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Last Updated: December 22, 2024

COLISTIN SULFATE - Generic Drug Details


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

Colistin sulfate is the generic ingredient in one branded drug marketed by Parke Davis and Endo Operations, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for colistin sulfate.

Summary for COLISTIN SULFATE
US Patents:0
Tradenames:1
Applicants:2
NDAs:2
Drug Master File Entries: 4
Clinical Trials: 5
DailyMed Link:COLISTIN SULFATE at DailyMed
Recent Clinical Trials for COLISTIN SULFATE

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

SponsorPhase
Madonna Magdy FahmyEarly Phase 1
National Cancer Institute, EgyptPhase 4
Stephen HarbarthPhase 2

See all COLISTIN SULFATE clinical trials

Medical Subject Heading (MeSH) Categories for COLISTIN SULFATE

US Patents and Regulatory Information for COLISTIN SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parke Davis COLY-MYCIN S colistin sulfate SUSPENSION;ORAL 050355-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Endo Operations COLY-MYCIN S colistin sulfate; hydrocortisone acetate; neomycin sulfate; thonzonium bromide SUSPENSION/DROPS;OTIC 050356-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  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

COLISTIN SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Colistin Sulfate

Introduction to Colistin Sulfate

Colistin sulfate is a polymyxin antibiotic used to treat bacterial infections caused by susceptible Gram-negative bacteria. It is particularly effective against multidrug-resistant bacteria, making it a crucial option in the fight against antibiotic-resistant infections[2].

Market Size and Growth

The global colistin sulfate market is experiencing steady growth driven by several key factors. As of 2023, the market size was valued at USD 0.059 billion and is projected to reach USD 0.078 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 3.1% during the forecast period[1].

Driving Factors

The increasing prevalence of multidrug-resistant infections is a significant driver of the colistin sulfate market. The demand for cost-effective antibiotics that can combat these resistant bacteria is on the rise, contributing to the market's growth. Additionally, the use of colistin sulfate as an additive in livestock feed to promote growth and treat intestinal infections further boosts its demand[1][4].

Key Applications

Colistin sulfate has several key applications:

  • Human Health: It is used to treat severe infections caused by carbapenem-resistant organisms (CROs), including infections such as CRPA, CRAB, and CRKP. The clinical improvement rate for patients treated with colistin sulfate is notable, with a rate of 70.5% observed in recent studies[5].
  • Livestock: It is used as an additive in animal feed, particularly for pigs and chickens, to promote growth and treat intestinal infections. This application is significant in regions where animal-based food production is high[4].

Regional Analysis

The market for colistin sulfate is geographically diverse, with different regions contributing to its growth:

  • Asia-Pacific: This region dominates the colistin sulfate market due to strong economic growth in developing economies and increasing living standards. Countries like China, India, and Japan are key contributors to this growth[4].
  • North America: Strict regulations regarding meat quality and the high availability of raw materials in this region are expected to drive significant growth in the colistin sulfate market[4].
  • Europe: The market in Europe is also growing, driven by the need for effective antibiotics against multidrug-resistant bacteria and the use of colistin sulfate in veterinary medicine[1].

Competitive Landscape

The colistin sulfate market is competitive, with several key players:

  • Xellia Pharmaceuticals
  • Tecoland
  • Clearsynth
  • JSN Chemicals
  • SNA Health Care
  • HBCChem
  • U.K. Vet Chem
  • Meiji
  • Fengchen Group
  • Fujian Lifecome Biochemistry
  • Sinopharm[1]
  • Hebei Shengxue Dacheng Pharmaceutical Tangshan Co., Ltd.
  • APELOA
  • Livzon
  • Biok Chemical
  • Lifecome Care
  • Shandong Lukang Pharmaceutical Co., Ltd.[4]

These companies are focusing on expanding their product portfolios and strengthening their market presence through strategic initiatives.

Market Challenges and Opportunities

Despite the growth, the colistin sulfate market faces several challenges:

  • Resistance Mechanisms: The emergence of colistin resistance mechanisms, particularly in Enterobacteriaceae strains capable of producing carbapenemase, poses a significant challenge. This resistance can make the bacteria resilient to both colistin and carbapenems, which is a global health concern[4].
  • Regulatory Restrictions: In some advanced countries, the use of colistin in animal feed has been banned due to its potential adverse effects, which can impede market growth[4].

However, there are also opportunities:

  • Technological Advancements: Technological developments aimed at reducing resistance in Gram-negative bacteria could provide potential opportunities for the growth of the colistin sulfate market[4].
  • Increasing Demand for Antibiotics: The ongoing need for effective antibiotics against multidrug-resistant bacteria ensures a steady demand for colistin sulfate[1].

Financial Trajectory

The financial trajectory of the colistin sulfate market is positive, with steady growth projected over the next decade. Here are some key financial metrics:

  • Market Size: Expected to reach USD 0.078 billion by 2032[1].
  • CAGR: Projected to grow at a CAGR of 3.1% from 2023 to 2032[1].
  • Revenue Growth: The market is expected to witness significant revenue growth driven by increasing demand and expanding applications[4].

Segment Analysis

The market is segmented based on types and applications:

  • Types: Colistin sulfate API, colistin sulfate premix, and others[4].
  • Applications: Pig, chicken, and other livestock segments. The pig segment is expected to expand at a significant CAGR throughout the forecast period[3].

Key Takeaways

  • The global colistin sulfate market is growing due to the increasing demand for effective antibiotics against multidrug-resistant bacteria.
  • The market is driven by its use in human health and livestock feed.
  • Asia-Pacific and North America are key regions driving market growth.
  • The market faces challenges such as resistance mechanisms and regulatory restrictions but also has opportunities for growth through technological advancements.
  • Key players are focusing on expanding their product portfolios and market presence.

FAQs

Q: What is the expected market size of the global colistin sulfate market by 2032? A: The global colistin sulfate market is expected to reach USD 0.078 billion by 2032[1].

Q: What is the CAGR of the global colistin sulfate market from 2023 to 2032? A: The global colistin sulfate market is expected to exhibit a CAGR of 3.1% from 2023 to 2032[1].

Q: What are the primary applications of colistin sulfate? A: Colistin sulfate is used in human health to treat infections caused by multidrug-resistant bacteria and in livestock feed to promote growth and treat intestinal infections[4][5].

Q: Which regions dominate the colistin sulfate market? A: Asia-Pacific and North America are the dominant regions in the colistin sulfate market[4].

Q: What are the major challenges facing the colistin sulfate market? A: The major challenges include the emergence of resistance mechanisms and regulatory restrictions in some countries[4].

Citations

  1. Business Research Insights: Colistin Sulfate Market Size, Share, Growth Research Report, 2032.
  2. DrugBank Online: Colistin: Uses, Interactions, Mechanism of Action.
  3. Cognitive Market Research: Colistin Sulphate Market Report 2024 (Global Edition).
  4. Data Bridge Market Research: Global Colistin Sulphate Market - Industry Trends and Forecast to 2029.
  5. Journal of Thoracic Disease: Efficacy and safety of colistin sulfate in the treatment of infections.

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