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Last Updated: December 22, 2024

GENTIAN VIOLET - Generic Drug Details


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

Gentian violet is the generic ingredient in two branded drugs marketed by Savage Labs and Key Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for GENTIAN VIOLET
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Recent Clinical Trials for GENTIAN VIOLET

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SponsorPhase
Wake Forest University Health SciencesPhase 2
Assiut UniversityN/A
Khon Kaen HospitalN/A

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Medical Subject Heading (MeSH) Categories for GENTIAN VIOLET

US Patents and Regulatory Information for GENTIAN VIOLET

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Savage Labs GVS gentian violet SUPPOSITORY;VAGINAL 083513-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Key Pharms GENAPAX gentian violet TAMPON;VAGINAL 085017-001 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

GENTIAN VIOLET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Gentian Violet

Introduction

Gentian violet, a triphenylmethane dye mixture, has been in use for over a century due to its versatile applications in medicine, textiles, and other industries. This article delves into the market dynamics and financial trajectory of gentian violet, exploring its production, uses, regulatory landscape, and market trends.

Production and Supply Chain

Global Production

Gentian violet is primarily produced in India and China, which are the largest manufacturers of this dye. In the United States, production volumes have varied significantly over the years, ranging from 500,000 to 1 million pounds per year in the late 1980s to between 10,000 and 500,000 pounds per year in the late 1990s and early 2000s[1].

Import and Export

The European Union does not produce gentian violet but imports between 210-230 tonnes annually. In 2020, gentian violet was available from numerous suppliers globally, including 36 in China, 15 in the USA, 9 in India, and 2 in Europe[1].

Uses and Applications

Medical Applications

Gentian violet is widely used as an antibacterial, antifungal, and anthelmintic agent. It is effective against Gram-positive bacteria, certain viral infections, and parasitic infections. It is used in clinical and bacteriological laboratories for staining biological specimens and in the Gram staining method to distinguish between Gram-positive and Gram-negative bacteria[1][2].

Industrial Applications

Beyond medicine, gentian violet is used as a dye for textiles, paper, and various industrial products such as ballpoint pen ink, paint, plastic, and gasoline. It is also used in food-packaging materials and as a hair dye, although its use in livestock feed has been discontinued due to safety concerns[1][2].

Regulatory Landscape

FDA and International Regulations

In the United States, the FDA regulates gentian violet as a nonprescription drug for human use but has not approved it for veterinary use. The FDA has determined that gentian violet is not generally recognized as safe and effective for use in animal feed or as a therapeutic agent in animals[4].

Health Canada and International Standards

Health Canada has conducted risk assessments that indicate gentian violet may cause cancer based on animal studies. Consequently, manufacturers have voluntarily discontinued the sale of gentian violet-containing products in Canada. The FAO/WHO Joint Expert Committee on Food Additives has also recommended preventing exposure to gentian violet residues in food due to its genotoxic and carcinogenic properties[3].

Market Trends and Financial Trajectory

Market Size and Growth

While specific financial data on the gentian violet market is limited, the broader market for triphenylmethane dyes, which includes gentian violet, is influenced by demand from various sectors such as textiles, healthcare, and industrial applications. The global market for such dyes is expected to grow, driven by increasing demand for antimicrobial and antifungal agents in healthcare and industrial settings.

Challenges and Opportunities

The market for gentian violet faces significant challenges due to regulatory restrictions, particularly in veterinary and food applications. However, its continued use in human medicine and industrial sectors provides a stable market base. The development of new applications, such as in chromoendoscopy and as a pH indicator, also presents opportunities for growth[1][2].

Competitive Landscape

The market for gentian violet is characterized by a diverse set of suppliers, with a significant presence in China, the USA, and India. The availability of gentian violet from multiple suppliers suggests a competitive market, which can influence pricing and market dynamics[1].

Financial Implications

Revenue Streams

Revenue from gentian violet is generated through its sale as a nonprescription drug, industrial dye, and in various medical and laboratory applications. The financial performance of companies involved in the production and distribution of gentian violet would be influenced by the demand from these sectors and the regulatory environment.

Cost Factors

Production costs, import tariffs, and regulatory compliance expenses are key factors that affect the financial trajectory of gentian violet. The discontinuation of its use in certain applications, such as livestock feed, has likely impacted revenue streams for some manufacturers[3][4].

Key Takeaways

  • Global Production: Primarily produced in India and China, with significant imports by the European Union.
  • Versatile Applications: Used in medicine, textiles, and industrial products.
  • Regulatory Challenges: Restricted in veterinary and food applications due to safety concerns.
  • Market Growth: Driven by demand in human medicine and industrial sectors.
  • Competitive Market: Multiple suppliers globally, influencing pricing and market dynamics.

FAQs

What are the primary uses of gentian violet?

Gentian violet is used as an antibacterial, antifungal, and anthelmintic agent in medicine, as a dye for textiles and industrial products, and in laboratory staining techniques.

Is gentian violet safe for use in animals?

The FDA has not approved gentian violet for veterinary use, and Health Canada has discontinued its use in veterinary products due to safety concerns.

Why is gentian violet restricted in food applications?

Gentian violet is considered a genotoxic carcinogen by the FAO/WHO Joint Expert Committee on Food Additives, leading to recommendations to prevent its use in food.

What are the main production regions for gentian violet?

India and China are the largest producers of gentian violet.

How does the regulatory landscape impact the market for gentian violet?

Regulatory restrictions, particularly in veterinary and food applications, have reduced revenue streams for some manufacturers but have not significantly impacted its use in human medicine and industrial sectors.

Sources

  1. NCBI: Gentian Violet and Leucogentian Violet.
  2. OEHHA: Gentian Violet.
  3. Health Canada: Summary Safety Review - Gentian violet-containing human health products.
  4. GAO: FDA's Regulation Of Gentian Violet Appears Reasonable.

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