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Last Updated: December 23, 2024

TRIDIHEXETHYL CHLORIDE - Generic Drug Details


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

Tridihexethyl chloride is the generic ingredient in one branded drug marketed by Lederle and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for TRIDIHEXETHYL CHLORIDE
US Patents:0
Tradenames:1
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 23
Patent Applications: 1,274
DailyMed Link:TRIDIHEXETHYL CHLORIDE at DailyMed

US Patents and Regulatory Information for TRIDIHEXETHYL CHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lederle PATHILON tridihexethyl chloride TABLET;ORAL 009489-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lederle PATHILON tridihexethyl chloride INJECTABLE;INJECTION 009729-001 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

TRIDIHEXETHYL CHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tridihexethyl Chloride

Introduction

Tridihexethyl chloride, marketed under the brand name Pathilon, was a synthetic anticholinergic agent used primarily as an adjunct in the treatment of peptic ulcer disease. Here, we will delve into the market dynamics and financial trajectory of this drug, highlighting its rise, challenges, and eventual withdrawal from the market.

Historical Context

Tridihexethyl chloride was introduced in the mid-20th century as a treatment for peptic ulcer disease. During its peak, it was part of a broader class of anticholinergic agents that were popular for their ability to reduce gastric acid secretion by antagonizing the action of acetylcholine[4].

Market Demand and Usage

In the 1960s and 1970s, there was a significant demand for treatments targeting peptic ulcer disease. Tridihexethyl chloride filled this need by providing a pharmacological solution that could reduce the symptoms of ulcers. It was prescribed in doses of 25-50 mg, taken three to four times a day[5].

Financial Performance

The financial performance of tridihexethyl chloride was tied to the overall market for anticholinergic agents and gastrointestinal treatments. During its active years, the drug contributed to the revenue streams of pharmaceutical companies specializing in synthetic organic chemicals. However, specific financial data on tridihexethyl chloride is not readily available, as it was part of a larger category of synthetic organic chemicals that included various other products[1].

Competitive Landscape

The market for peptic ulcer treatments was competitive, with several other anticholinergic agents and later, more advanced treatments like H2 receptor antagonists and proton pump inhibitors. Tridihexethyl chloride faced competition from other drugs that offered similar or better efficacy and safety profiles.

Regulatory Environment

The regulatory environment played a crucial role in the market dynamics of tridihexethyl chloride. Drugs like tridihexethyl chloride were subject to stringent regulations, including those related to safety, efficacy, and side effects. Any adverse findings or regulatory changes could significantly impact the drug's market position[2].

Safety and Efficacy Concerns

Tridihexethyl chloride, like other anticholinergic agents, had a profile of side effects that included CNS activity, dry mouth, and other anticholinergic symptoms. These side effects, along with the emergence of more effective and safer treatments, contributed to its declining use. Additionally, the drug was examined for its effect on patients with acquired nystagmus, but its use in this area was limited due to its side effect profile[4].

Decline and Withdrawal

As newer and more effective treatments for peptic ulcer disease emerged, the demand for tridihexethyl chloride decreased. The drug is no longer available in the US market, reflecting its decline in clinical use and the shift towards more modern therapeutic options.

Impact on Pharmaceutical Companies

The withdrawal of tridihexethyl chloride from the market had financial implications for the pharmaceutical companies that produced it. These companies had to adapt by focusing on other products or developing new treatments to replace the revenue lost from tridihexethyl chloride.

Key Takeaways

  • Market Demand: Tridihexethyl chloride was popular in the mid-20th century for treating peptic ulcer disease.
  • Financial Performance: The drug contributed to the revenue of pharmaceutical companies but lacked specific financial data due to being part of a broader category.
  • Competitive Landscape: Faced competition from other anticholinergic agents and later, more advanced treatments.
  • Regulatory Environment: Subject to stringent regulations that impacted its market position.
  • Safety and Efficacy Concerns: Side effects and the emergence of safer treatments led to its decline.
  • Decline and Withdrawal: No longer available in the US market due to decreased demand and better therapeutic options.

FAQs

  1. What was tridihexethyl chloride used for? Tridihexethyl chloride was used as an adjunct in the treatment of peptic ulcer disease.

  2. Why was tridihexethyl chloride withdrawn from the market? It was withdrawn due to the emergence of more effective and safer treatments for peptic ulcer disease, along with its side effect profile.

  3. What were the common side effects of tridihexethyl chloride? Common side effects included CNS activity, dry mouth, and other anticholinergic symptoms.

  4. Is tridihexethyl chloride still available in the US market? No, tridihexethyl chloride is no longer available in the US market.

  5. What replaced tridihexethyl chloride in the treatment of peptic ulcer disease? It was replaced by more advanced treatments such as H2 receptor antagonists and proton pump inhibitors.

Sources

  1. USITC Report on Synthetic Organic Chemicals - This report provides data on the production and sales of various synthetic organic chemicals, including those related to tridihexethyl chloride[1].
  2. GovInfo - Proposed Rules and Regulations - This document outlines various regulatory changes and proposals that could impact pharmaceuticals like tridihexethyl chloride[2].
  3. Pierce County Medical Society Bulletin - Although not directly related, this bulletin provides context on medical practices and drug usage during the relevant period[3].
  4. Inxight Drugs - Tridihexethyl Chloride - This source provides detailed pharmacological information on tridihexethyl chloride[4].
  5. Katzung Pharmacology - This pharmacology textbook includes information on the dosage and usage of tridihexethyl chloride[5].

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