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Last Updated: April 18, 2025

Polymyxin-class Antibacterial Drug Class List


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Drugs in Drug Class: Polymyxin-class Antibacterial

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Bausch And Lomb BACITRACIN ZINC AND POLYMYXIN B SULFATE bacitracin zinc; polymyxin b sulfate OINTMENT;OPHTHALMIC 064046-001 Jan 26, 1995 AT RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Casper Pharma Llc CASPORYN HC hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 060613-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Fresenius Kabi Usa COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 065364-001 Apr 17, 2008 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Padagis Us BACITRACIN ZINC AND POLYMYXIN B SULFATE bacitracin zinc; polymyxin b sulfate OINTMENT;OPHTHALMIC 065022-001 Feb 27, 2002 AT RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Padagis Us BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE bacitracin zinc; hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 062166-002 Approved Prior to Jan 1, 1982 RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Xellia Pharms Aps COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 205356-001 May 29, 2015 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 6 of 6 entries

Polymyxin-class Antibacterial Market Analysis and Financial Projection

The polymyxin-class antibiotics market is experiencing significant growth driven by the critical need to combat multidrug-resistant Gram-negative bacterial infections, while ongoing patent expirations and next-generation innovations reshape the competitive landscape.

Market Dynamics

The global polymyxins market was valued at $1.2 billion in 2024 and is projected to reach $2.5 billion by 2033, growing at a 9.2% CAGR [2][12]. This growth is fueled by:

  • Rising antibiotic resistance: Gram-negative bacteria cause ~2.8 million infections annually in the U.S., with polymyxins often serving as last-resort treatments [2].
  • Expanding applications: Use in veterinary medicine and agriculture (76,000 tons of antibiotics used globally in livestock in 2021) amplifies demand but raises resistance concerns [2].
  • Geographic trends: Asia-Pacific leads growth due to high antibiotic consumption, while North America remains dominant in R&D and advanced diagnostics [2][5].

The polymyxin resistance testing market is growing at a 6.2% CAGR, expected to reach $222.5 million by 2033, driven by the need for precision in diagnosing resistant strains like carbapenem-resistant Enterobacteriaceae [5][8].

Patent Landscape

Key Developments:

  1. Novel Derivatives:

    • Patents like US 8906866 and US 8889826 cover reduced-toxicity polymyxin A/B derivatives, with claims spanning compositions and production methods [1].
    • Monash University’s QPX9003, a next-gen polymyxin with improved safety, entered Phase I trials in 2021 [9].
  2. Manufacturing Innovations:

    • Patent US 7951913 outlines improved polymyxin B recovery from fermentation broth, enhancing production efficiency [4].
  3. Combination Therapies:

    • US 8193148 describes polymyxin derivatives with three positive charges at physiological pH, designed for synergistic use with other antibiotics [1].

Patent Expirations and Generics:

  • Major brands like Vigamox and Zymaxid face patent cliffs, accelerating generic competition [3].
  • The U.S. polymyxin B sulfate market is projected to grow at 6.2% CAGR through 2033, with generics pressuring branded drug revenues [12].

Competitive and Innovation Trends

Factor Impact
R&D Investments NIAID and CARB-X have funded >$25 million for polymyxin research since 2012 [11].
Antibiotic Stewardship Programs optimize polymyxin use to delay resistance, affecting prescribing patterns [2][5].
Pipeline Developments Spero Therapeutics’ SPR741 (a polymyxin adjuvant) and Qpex Biopharma’s QPX9003 highlight next-gen efforts [9][11].

Challenges and Opportunities

  • Toxicity Concerns: Up to 60% of patients experience nephrotoxicity with current polymyxins, driving demand for safer variants [9].
  • Diagnostic Integration: Resistance testing platforms are critical for targeted therapy, with automated systems accelerating adoption [5][8].
  • Agricultural Overuse: Regulatory frameworks are needed to curb non-therapeutic use in livestock, a key resistance driver [2].

Future Outlook

The market will hinge on balancing generics’ cost benefits with innovative derivatives offering improved safety profiles. Strategic collaborations (e.g., BioSource Pharm and Cubist Pharmaceuticals [1]) and AI-driven drug discovery platforms could streamline development. With antimicrobial resistance projected to cause 10 million annual deaths by 2050, polymyxins remain a cornerstone of infection management, albeit with evolving utilization protocols.

“The resurgence of polymyxins underscores their irreplaceable role in modern medicine, but their longevity depends on judicious use and continuous innovation.” – Adaptation from Monash University research [9].

References

  1. https://patents.justia.com/patents-by-us-classification/530/319
  2. https://www.verifiedmarketreports.com/product/polymyxins-market-size-and-forecast/
  3. https://www.transparencymarketresearch.com/us-bacterial-conjunctivitis-drugs-market.html
  4. https://patents.justia.com/patent/7951913
  5. https://www.persistencemarketresearch.com/market-research/polymyxin-resistance-testing-market.asp
  6. https://straitsresearch.com/report/antibiotics-market
  7. https://pubs.acs.org/doi/10.1021/bc500094d
  8. https://www.futuremarketinsights.com/reports/polymyxin-resistance-testing-market
  9. https://research.unimelb.edu.au/facilities/infrastructure/phenomics-australia-histopathology-and-slide-scanning-service/identifying-a-new-polymyxin-for-antibiotic-drug-development
  10. https://github.com/haklagjbj/Market-Research-Report-List-1/blob/main/polymyxin-b-sulfate-market.md
  11. https://www.frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2019.01689/full
  12. https://www.verifiedmarketreports.com/product/multi-polymyxin-b-sulfate-market-insights-2019-global-and-chinese-analysis-and-forecast-to-2024/

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