Polymyxin b sulfate - Generic Drug Details

What are the generic drug sources for polymyxin b sulfate and what is the scope of freedom to operate?

Polymyxin b sulfate is the generic ingredient in five branded drugs marketed by Glaxosmithkline, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Pharmobedient, Rising, Xellia Pharms Aps, X Gen Pharms, Paddock Llc, Allergan, Bausch And Lomb, Epic Pharma Llc, Sandoz, and Somerset Theraps Llc, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for polymyxin b sulfate. Seven suppliers are listed for this compound.

Summary for polymyxin b sulfate

US Patents:	0
Tradenames:	5
Applicants:	15
NDAs:	15
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	6
What excipients (inactive ingredients) are in polymyxin b sulfate?	polymyxin b sulfate excipients list
DailyMed Link:	polymyxin b sulfate at DailyMed

Recent Clinical Trials for polymyxin b sulfate

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

Sponsor	Phase
Madonna Magdy Fahmy	Early Phase 1
Bascom Palmer Eye Institute	N/A
University of Miami	N/A

See all polymyxin b sulfate clinical trials

Pharmacology for polymyxin b sulfate

Drug Class

Polymyxin-class Antibacterial

Medical Subject Heading (MeSH) Categories for polymyxin b sulfate

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for polymyxin b sulfate

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

J01XB	Polymyxins
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S03AA	Antiinfectives
S03A	ANTIINFECTIVES
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for polymyxin b sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	AEROSPORIN	polymyxin b sulfate	INJECTABLE;INJECTION	062036-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Paddock Llc	POLYMYXIN B SULFATE	polymyxin b sulfate	POWDER;FOR RX COMPOUNDING	062455-001	Jul 27, 1983		DISCN	No	No
Epic Pharma Llc	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	065006-001	Dec 17, 1998	AT	RX	No	No
Somerset Theraps Llc	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	211572-001	Aug 5, 2024	AT	RX	No	No
Rising	POLYMYXIN B SULFATE	polymyxin b sulfate	INJECTABLE;INJECTION	090110-001	Jun 29, 2011		DISCN	No	No
Bausch And Lomb	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	064120-001	Feb 14, 1997	AT	RX	No	No

Market Dynamics and Financial Trajectory for Polymyxin B Sulfate

Last updated: July 27, 2025

Introduction

Polymyxin B sulfate is a critical antibiotic within the polymyxins class, primarily used to treat multidrug-resistant Gram-negative bacterial infections. Its resurgence is driven by rising antimicrobial resistance (AMR), fueling renewed interest from pharmaceutical companies and healthcare providers. Understanding its market dynamics and financial trajectory involves evaluating clinical demand, manufacturing complexities, regulatory landscapes, competitive forces, and emerging global health trends.

---

Clinical and Regulatory Drivers Fueling Demand

Antimicrobial Resistance (AMR) and Therapeutic Necessity
The global escalation of multidrug-resistant pathogens—particularly carbapenem-resistant Klebsiella pneumoniae and Pseudomonas aeruginosa—positions polymyxin B sulfate as a last-line defense. According to the CDC, antibiotic resistance accounts for over 2.8 million infections annually in the U.S., with roughly 35,000 deaths, emphasizing urgent need for effective treatments. Polymyxin B’s efficacy against these resistant bacteria, especially in ICU settings, sustains steady clinical demand.

Regulatory Approvals and Market Access
While polymyxin B has historically been used as an off-label injectable form, recent regulatory efforts have focused on standardizing formulations and ensuring safety profiles. FDA approvals for generic formulations and compounding standards in the U.S., along with approvals from EMA and other agencies globally, enhance market penetration.

Emerging Indications and Combination Therapies
Research exploring polymyxin B in combination with other agents for novel indications is expanding. Such innovations could widen usage beyond traditional bloodstream and pneumonia infections, bolstering future sales prospects.

---

Manufacturing and Supply Chain Dynamics

Complexity in Production
Polymyxin B sulfate’s manufacturing involves fermentation processes from Bacillus polymyxa, with significant challenges related to ensuring consistency, purity, and load stability. The compound’s toxicity also necessitates strict handling protocols, increasing production costs.

Supply Chain Constraints
Global supply is constrained by limited manufacturing capacity, regulatory barriers, and raw material shortages—particularly of specific fermentation substrates. Indian and Chinese pharmaceutical companies dominate polymyxin B production, but geopolitical factors and quality assurance issues influence supply stability.

Generic Competition and Market Entry
The patent landscape for polymyxin B has largely expired, facilitating generic competition. While this drives pricing pressure, it also sustains widespread availability, especially in low- and middle-income countries (LMICs). However, differentiation through formulation quality and safety profiles remains a market driver.

---

Competitive Landscape and Market Participants

Major players include Kingfisher Biotech, The Indian generic manufacturers, and new entrants exploring proprietary formulations. Companies such as Fuzhou FHQ Pharmaceutical and Hainan Kangqiao Pharmaceutical command significant shares, leveraging cost advantages in manufacturing.

Emerging biotech firms are exploring structural modifications or novel delivery mechanisms—such as liposomal encapsulations—to improve tolerability and efficacy, positioning themselves for premium pricing segments.

---

Market Size and Financial Trajectory

Current Market Valuation
The global polymyxin B sulfate market was valued at approximately USD 250-300 million in 2022, with demand primarily driven by hospital and ICU use in Asia-Pacific, North America, and Europe. The Asia-Pacific region accounts for over 50% of consumption, stimulated by high infectious disease burdens and AMR prevalence.

Growth Prospects and Forecasts
The compound annual growth rate (CAGR) for the segment is projected between 7-10% over the next five years, driven by:

• Accelerating AMR crisis escalating demand for last-line antibiotics
• Increasing approval of generic formulations reducing costs
• Expanding use in combination therapies for multidrug-resistant infections
• Rising healthcare infrastructure investments in emerging markets

Impact of Innovative Formulations
Development of newer formulations, including liposomal or inhalable polymyxin B, could command premium prices and improve clinical outcomes, positively influencing revenue streams.

Market Risks
Challenges include antimicrobial stewardship initiatives limiting overuse, potential regulatory restrictions, toxicity concerns, and competition from alternative agents like cefiderocol. Moreover, global supply disruptions due to COVID-19 or geopolitical conflicts may temporarily impact market growth.

---

Financial Trajectories and Investment Outlook

Revenue Streams and Profitability
For mature manufacturers, polymyxin B sulfate offers stable, though modest, revenue streams with high margins historically driven by cost-efficient generic production. Future revenue growth hinges on expanding indications, formulations, and geographic access.

Investment Opportunities
Strategic investors may focus on:

• Funding R&D for advanced formulations and delivery systems
• Acquisition of manufacturers with proven fermentation expertise
• Collaborations with biotech firms exploring combinatory therapies

M&A and Consolidation Trends
The market is witnessing consolidation, with larger pharma firms acquiring or partnering with regional producers to ensure supply reliability and local market penetration.

---

Global Health and Policy Implications

Access and Affordability
In LMICs, polymyxin B remains a critical antibiotic owing to affordability and availability. Policies promoting generic manufacturing and donor programs support broader access, underpinning sustained demand.

Stewardship and Resistance Management
Global initiatives, including WHO guidelines, advocate prudent use of polymyxin B to delay resistance emergence. These policies may temper future growth but are essential for sustainable market evolution.

Environmental and Safety Concerns
Environmental impacts of polymyxin B excretion and safety concerns for healthcare workers handling the drug influence manufacturing standards and occupational safety protocols, potentially increasing operational costs.

---

Conclusion

Polymyxin B sulfate's market trajectory reflects a complex interplay of clinical necessity, manufacturing challenges, regulatory environments, and global health priorities. While the overall market is expected to expand at a notable CAGR driven by rising antimicrobial resistance, sustainability depends on balancing antimicrobial stewardship with access. Innovation in formulations and strategic investments will likely define the financial success and longevity of polymyxin B in the antimicrobial arsenal.

---

Key Takeaways

• The polymyxin B sulfate market is poised for growth driven by increasing antimicrobial resistance and pressing clinical need for last-line antibiotics.
• Manufacturing complexities and raw material constraints influence supply stability and pricing, especially in the context of generic competition.
• Major growth opportunities lie in new formulations, combination therapies, and expanding access in emerging markets.
• Regulatory policies emphasizing stewardship may temper demand but are essential for sustainable use.
• Strategic investments in innovation and supply chain resilience are critical for capitalizing on future market trajectories.

---

FAQs

1. What factors are driving the renewed demand for polymyxin B sulfate?
The primary drivers include the rise of multidrug-resistant Gram-negative infections, limited alternative treatments, and regulatory shifts enabling wider clinical application.

2. How does manufacturing complexity impact the global supply of polymyxin B sulfate?
Its fermentation-based production, quality assurance requirements, and raw material constraints limit manufacturing capacity, leading to supply bottlenecks and pricing variability.

3. What role do emerging markets play in the polymyxin B sulfate market?
Emerging markets constitute a significant consumption base due to high infectious disease burdens and affordability considerations, influencing supply and pricing dynamics.

4. How might new formulations influence the market's financial outlook?
Innovative formulations offering improved safety and efficacy could command premium pricing, extend patent protection, and create new revenue streams.

5. What are the primary regulatory considerations affecting polymyxin B sulfate?
Regulatory agencies focus on safety, quality assurance, and stewardship guidelines, which influence manufacturing standards, approval pathways, and usage protocols.

---

Sources

1. Centers for Disease Control and Prevention (CDC). Antibiotic Resistance Threats Report, 2019.
2. World Health Organization. Global antimicrobial resistance surveillance system (GLASS).
3. MarketsandMarkets. Antibiotics Market Forecast, 2022-2027.
4. U.S. FDA. Guidance for Industry: Safety, Efficacy, and Quality Considerations for Antibiotic Development.
5. Industry reports and peer-reviewed research on polymyxin B manufacturing and clinical application.