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Last Updated: December 23, 2024

Chlorotrianisene - Generic Drug Details


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What are the generic sources for chlorotrianisene and what is the scope of freedom to operate?

Chlorotrianisene is the generic ingredient in two branded drugs marketed by Banner Pharmacaps and Sanofi Aventis Us, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for chlorotrianisene.

Summary for chlorotrianisene
Recent Clinical Trials for chlorotrianisene

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SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all chlorotrianisene clinical trials

Medical Subject Heading (MeSH) Categories for chlorotrianisene

US Patents and Regulatory Information for chlorotrianisene

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us TACE chlorotrianisene CAPSULE;ORAL 008102-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us TACE chlorotrianisene CAPSULE;ORAL 011444-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Banner Pharmacaps CHLOROTRIANISENE chlorotrianisene CAPSULE;ORAL 084652-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us TACE chlorotrianisene CAPSULE;ORAL 016235-001 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

Chlorotrianisene Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Chlorotrianisene

Introduction

Chlorotrianisene, a synthetic estrogen, has been used for several decades to treat symptoms of menopause and deficiencies in ovary function. Understanding the market dynamics and financial trajectory of this drug involves analyzing various factors, including production and sales data, competitive landscape, regulatory influences, and the broader pharmaceutical industry trends.

Historical Context and Usage

Chlorotrianisene was introduced in the mid-20th century as a treatment for menopausal symptoms, ovarian function deficiencies, and certain types of infertility. Its usage has been significant in the context of hormonal therapy, particularly before the widespread use of more modern estrogen therapies[4].

Production and Sales Trends

While specific production and sales data for chlorotrianisene are not readily available in recent reports, we can infer trends from the broader context of synthetic organic chemicals and pharmaceuticals.

  • Production of Synthetic Organic Chemicals: The production of synthetic organic chemicals, which includes chlorotrianisene, has seen fluctuations over the years. For instance, the total production of synthetic organic chemicals in the U.S. has generally increased, but with periodic declines due to market and regulatory factors[1].
  • Sales and Revenue: The sales value of synthetic organic chemicals, including pharmaceutical intermediates and finished products, has shown significant growth. However, the sales of specific drugs like chlorotrianisene may have declined as newer, more effective treatments have been developed and approved[1].

Competitive Landscape

The market for hormonal therapies, including estrogens like chlorotrianisene, is highly competitive.

  • Generic Competition: The entry of generic versions of drugs can significantly impact the market dynamics. Generic drug prices tend to fall as the number of competitors increases, with prices approaching long-run marginal costs when there are eight or more competitors[3].
  • Newer Therapies: The development and approval of newer hormonal therapies have likely reduced the market share of older drugs like chlorotrianisene. These newer therapies often offer improved efficacy and safety profiles, making them more attractive to both prescribers and patients.

Regulatory Influences

Regulatory changes can substantially affect the financial trajectory of pharmaceuticals.

  • FDA Approval and Scrutiny: Changes in FDA policies, such as increased scrutiny of generic drug applications, can impact the cost and timing of bringing generic versions of drugs to market. This can influence the number of firms entering the market and the resulting competition[3].
  • Patent Expirations: The expiration of patents for branded drugs allows generic versions to enter the market, which can lead to a significant reduction in prices and a shift in market share.

Financial Trajectory

The financial performance of chlorotrianisene is influenced by several key factors:

  • Revenue Decline: As newer therapies gain market share, the revenue from older drugs like chlorotrianisene is likely to decline. This decline can be accelerated by the entry of generic competitors.
  • Cost and Pricing: The cost of production and the pricing strategy of the drug can affect its profitability. Generic competition typically leads to lower prices, reducing the profit margins for the original branded drug[3].

Market Size and Growth

The overall market for menopausal treatments and hormonal therapies continues to grow, driven by demographic changes and increasing awareness of women's health issues.

  • Demographic Trends: An aging population and increased life expectancy contribute to a growing market for menopausal treatments.
  • Market Segmentation: The market is segmented into different types of hormonal therapies, with chlorotrianisene being one of the older options. Newer therapies, including bioidentical hormones and selective estrogen receptor modulators (SERMs), have gained popularity and market share[4].

Impact of Research and Development

Continuous research and development in the pharmaceutical industry drive innovation and the introduction of new treatments.

  • Innovative Therapies: Research into new therapeutic targets and mechanisms of action has led to the development of more targeted and effective treatments. For example, studies on the degradation of onco-proteins and the role of specific proteins in diseases have opened new avenues for therapeutic development[2].
  • Drug Repurposing: The repurposing of existing drugs, as seen in the case of niclosamide, can also impact the market by providing new treatment options and potentially reducing the demand for older drugs like chlorotrianisene[2].

Key Takeaways

  • Declining Market Share: Chlorotrianisene's market share has likely declined due to the introduction of newer, more effective hormonal therapies.
  • Generic Competition: The entry of generic versions of chlorotrianisene would further reduce its market share and pricing power.
  • Regulatory Influences: Changes in FDA policies and patent expirations significantly impact the market dynamics and financial trajectory of pharmaceuticals.
  • Research and Development: Continuous innovation in the pharmaceutical industry drives the development of new treatments, which can replace older drugs.

FAQs

What is chlorotrianisene used for?

Chlorotrianisene is used to treat symptoms of menopause, deficiencies in ovary function, including underdevelopment of female sexual characteristics, and some types of infertility[4].

How has the market for chlorotrianisene evolved over time?

The market for chlorotrianisene has evolved with the introduction of newer hormonal therapies, leading to a decline in its market share. Generic competition and regulatory changes have also impacted its financial trajectory.

What role do generic drugs play in the market for chlorotrianisene?

Generic versions of chlorotrianisene can significantly reduce its market share and pricing power, as generic drug prices tend to fall with increased competition[3].

How do regulatory changes affect the market for chlorotrianisene?

Regulatory changes, such as increased FDA scrutiny of generic drug applications and patent expirations, can influence the number of firms entering the market and the resulting competition, affecting the financial trajectory of chlorotrianisene[3].

What is the impact of research and development on the market for chlorotrianisene?

Continuous research and development in the pharmaceutical industry lead to the introduction of new and more effective treatments, which can replace older drugs like chlorotrianisene, further reducing its market share[2].

Sources

  1. U.S. International Trade Commission. SYNTHETIC ORGANIC CHEMICALS United States Production and Sales of Synthetic Organic Chemicals.
  2. University College London. Degradation of onco-proteins and oncogenic mediator proteins as a therapeutic route to treat acute leukaemia.
  3. Federal Trade Commission. Generic Drug Industry Dynamics.
  4. DrugBank. Chlorotrianisene: Uses, Interactions, Mechanism of Action.

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