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. Four 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:	4
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
Xellia Pharms Aps	COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	205356-001	May 29, 2015	AP	RX	No	No
Fresenius Kabi Usa	COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	065364-001	Apr 17, 2008	AP	RX	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 the Pharmaceutical Drug: Colistimethate Sodium

Last updated: July 27, 2025

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Introduction

Colistimethate sodium, a critical antibiotic within the polymyxin class, plays an essential role in combating multidrug-resistant (MDR) Gram-negative bacterial infections. Its unique mechanism of action targets pathogens resistant to most other antibiotics, positioning it as a last-resort therapeutic agent. The evolving landscape of antimicrobial resistance (AMR), coupled with regulatory, clinical, and economic factors, significantly influences the market dynamics and financial trajectory of colistimethate sodium.

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Market Overview and Demand Drivers

The global antibiotic market experiences consistent growth, projected to reach approximately USD 52 billion by 2028, with critical antibiotics like colistimethate sodium constituting an indispensable niche segment. The specific demand for colistimethate sodium is primarily driven by the escalation of MDR infections, particularly in healthcare-associated settings.

Rising Antimicrobial Resistance

Multidrug-resistant organisms such as Pseudomonas aeruginosa, Acinetobacter baumannii, and carbapenem-resistant Enterobacteriaceae (CRE) drive demand. According to the CDC, the prevalence of MDR pathogens has surged, leading clinicians to rely on colistimethate sodium as a therapeutic option, especially in intensive care units (ICUs) where serious infections are common. The World Health Organization (WHO) also classifies these bacteria as priority pathogens, reinforcing the critical role of colistimethate sodium.

Clinical Adoption and Off-label Use

Although initially approved for aerosolized and parenteral administration, colistimethate sodium's off-label use to treat ventilator-associated pneumonia (VAP) and bloodstream infections has contributed to increased utilization. Hospitals in regions with high MDR prevalence are adopting colistimethate sodium as part of combination therapies, further fueling demand.

Regulatory Landscape and Market Challenges

Regulatory Approvals and Intellectual Property

The regulation of colistimethate sodium varies across jurisdictions. The drug is off-patent in many regions, leading to numerous generic manufacturing entities, which enhances market competition but exerts downward pressure on prices. Recent regulatory updates, such as EMA's approval of colistimethate sodium formulations in Europe, have facilitated easier access and wider adoption.

Quality Control and Safety Concerns

Concerns over nephrotoxicity and neurotoxicity associated with colistimethate sodium influence prescribing patterns. Improved formulations and dosing guidelines have mitigated some safety issues, but these concerns remain barriers in certain markets, impacting overall market expansion.

Supply Chain and Manufacturing Factors

The production of colistimethate sodium depends on specialized fermentation processes using Paenibacillus strains. Manufacturing complexities and regulatory compliance requirements can pose supply chain challenges, especially during the COVID-19 pandemic’s strain on global pharmaceutical logistics. However, the entry of multiple generics has optimized supply and stabilized pricing.

Financial Trends and Market Competition

Pricing Dynamics

The openness to generic competition has led to significant price erosion, especially in North America and Europe. Prices for branded formulations have decreased by approximately 30-50% over the past five years, aligning with increased market competition. However, in emerging markets, pricing remains relatively high due to lower generic penetration and regulatory hurdles.

Market Share and Player Landscape

Key players include Sandoz (a Novartis division), Teva Pharmaceuticals, and multiple regional manufacturers. Sandoz, with its established distribution network and regulatory expertise, captures a significant market share in developed regions. Conversely, regional manufacturers dominate emerging markets, where affordability is critical.

Investment and R&D

Limited pipeline development exists for new polymyxin derivatives or alternative agents targeting MDR Gram-negative bacteria, cementing colistimethate sodium’s status as a cornerstone therapy. Consequently, manufacturers continue to invest minimally in R&D specific to colistimethate sodium, focusing instead on novel antibiotics under development that might replace it in future treatment paradigms.

Future Market Projections

Growth Outlook

The market for colistimethate sodium is anticipated to grow at a CAGR of approximately 4-6% through 2028, driven chiefly by the global burden of MDR infections. Countries like India, China, and Brazil are expected to exhibit rapid growth owing to escalating antimicrobial resistance rates and expanding healthcare infrastructure.

Emerging Trends

• Increased Regulatory Approvals: Approvals for pre-filled, ready-to-use formulations are expected to facilitate dosing precision, safety, and ease of administration, potentially expanding markets.
• Enhanced Safety Profiles: Ongoing optimization of formulations may mitigate toxicity concerns, broadening clinical acceptance.
• Development of Diagnostic Tools: Companion diagnostics that identify MDR infections accurately will influence prescribing practices, potentially increasing demand for colistimethate sodium.

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Market Barriers and Risks

• Toxicity and Safety Issues: Ongoing safety concerns may limit broader adoption, especially outside critical care settings.
• Antibiotic Stewardship Initiatives: Stricter antimicrobial stewardship programs may restrict use, impacting sales volume.
• Emerging Resistance: The potential development of resistance to colistimethate sodium itself poses long-term risks, potentially necessitating alternative therapies.
• Pricing and Reimbursement: Regulatory and reimbursement policies, especially in cost-sensitive markets, may restrict market expansion.

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Strategic Opportunities

• Formulation Innovation: Development of less toxic, inhalable, or combination formulations could open new therapeutic avenues.
• Global Access Initiatives: Collaborations with global health organizations can facilitate broader access in low- and middle-income countries (LMICs), expanding the market.
• Partnerships and Licensing: Strategic partnerships with regional manufacturers can enhance distribution and reduce production costs.

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Conclusion

Colistimethate sodium remains a vital component in the fight against MDR Gram-negative infections, with a market driven by rising resistance trends and limited alternatives. While price pressures and safety concerns temper growth, ongoing regulatory approvals, formulation advancements, and the critical nature of its clinical role underpin a positive long-term financial trajectory. Stakeholders must navigate evolving regulatory landscapes, safety profiles, and antimicrobial stewardship policies to optimize market position and leverage growth opportunities.

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Key Takeaways

• The demand for colistimethate sodium is fundamentally driven by the escalating threat of MDR bacteria, especially in hospital settings.
• Market competition from generics leads to declining prices, but demand persists due to limited alternative treatment options.
• Safety concerns influence prescribing behaviors but are mitigated through improved formulations and clinical guidelines.
• Growth prospects remain favorable, particularly in emerging markets, with potential for formulation innovations and global access initiatives.
• Strategic investments in safety, formulations, and partnerships can enhance market position and revenue streams.

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FAQs

1. What are the main therapeutic indications for colistimethate sodium?
Primarily used for severe, multidrug-resistant Gram-negative bacterial infections such as pneumonia, septicemia, and complicated urinary tract infections, especially when other antibiotics fail.

2. How does antimicrobial resistance impact the global market for colistimethate sodium?
Rising MDR prevalence directly increases demand, positioning colistimethate sodium as a critical last-line therapy, thereby sustaining and expanding its market.

3. What are the key challenges facing the market for colistimethate sodium?
Safety concerns related to nephrotoxicity, regulatory hurdles, the emergence of resistance to colistimethate sodium itself, and pricing pressures from generic competition.

4. Are there ongoing developments that could influence the future of colistimethate sodium?
Yes, innovations in formulations to reduce toxicity, regulatory approvals of new formulations, and the development of rapid diagnostics could significantly influence its market trajectory.

5. How do global antimicrobial stewardship policies affect the sales of colistimethate sodium?
Stewardship programs promoting judicious antibiotic use may restrict its use to severe, confirmed MDR cases, potentially limiting overuse but maintaining demand for critical infections.

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References

1. Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States, 2019.
2. World Health Organization. Priority Pathogens for Research & Development of New Antibiotics, 2017.
3. Market Research Future. Global Antibiotics Market Size, Share & Trends Analysis Report, 2021.
4. Sandoz. Product Portfolio – Colistimethate Sodium.
5. European Medicines Agency. Summary of Product Characteristics for Colistimethate.