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Last Updated: December 22, 2024

Chloramphenicol - Generic Drug Details


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What are the generic sources for chloramphenicol and what is the scope of patent protection?

Chloramphenicol is the generic ingredient in fourteen branded drugs marketed by Parke Davis, Parkedale, Altana, Pharmafair, Allergan, Alcon, Epic Pharma Llc, Optopics, Elkins Sinn, Fresenius Kabi Usa, Gruppo Lepetit, and Angus, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for chloramphenicol.

Drug Prices for chloramphenicol

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Recent Clinical Trials for chloramphenicol

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

SponsorPhase
Lao-Oxford-Mahosot Hospital Wellcome Trust Research UnitPhase 2/Phase 3
Mahidol Oxford Tropical Medicine Research UnitPhase 2/Phase 3
City, University of LondonN/A

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Medical Subject Heading (MeSH) Categories for chloramphenicol

US Patents and Regulatory Information for chloramphenicol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Optopics OPTOMYCIN chloramphenicol SOLUTION/DROPS;OPHTHALMIC 062171-001 Mar 31, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Parkedale OPHTHOCHLOR chloramphenicol SOLUTION/DROPS;OPHTHALMIC 061220-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Altana CHLORAMPHENICOL chloramphenicol OINTMENT;OPHTHALMIC 060133-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Angus MYCHEL-S chloramphenicol sodium succinate INJECTABLE;INJECTION 060132-001 Approved Prior to Jan 1, 1982 DISCN 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

Chloramphenicol Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Chloramphenicol

Introduction

Chloramphenicol, a broad-spectrum antibiotic, has been a significant player in the pharmaceutical industry since its discovery in 1947. Despite its effectiveness against various bacterial infections, its market dynamics are influenced by several factors, including safety concerns, regulatory changes, and evolving market trends.

Market Size and Growth

The global chloramphenicol market has shown significant growth, driven by various factors. As of 2023, the global chloramphenicol market size was substantial, with a projected compound annual growth rate (CAGR) from 2024 to 2031[1][2].

Segmentation

The chloramphenicol market is segmented based on type and application. The >98% purity segment accounted for a noticeable share of the global chloramphenicol market in 2023 and is expected to experience significant growth in the near future. In terms of application, chloramphenicol eye drops are a key segment, expected to expand at a significant CAGR throughout the forecast period[1][2].

Drivers

Several factors drive the growth of the chloramphenicol market:

Increasing Prevalence of Ophthalmic Disorders

The rise in ophthalmic disorders, particularly among the geriatric population, is a significant driver. Conditions such as dry eye syndrome, which is increasingly prevalent globally, propel the demand for chloramphenicol eye drops[4].

Advancements in Eye Care

The growing awareness of eye care and the easy availability of lubricating eye drops contribute to market growth. Innovations in eye care products, including new product launches, also drive the market forward[4].

Technological Advancements

Technological advancements and the development of new formulations and delivery systems enhance the market's potential. For instance, the acquisition of new treatments like Xiidra (lifitegrast ophthalmic solution) by Novartis in 2019 highlights the industry's commitment to innovation[4].

Restraints

Despite the drivers, there are several restraints that impact the market:

Safety Concerns

Chloramphenicol is associated with high risks of bone marrow toxicity, including fatal aplastic anemia, particularly when administered orally. This has led to the FDA withdrawing all oral drug products containing chloramphenicol, limiting its use to topical and injectable forms[5].

Side Effects

The side effects associated with ophthalmic eye drops, including those containing chloramphenicol, can hamper market growth. These side effects may deter some patients from using these products, despite their effectiveness[4].

Opportunities

The market presents several opportunities for growth:

Expanding Geriatric Population

The increasing geriatric population, which is more prone to ophthalmic disorders, offers a significant opportunity for the chloramphenicol market. This demographic shift is expected to drive demand for eye care products, including chloramphenicol eye drops[4].

Emerging Markets

Regions such as Asia Pacific, Middle East, and Africa offer untapped potential due to growing healthcare needs and increasing awareness of eye care. Companies can expand their business in these regions to capitalize on the growing demand[2].

Competitive Landscape

The competitive landscape of the chloramphenicol market is characterized by several key players:

Major Companies

Companies like Hubei Jusheng Technology and Northeast Pharmaceutical Group are focusing on strategy building and product portfolio expansion to strengthen their market position. Other players, such as Novartis and Dr. Reddy's Laboratories, are also making significant contributions through new product launches and acquisitions[1][2].

Regional Analysis

The market is segmented into major regions including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region has its own set of trends and growth drivers. For instance, the Asia Pacific region is expected to show significant growth due to the large population and increasing healthcare expenditure[2].

Technological Roadmap

The technological roadmap for chloramphenicol involves continuous innovation in formulation and delivery systems. This includes the development of more effective and safer formulations, as well as advancements in manufacturing processes to improve product quality and reduce costs[1].

Financial Analysis

The financial trajectory of the chloramphenicol market is positive, with a projected significant CAGR from 2024 to 2031. The market size is expected to grow substantially, driven by increasing demand and technological advancements.

SWOT Analysis

  • Strengths: Broad-spectrum antibiotic effectiveness, growing demand for eye care products, and technological advancements.
  • Weaknesses: Safety concerns, side effects associated with ophthalmic use, and regulatory restrictions.
  • Opportunities: Expanding geriatric population, emerging markets, and new product launches.
  • Threats: Competition from other antibiotics, regulatory changes, and economic fluctuations[1].

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the chloramphenicol market. While the pandemic has accelerated the development and demand for certain pharmaceutical products, it has also presented challenges such as supply chain disruptions and increased regulatory scrutiny. However, the overall impact on the chloramphenicol market has been manageable, with the market continuing to grow despite these challenges[4].

Key Takeaways

  • The global chloramphenicol market is driven by increasing ophthalmic disorders and technological advancements.
  • Safety concerns and side effects are significant restraints.
  • The market presents opportunities in emerging regions and through new product launches.
  • Key players are focusing on strategy building and product portfolio expansion.
  • The financial trajectory is positive, with a projected significant CAGR.

FAQs

Q: What are the primary drivers of the chloramphenicol market? A: The primary drivers include the increasing prevalence of ophthalmic disorders, advancements in eye care, and technological innovations.

Q: Why is chloramphenicol not frequently used orally? A: Chloramphenicol is not frequently used orally due to its high risk of bone marrow toxicity, including fatal aplastic anemia.

Q: Which segment of the chloramphenicol market is expected to grow significantly? A: The chloramphenicol eye drops segment is expected to expand at a significant CAGR throughout the forecast period.

Q: How has the COVID-19 pandemic impacted the chloramphenicol market? A: The pandemic has had a mixed impact, accelerating demand for some pharmaceutical products but also presenting supply chain and regulatory challenges.

Q: What are the key opportunities for growth in the chloramphenicol market? A: The expanding geriatric population and emerging markets offer significant opportunities for growth.

Cited Sources:

  1. Cognitivemarketresearch.com - Global Chloramphenicol Market Report 2024 Edition
  2. Cognitivemarketresearch.com - Chloramphenicol Eye Drops Market Report 2024 (Global Edition)
  3. Alliedmarketresearch.com - Chloramphenicol Eye Drops Market Share, Trend and Forecast 2030
  4. DrugBank - Chloramphenicol: Uses, Interactions, Mechanism of Action

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