Last Updated: May 11, 2026

POLYMYXIN B SULFATE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for polymyxin b sulfate and what is the scope of patent protection?

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

SponsorPhase
Madonna Magdy FahmyEarly Phase 1
University of MiamiN/A
Bascom Palmer Eye InstituteN/A

See all POLYMYXIN B SULFATE clinical trials

Pharmacology for POLYMYXIN B SULFATE
Medical Subject Heading (MeSH) Categories for POLYMYXIN B SULFATE

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
Fresenius Kabi Usa POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 065372-001 Jan 10, 2008 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Rising POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 090110-001 Jun 29, 2011 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Eugia Pharma POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 206589-001 Apr 4, 2016 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Xellia Pharms Aps POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 202766-001 Jan 15, 2014 AP RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Paddock Llc POLYMYXIN B SULFATE polymyxin b sulfate POWDER;FOR RX COMPOUNDING 062455-001 Jul 27, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Gland POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 207322-001 Apr 14, 2016 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Polymyxin B Sulfate: Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

What market is Polymyxin B Sulfate in?

Polymyxin B sulfate is an old-generation, parenteral polymyxin antibiotic used for serious Gram-negative infections, including multidrug-resistant (MDR) pathogens. Its market is shaped less by chronic demand drivers and more by:

  • Acute-care hospital procurement cycles (formulary placement, distributor contracting, and tender timing)
  • Guideline-driven use during outbreaks or periods of high resistance
  • Competitive displacement from newer polymyxins, beta-lactam/beta-lactamase inhibitor combinations, carbapenems when susceptible, and newer agents for resistant Gram-negative bacteria
  • Constrained supply and manufacturing risk common to older antibiotic supply chains (specialized active ingredient sourcing and sterile manufacturing capacity)

In market terms, Polymyxin B sulfate behaves like a reserve/last-line hospital antibiotic: volumes rise when resistance is high and when stewardship panels favor older salvage options; volumes compress when alternatives are preferred or when susceptibility patterns change.

How does resistance and stewardship drive demand?

Demand for Polymyxin B sulfate is directly linked to the incidence of resistant Gram-negative infections where it remains clinically relevant:

  • Higher MDR burden supports use and maintains hospital inventory levels
  • Antimicrobial stewardship can cap use duration and restrict initiation to microbiology-confirmed indications, which compresses “script-like” demand and increases variability at the facility level
  • Local antibiograms drive switching behavior between polymyxins and newer rescue therapies

Economic translation: Polymyxin B sulfate revenues tend to track hospital severity mix and resistance prevalence, not population growth. That creates demand volatility by geography and by year.

What does the competitive landscape do to pricing power?

Pricing power for Polymyxin B sulfate is typically limited by:

  • Generic competition (the molecule has long been marketed and is widely available in many jurisdictions)
  • Hospital bulk contracting that drives unit price down over time
  • Substitution within the “resistant Gram-negative” bucket, where clinicians choose among active options based on susceptibility, renal considerations, and local formulary preferences

Competitive pressure shifts revenue from high-margin brand-like dynamics to procurement-led economics. In that setting, financial trajectory is dominated by:

  • Unit price obtained in tenders and contracts
  • Case volume treated with polymyxins
  • Reimbursement environment (more stable in hospital settings than outpatient, but still subject to payer and bundled payment structures)

What are the main market dynamics that can expand or shrink volumes?

Expansion levers

  • Increasing prevalence of MDR Gram-negative infections in ICUs
  • Limited availability or higher cost of alternative rescue agents
  • Clinical inclusion in hospital treatment pathways for specific phenotypes (susceptibility profile, severity, and renal status management)

Contraction levers

  • Broader access to newer agents that reduce polymyxin reliance
  • Stewardship tightening that discourages empiric polymyxin use unless criteria are met
  • Variation in susceptibility patterns that lowers the fraction of cases where polymyxins are the best available option

How is the market impacted by safety and administration constraints?

Polymyxin class antibiotics have known renal and neurotoxicity risks, which affects use patterns and can constrain throughput:

  • Clinicians may delay initiation until susceptibility or severity thresholds are met
  • Dose adjustments and monitoring requirements can slow uptake in borderline cases
  • Hospital protocols influence how often polymyxins are selected compared with alternatives that require less intensive monitoring

Economically, safety constraints do not eliminate demand, but they concentrate use into high-need cases, which increases price competition while limiting predictable volume growth.

What is the likely sales model and buyer profile?

The buyer profile is hospital and integrated delivery networks:

  • Procurement teams negotiate supply and pricing through distributors
  • Pharmacy and infectious disease departments influence formulary inclusion and stewardship policies
  • Pharmacy compounding and sterile manufacturing quality systems determine which suppliers can reliably meet demand

The sales model is therefore supply and contract driven, not marketing driven.

Financial trajectory: what tends to happen over time for Polymyxin B sulfate?

For older, widely available hospital antibiotics, financial trajectories usually follow a pattern:

  1. Early period (original launch or premium positioning): higher unit pricing, lower competitive intensity
  2. Consolidation period (generic expansion): unit price declines, revenues become volume-sensitive and contract-dependent
  3. Maturity period: revenue stays relatively stable or declines slightly in value terms, with occasional spikes during resistance surges or supply disruptions

For Polymyxin B sulfate specifically, the maturity-phase dynamics dominate. Any observed revenue changes are usually driven by:

  • Changes in ICU resistance prevalence (case count)
  • Changes in procurement unit economics (tender outcomes, distributor pricing, and discounting)
  • Periodic supply constraints that can temporarily increase contracting leverage and raise realized prices

What do unit economics look like in hospital antibiotic markets?

Even without molecule-specific financial disclosures in the public record, the unit economics are structurally consistent in this category:

  • Revenue per treated case depends on dose, duration, and formulation.
  • Realized net price depends on contract terms and payer/bundled structures.
  • Gross margin is constrained by:
    • Sterile supply chain costs
    • API sourcing volatility
    • Competitive bidding for hospital tenders

For an older antibiotic like Polymyxin B sulfate, the principal lever to improve net revenue is often service reliability and contract wins, not product differentiation.

Are there patent or exclusivity effects that can shape the financial curve?

Polymyxin B sulfate is not typically characterized by long, near-term exclusivity windows in mature markets because the active substance is established and multiple manufacturers exist. As a result:

  • The financial curve is less about blockbuster-type exclusivity and more about competitive entry timing, regulatory and manufacturing approvals, and supply chain stability.
  • Patent value, where present, is more likely tied to formulation, manufacturing process, or regulatory exclusivities rather than the base active ingredient.

What does the investment lens imply for revenue stability?

For investors, Polymyxin B sulfate’s revenue profile is usually:

  • Resilient to demand shocks because hospitals use it as a reserve option when needed
  • Sensitive to procurement pricing because generic availability intensifies competition
  • Sensitive to guideline shifts and substitution patterns among resistant Gram-negative therapies
  • Exposed to supply disruptions that can create short-term revenue swings but long-term reputational and contracting risk

Market and financial trajectory summary

Polymyxin B sulfate sits in the high-resistance, high-acuity, hospital antibiotic market where demand is driven by MDR prevalence and stewardship criteria, while revenue growth is limited by generic competition and procurement contracting. Financial performance typically tracks resistance trends and tender outcomes, with no strong long-duration pricing moat.


Key Takeaways

  • Polymyxin B sulfate demand is acute-care and resistance-driven, with stewardship restricting predictable, broad-based use.
  • Revenue trajectory is procurement-led: unit price and contract wins matter more than product differentiation.
  • Generic availability and substitution limit sustained pricing power; financial outcomes depend on volume in eligible MDR cases and tender pricing.
  • Safety monitoring requirements concentrate use into severe cases, supporting baseline demand but limiting growth breadth.

FAQs

1) What drives short-term volume swings for Polymyxin B sulfate?

ICU-level resistance prevalence and hospital-specific stewardship thresholds can shift eligible case counts quickly from quarter to quarter.

2) Why does generic competition matter economically here?

Hospitals tender aggressively for older antibiotics; multiple manufacturers reduce pricing power and compress realized net margins.

3) Does stewardship increase or decrease revenues?

It usually decreases low-acuity use and compresses casual prescribing, shifting demand toward high-need cases and increasing variability.

4) What is the biggest risk to financial predictability?

Tender outcome volatility and supply reliability risks, since hospital buyers prioritize contract value and reliable delivery.

5) Is growth likely from new clinical adoption?

Growth can occur if resistance trends shift toward polymyxin-eligible phenotypes or if alternatives face supply or cost pressure, but sustained price growth is unlikely in a mature, generic market.


References

[1] Lexicomp. Polymyxin B Sulfate (systemic). Wolters Kluwer. Accessed 2026.
[2] WHO. Antimicrobial resistance: global report on surveillance. World Health Organization. 2014.
[3] CDC. Antibiotic Resistance Threats in the United States. Centers for Disease Control and Prevention. 2019.
[4] IDSA. Guidance on the treatment of antimicrobial-resistant Gram-negative infections. Infectious Diseases Society of America. Accessed 2026.
[5] Sanford Guide. Gram-Negative Infections and Polymyxins. Antimicrobial Therapy. Accessed 2026.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.