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Last Updated: December 22, 2024

POLYMYXIN B SULFATE Drug Patent Profile


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When do Polymyxin B Sulfate patents expire, and what generic alternatives are available?

Polymyxin B Sulfate is a drug marketed by Adrastea Pharma, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Rising, Xellia Pharms Aps, and Paddock Llc. and is included in eight NDAs.

The generic ingredient in POLYMYXIN B SULFATE is polymyxin b sulfate. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Polymyxin B Sulfate

A generic version of POLYMYXIN B SULFATE was approved as polymyxin b sulfate by ADRASTEA PHARMA on September 30th, 1994.

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Summary for POLYMYXIN B SULFATE
Drug patent expirations by year for POLYMYXIN B SULFATE
Recent Clinical Trials for POLYMYXIN B SULFATE

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

SponsorPhase
Madonna Magdy FahmyEarly Phase 1
Bascom Palmer Eye InstituteN/A
University of MiamiN/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
Adrastea Pharma POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 063000-001 Sep 30, 1994 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Xellia Pharms Aps POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 202766-001 Jan 15, 2014 AP RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Gland POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 207322-001 Apr 14, 2016 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Paddock Llc POLYMYXIN B SULFATE polymyxin b sulfate POWDER;FOR RX COMPOUNDING 062455-001 Jul 27, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Eugia Pharma POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 206589-001 Apr 4, 2016 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fresenius Kabi Usa POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 065372-001 Jan 10, 2008 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>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 Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Polymyxin B Sulfate

Introduction to Polymyxin B Sulfate

Polymyxin B sulfate is an antibiotic derived from the bacterium Bacillus polymyxa, known for its efficacy against Gram-negative bacteria. It is used in various medical applications, including the treatment of urinary tract, meningeal, and bloodstream infections, as well as surface ocular bacterial infections[2][3].

Market Size and Growth Projections

The global Polymyxin B Sulfate Market has experienced significant growth in recent years and is expected to continue this upward trend. As of 2023, the market size was valued at approximately USD 320 million. Projections indicate that the market will expand to reach around USD 520 million by 2032[4].

Historical and Forecast Periods

The market analysis spans from 2021 to 2031, with 2023 serving as the base year. The historical period from 2021 to 2023 has shown a rapid and substantial upswing, and this growth is anticipated to continue through the forecast period from 2024 to 2031[1].

Segmentation of the Market

The Polymyxin B Sulfate Market is segmented based on several key factors:

By Type

  • Tablets: Used for oral administration, often in cases of less severe infections.
  • Injections: Administered intravenously or intramuscularly for more severe infections[1].

By Application

  • Hospitals: A major segment due to the frequent use of polymyxin B sulfate in treating severe infections.
  • Private Clinics: Also a significant segment, especially for outpatient treatments.
  • Others: Includes other healthcare facilities and home care settings[1].

By Geography

  • North America: A significant market due to advanced healthcare infrastructure and high demand.
  • Europe: Another major market with a strong healthcare system.
  • Asia-Pacific: Rapidly growing due to increasing healthcare needs and infrastructure development.
  • South America: Growing steadily with improving healthcare access.
  • Middle-East and Africa: Emerging markets with increasing demand for advanced antibiotics[1].

Market Drivers and Restraints

Drivers

  • Increasing Resistance to Other Antibiotics: The rise in antibiotic-resistant bacteria has increased the demand for polymyxin B sulfate as a last-resort treatment[3].
  • Advancements in Healthcare Infrastructure: Improved healthcare facilities and access to advanced treatments in various regions drive the market growth.
  • Growing Prevalence of Infections: The increasing incidence of infections, particularly those caused by Gram-negative bacteria, fuels the demand for polymyxin B sulfate[1].

Restraints

  • Nephrotoxicity and Other Adverse Effects: Polymyxin B sulfate can cause nephrotoxicity and other adverse effects, which can limit its use and impact market growth[3].
  • Regulatory Challenges: Strict regulatory environments and the need for careful monitoring of side effects can slow market expansion.
  • High Cost: The drug's high cost can be a barrier to access, especially in developing regions[1].

Competitive Landscape

The Polymyxin B Sulfate Market is characterized by a mix of established and emerging players. Key companies profiled in the market include:

  • AKORN
  • Allergan
  • BAUSCH AND LOMB
  • FRESENIUS KABI USA
  • SANDOZ INC
  • XELLIA PHARMS APS
  • Concord Biotech
  • AuroMedics[1].

These companies are profiled based on their product offerings, market entry year, and other relevant market-related factors.

Market Outlook and Trends

Porter's 5 Forces Framework

The market analysis includes an in-depth examination using Porter's 5 Forces Framework, which considers the threat of new entrants, the threat of substitute products, the bargaining power of buyers, the bargaining power of suppliers, and the intensity of competitive rivalry. This framework helps in understanding the competitive dynamics and potential future trends[1].

Macroeconomic Evaluation

The report also includes a macroeconomic evaluation, scrutinizing the economic, political, and social landscapes of various countries. This helps in predicting how external factors might influence the market[1].

Value Chain Analysis

A comprehensive value chain analysis is conducted to understand the flow of goods and services from raw materials to end consumers. This analysis highlights critical areas that can be optimized to enhance market performance[1].

Financial Performance and Projections

Revenue Growth

The market is expected to grow significantly, with revenue projected to increase from USD 320 million in 2023 to USD 520 million by 2032. This growth is driven by increasing demand, advancements in healthcare, and the expanding reach of the drug into new markets[4].

Pricing Analysis

The report includes a detailed pricing analysis, which considers the pricing strategies of key players, the extent of product penetration at national and regional levels, and the impact of pricing on market dynamics. This analysis helps in understanding how pricing influences the financial trajectory of the market[1].

Key Takeaways

  • Rapid Market Growth: The Polymyxin B Sulfate Market is experiencing rapid growth due to increasing demand and limited alternatives.
  • Segmentation: The market is segmented by type, application, and geography, each contributing to its overall growth.
  • Drivers and Restraints: The market is driven by antibiotic resistance and healthcare advancements but restrained by nephrotoxicity and regulatory challenges.
  • Competitive Landscape: The market features a mix of established and emerging players, with key companies playing significant roles.
  • Financial Projections: The market is projected to reach USD 520 million by 2032, driven by revenue growth and expanding market reach.

FAQs

What are the primary uses of Polymyxin B Sulfate?

Polymyxin B sulfate is primarily used to treat infections caused by Gram-negative bacteria, including urinary tract, meningeal, and bloodstream infections, as well as surface ocular bacterial infections[2][3].

Which regions are driving the growth of the Polymyxin B Sulfate Market?

North America, Europe, and the Asia-Pacific region are significant drivers of the market growth due to their advanced healthcare infrastructure and high demand for antibiotics[1].

What are the major challenges facing the Polymyxin B Sulfate Market?

The market faces challenges such as nephrotoxicity, high cost, and regulatory hurdles, which can limit its growth and adoption[1][3].

Who are the key players in the Polymyxin B Sulfate Market?

Key players include AKORN, Allergan, BAUSCH AND LOMB, FRESENIUS KABI USA, SANDOZ INC, XELLIA PHARMS APS, Concord Biotech, and AuroMedics[1].

What is the projected market size of Polymyxin B Sulfate by 2032?

The market is projected to reach approximately USD 520 million by 2032[4].

Sources

  1. Market Research Intellect: Global Polymyxin B Sulfate Market Size, Scope And Forecast Report.
  2. DailyMed: Polymyxin B sulfate and trimethoprim sulfate solution/drops.
  3. DrugBank: Polymyxin B: Uses, Interactions, Mechanism of Action.
  4. Dataintelo: Global Polymyxin B Sulfate Market Research Report 2032.

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