COLISTIMETHATE SODIUM - Generic Drug Details

What are the generic sources for colistimethate sodium and what is the scope of freedom to operate?

Colistimethate sodium is the generic ingredient in two branded drugs marketed by Adrastea Pharma, Avet Lifesciences, Fresenius Kabi Usa, Nexus, Sagent Pharms Inc, Xellia Pharms Aps, and Endo Operations, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for colistimethate sodium. Five suppliers are listed for this compound.

Summary for COLISTIMETHATE SODIUM

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	20
Drug Prices:	Drug price trends for COLISTIMETHATE SODIUM
What excipients (inactive ingredients) are in COLISTIMETHATE SODIUM?	COLISTIMETHATE SODIUM excipients list
DailyMed Link:	COLISTIMETHATE SODIUM at DailyMed

See drug prices for COLISTIMETHATE SODIUM

Recent Clinical Trials for COLISTIMETHATE SODIUM

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

Sponsor	Phase
Southeast University, China	N/A
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Phase 3
Zambon SpA	Phase 3

See all COLISTIMETHATE SODIUM clinical trials

Pharmacology for COLISTIMETHATE SODIUM

Drug Class

Polymyxin-class Antibacterial

US Patents and Regulatory Information for COLISTIMETHATE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nexus	COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	065177-001	Mar 19, 2004	AP	RX	No	No
Sagent Pharms Inc	COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	201365-001	Feb 19, 2014	AP	RX	No	No
Adrastea Pharma	COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	064216-001	Feb 26, 1999	AP	RX	No	No
Endo Operations	COLY-MYCIN M	colistimethate sodium	INJECTABLE;INJECTION	050108-002	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Fresenius Kabi Usa	COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	065364-001	Apr 17, 2008	AP	RX	No	No
Xellia Pharms Aps	COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	205356-001	May 29, 2015	AP	RX	No	No

EU/EMA Drug Approvals for COLISTIMETHATE SODIUM

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva B.V.	Colobreathe	colistimethate sodium	EMEA/H/C/001225 Colobreathe is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged six years and older.Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	no	2012-02-13

COLISTIMETHATE SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Colistimethate Sodium

Introduction

Colistimethate sodium, a derivative of the antibiotic colistin, is a critical drug in the treatment of infections caused by multidrug-resistant Gram-negative bacteria. Here, we delve into the market dynamics and financial trajectory of this essential antibiotic.

Global Market Size and Forecast

The global market for colistin, which includes colistimethate sodium, was valued at US$ 58 million in 2023. However, the market is expected to decline slightly to US$ 54 million by 2030, with a Compound Annual Growth Rate (CAGR) of -1.4% during the forecast period of 2024-2030[1].

Key Players

The market for colistimethate sodium is dominated by several key players, including Shengxue Dacheng, Apeloa, Livzon Group, LKPC, Xellia, Shenghua Biok, Qianjiang Biochemical, and Lifecome. These companies play a significant role in the production, distribution, and innovation within the colistin market[1].

Applications and Types

Colistimethate sodium is used in various applications, primarily in the treatment of infections in pigs and chickens. The drug is available in different forms, including Active Pharmaceutical Ingredient (API), premix, and other formulations. These diverse applications and forms contribute to its market presence[1].

Global Trade and Manufacturing

China is the major manufacturer of colistin, including both pharmaceutical raw material (PRM) and feed additives. Between 2018 and 2021, China exported significant quantities of PRM and feed additives to various countries, highlighting the global reach of colistimethate sodium production and trade[4].

Usage in Animal Husbandry

Colistin, including its derivative colistimethate sodium, is widely used in animal husbandry, particularly in poultry and pig farming, for treatment, metaphylaxis, prophylaxis, and as a growth promoter. However, this widespread use has raised concerns about antimicrobial resistance. In countries like Pakistan, the intensive livestock farming sector is a significant consumer of colistin[4].

Regulatory and Safety Concerns

The use of colistimethate sodium is not without regulatory and safety concerns. Health Canada has identified a link between the use of colistin (colistimethate sodium) and the risk of pseudo-Bartter syndrome, a condition characterized by metabolic alkalosis, hypokalemia, and other electrolyte abnormalities. This has led to updates in the product safety information and warnings in the Canadian product monograph[5].

Clinical Use and Efficacy

Colistimethate sodium is a last-resort antibiotic for treating infections caused by carbapenem-resistant Gram-negative bacteria. It has been used effectively in clinical settings, particularly in hospitals, for treating acute or chronic infections such as pneumonia, bloodstream infections, and meningitis. However, its use is often limited due to its potential side effects and the risk of developing resistance[3][5].

Economic Impact

The economic impact of colistimethate sodium is multifaceted. While the drug itself is relatively expensive, its use can significantly reduce healthcare costs by treating severe infections that would otherwise be difficult or impossible to manage. The market decline forecasted between 2024 and 2030 may be influenced by regulatory pressures, increasing resistance, and the development of alternative antibiotics[1].

Market Trends and Challenges

Several trends and challenges shape the market for colistimethate sodium:

• Antimicrobial Resistance: The increasing resistance to colistin is a significant challenge, necessitating stricter regulations on its use in animal husbandry and human medicine.
• Regulatory Environment: International and national regulations aimed at curbing antimicrobial resistance are likely to impact the market. For instance, China's ban on the use of colistin as a growth promoter has affected its production and export[4].
• Innovation and Alternatives: The development of new antibiotics and alternative treatments could reduce the reliance on colistimethate sodium, influencing market dynamics.

Future Outlook

The future outlook for colistimethate sodium is complex. While it remains a crucial drug in the fight against multidrug-resistant infections, its market is expected to decline due to various factors. Strict regulations, increasing resistance, and the development of new treatments will continue to shape the market trajectory.

Key Takeaways

• The global colistin market, including colistimethate sodium, is forecasted to decline to US$ 54 million by 2030.
• Key players include Shengxue Dacheng, Apeloa, and others.
• The drug is widely used in animal husbandry and human medicine.
• Regulatory concerns and antimicrobial resistance are significant challenges.
• Health Canada has identified a link between colistimethate sodium and pseudo-Bartter syndrome.

Frequently Asked Questions (FAQs)

Q: What is the current market size of colistin, including colistimethate sodium? A: The global market for colistin was valued at US$ 58 million in 2023[1].

Q: Who are the main players in the colistimethate sodium market? A: The main players include Shengxue Dacheng, Apeloa, Livzon Group, LKPC, Xellia, Shenghua Biok, Qianjiang Biochemical, and Lifecome[1].

Q: What are the primary applications of colistimethate sodium? A: The primary applications are in the treatment of infections in pigs and chickens, as well as in human medicine for treating severe infections[1][4].

Q: What are the safety concerns associated with colistimethate sodium? A: Health Canada has identified a link between the use of colistimethate sodium and the risk of pseudo-Bartter syndrome[5].

Q: How is the global trade of colistimethate sodium regulated? A: The global trade is subject to various regulations, but there is a need for stricter laws to mitigate antimicrobial resistance, especially in low-income and middle-income countries[4].

Cited Sources:

1. Valuates Reports - Global and Japan Colistin Market Report.
2. Synapse - Colistimethate Sodium Drug Targets, Indications, Patents.
3. Oxford Academic - Treatment Options for Carbapenem-resistant Gram-negative Bacteria.
4. The Lancet - International manufacturing and trade in colistin, its implications in low-income and middle-income countries.
5. Health Canada - Summary Safety Review - Colistin (colistimethate sodium).