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 Avet Lifesciences, Fresenius Kabi Usa, Nexus, Pharmobedient, Sagent Pharms Inc, Xellia Pharms Aps, and Ph Health, 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:	24
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
University Hospital Fattouma Bourguiba	PHASE2
Beni-Suef University	PHASE4
Ain Shams University	PHASE2

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
Ph Health	COLY-MYCIN M	colistimethate sodium	INJECTABLE;INJECTION	050108-002	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Pharmobedient	COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	064216-001	Feb 26, 1999		DISCN	No	No
Nexus	COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	065177-001	Mar 19, 2004		DISCN	No	No
Avet Lifesciences	COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	202359-001	Sep 28, 2012	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/001225Colobreathe 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

Market Dynamics and Financial Trajectory for Colistimethate Sodium

Last updated: February 12, 2026

Market Position and Indications

Colistimethate sodium is a polymyxin antibiotic primarily used as a last-line treatment for multi-drug resistant Gram-negative bacterial infections, including Pseudomonas aeruginosa, Acinetobacter baumannii, and Klebsiella pneumoniae. Its primary use is in hospital settings, particularly for pneumonia, bloodstream infections, and meningitis caused by resistant pathogens.

Market Size and Growth Drivers

• The global antibiotics market was valued at approximately $50 billion in 2022, with antibiotics targeting resistant bacteria accounting for roughly 15%.
• The segment specifically for colistimethate sodium is estimated at $300 million in 2022, due to its reserved use and limited production.
• The market is projected to grow at a CAGR of 4% to 6% through 2030, driven by rising antimicrobial resistance (AMR) and dwindling efficacy of alternative antibiotics.

Key Market Players and Supply Dynamics

• Major manufacturers include Statens Serum Institut (Denmark), Sigmapharm Laboratories (USA), and Seekamp Healthcare (India).
• The drug is produced via complex fermentation processes, leading to limited manufacturing capacity. Supply constraints are common during surges in demand.
• Market entry barriers are high due to regulatory requirements and manufacturing complexity, resulting in limited competition.

Regulatory Landscape

• The U.S. Food and Drug Administration (FDA) approved colistimethate sodium as an orphan drug for specific indications.
• European Medicines Agency (EMA) approval aligns with FDA standards; however, off-label use remains widespread due to lack of approved alternatives.
• The drug faces regulatory scrutiny over nephrotoxicity and neurotoxicity, impacting prescribing patterns and market acceptance.

Pricing Trends and Reimbursement

• Price per vial varies by region, with the U.S. market averaging around $70 to $100 per 300 mg dose in 2022.
• High treatment costs, combined with hospitalization expenses, limit access in low-income settings.
• Reimbursement policies are limited, often dependent on hospital budgets and insurance coverage, constraining market expansion.

Technological and Clinical Development

• No new formulations or delivery methods are currently in advanced development stages.
• Some research focuses on combination therapies to reduce toxicity and improve efficacy.
• The emergence of novel antibiotics targeting resistant bacteria diminishes reliance on colistimethate sodium, risking future market contraction.

Financial Outlook

Year	Market Revenue (USD millions)	Growth Rate	Key Factors
2022	300	N/A	Limited supply, resistant infections
2023	312	4%	Increasing AMR cases
2025	345	7%	Growing hospital use, limited competition
2030	375	3-6%	Market saturation, emergence of alternatives

Challenges and Opportunities

• Challenges:
  • Toxicity concerns lead to cautious prescribing.
  • Supply limitations hinder scaling during outbreaks.
  • Regulatory concerns around stewardship and safety lead to tighter controls.
• Opportunities:
  • Developing safer formulations.
  • Expanding indications for off-label use.
  • Increasing use in combination therapies.

Conclusion

The market for colistimethate sodium remains constrained by toxicity issues, supply bottlenecks, and limited innovation. Growth will depend largely on the ongoing threat of antimicrobial resistance and hospital demand, with the potential for expansion through clinical research and formulation improvements.

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Key Takeaways

• Colistimethate sodium is a critical antibiotic for resistant infections but faces supply and safety challenges.
• Market growth is modest, driven by rising AMR and hospital usage.
• Price and reimbursement variability influence accessibility, especially in lower-income regions.
• No significant new product innovations are in advanced development, risking future market decline.
• Focused strategies on safety profile improvements and combinatorial therapies can influence market trajectory.

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FAQs

1. What factors limit the global adoption of colistimethate sodium?
Safety concerns, supply limitations, and high treatment costs restrict widespread adoption, particularly outside hospital settings.

2. How does antimicrobial resistance influence the market for colistimethate sodium?
Rising resistance increases demand for last-line therapies like colistimethate sodium, but also prompts development of newer antibiotics, potentially reducing reliance.

3. Are there any ongoing efforts to develop safer formulations?
Research is ongoing into alternative delivery methods and combination therapies to mitigate toxicity, but none are near market approval.

4. What regions represent the largest markets for colistimethate sodium?
North America and Europe have the highest per-capita utilization due to better hospital infrastructure; Asia-Pacific shows growth owing to rising AMR rates.

5. How does regulatory scrutiny impact the future of colistimethate sodium?
Regulatory oversight over toxicity and stewardship may restrict off-label uses and influence prescribing patterns, potentially impacting market size.

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Citations

[1] MarketsandMarkets, "Antibiotics Market," 2022.
[2] IQVIA, "Global Antibiotics Market Data," 2022.
[3] U.S. FDA, "Drug Approvals and Safety Communications," 2022.
[4] European Medicines Agency (EMA), "Medicines for Resistant Gram-negative Infections," 2022.