem/Cilastatin is effective in treating serious surgical infections, often as a single-agent therapy[5].

By Geography

The market is spread across various regions, each contributing differently to the overall growth:

• Brazil: The Southeast region of Brazil is a major hub for technological advancements and industrial growth, holding a significant market share of 50%[1].
• Global: Other key regions include North America, Europe, Asia, South America, Africa, and Oceania, each with their own market dynamics and growth factors[4].

Competitive Landscape

The competitive landscape of the Imipenem/Cilastatin market is characterized by:

• Key Players: Merck & Co. is a major player, with its brand Primaxin being a market leader. Other companies also participate in the global market, contributing to the competitive environment[1][4].
• Innovations: Continuous innovation in drug formulations and delivery systems is a key factor in maintaining competitiveness[1].

Financial Impact and Cost Savings

Adjusting dosages of Imipenem/Cilastatin based on patient-specific factors such as creatinine clearance and body weight can result in significant cost savings. A study at a university-affiliated hospital found that appropriate dosing adjustments could lead to an annual cost savings of $11,500[2].

Regulatory Environment

The regulatory environment plays a crucial role in shaping the market. Regulatory approvals and guidelines influence the manufacturing, distribution, and use of Imipenem/Cilastatin. For instance, the success of Merck’s RECARBRIO™ in Phase 3 trials was a significant regulatory milestone[3].

Supply Chain Analysis

The supply chain for Imipenem/Cilastatin involves complex interactions between manufacturers, distributors, and healthcare providers. Factors such as manufacturing difficulties, market conditions, and financial instability can impact the supply chain and, consequently, the market dynamics[1][3].

Technological Developments

Technological advancements are a driving force behind the growth of the Imipenem/Cilastatin market. Improvements in manufacturing processes, drug delivery systems, and the development of combination therapies like RECARBRIO™ (imipenem, cilastatin, and relebactam) are key examples[1][3].

Challenges and Opportunities

Challenges

• Intense Competition: The market faces intense competition from other antibiotic classes and generic versions of Imipenem/Cilastatin[1].
• Rapidly Evolving Technology: The need to keep pace with technological advancements and changing market demands is a significant challenge[1].
• Regulatory Hurdles: Navigating the complex regulatory landscape can be challenging for manufacturers[3].

Opportunities

• Growing Demand: The increasing incidence of bacterial infections and the need for effective antibiotics present a significant opportunity for growth[4].
• Emerging Markets: Expanding into new geographical regions, particularly in developing countries, offers potential for market expansion[4].

Key Takeaways

• The Imipenem/Cilastatin market is driven by technological advancements, rising demand, and multiple applications.
• The market is segmented by type, application, and geography, with significant growth potential in regions like Brazil.
• Adjusting dosages based on patient-specific factors can lead to significant cost savings.
• The competitive landscape is characterized by innovation and the presence of key players like Merck & Co.
• Regulatory and supply chain factors play critical roles in shaping the market.

FAQs

1. What is the current market size of the Imipenem/Cilastatin Sodium market?

The global Imipenem/Cilastatin market size was valued at approximately $5.446 billion in 2017 and is forecasted to grow further[4].

2. What are the primary applications of Imipenem/Cilastatin Sodium?

Primary applications include hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), and surgical infections[3][5].

3. Which regions are significant in the Imipenem/Cilastatin market?

Key regions include Brazil, North America, Europe, Asia, South America, Africa, and Oceania, each contributing differently to the market growth[1][4].

4. How can adjusting dosages of Imipenem/Cilastatin impact costs?

Adjusting dosages based on patient-specific factors like creatinine clearance and body weight can result in significant cost savings, such as an annual cost savings of $11,500 in a hospital setting[2].

5. What are the major challenges faced by the Imipenem/Cilastatin market?

Major challenges include intense competition, rapidly evolving technology, and the need to adapt to changing market demands and regulatory hurdles[1][3].

Sources

1. Brazil Imipenem Cilastatin Sodium API Market By Type, By Application, Size And Scope. Absolute.
2. Evaluation and financial impact of imipenem/cilastatin dosing in elderly patients. PubMed.
3. Pivotal RESTORE-IMI 2 Phase 3 Study of Merck's RECARBRIO™ (imipenem, cilastatin, and relebactam) in Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) Met Primary Endpoint. Merck.
4. Global Imipenem/Cilastatin Market Insights, Size and Growth. Sper Research.
5. Prospective Study Comparing Imipenem—cilastatin sodium with that of the combination of clindamycin and gentamicin in surgical infections. JAMA Network.