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Last Updated: December 22, 2024

Chlorpropamide - Generic Drug Details


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

Chlorpropamide is the generic ingredient in three branded drugs marketed by Ani Pharms, Dava Pharms Inc, Halsey, Norvium Bioscience, Par Pharm, Rising, Sandoz, Superpharm, Usl Pharma, Watson Labs, Watson Labs Teva, and Pfizer, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for chlorpropamide.

Summary for chlorpropamide
Recent Clinical Trials for chlorpropamide

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

SponsorPhase
Canadian Network for Observational Drug Effect Studies, CNODES
Drug Safety and Effectiveness Network, Canada
Canadian Institutes of Health Research (CIHR)

See all chlorpropamide clinical trials

Medical Subject Heading (MeSH) Categories for chlorpropamide

US Patents and Regulatory Information for chlorpropamide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Halsey CHLORPROPAMIDE chlorpropamide TABLET;ORAL 089321-001 Jan 16, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dava Pharms Inc CHLORPROPAMIDE chlorpropamide TABLET;ORAL 089562-001 Sep 4, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms CHLORPROPAMIDE chlorpropamide TABLET;ORAL 088918-001 Oct 16, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rising CHLORPROPAMIDE chlorpropamide TABLET;ORAL 088725-001 Aug 31, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dava Pharms Inc CHLORPROPAMIDE chlorpropamide TABLET;ORAL 089561-001 Sep 4, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Usl Pharma CHLORPROPAMIDE chlorpropamide TABLET;ORAL 088708-001 Aug 30, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Norvium Bioscience CHLORPROPAMIDE chlorpropamide TABLET;ORAL 088549-001 Jun 1, 1984 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

Chlorpropamide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Chlorpropamide (Diabinese)

Introduction to Chlorpropamide

Chlorpropamide, known by the brand name Diabinese, is a sulfonylurea-class drug used to treat type 2 diabetes mellitus. It works by stimulating the pancreas to release insulin, thereby lowering blood glucose levels. Here, we will delve into the market dynamics and financial trajectory of chlorpropamide.

Market Trends and Growth Drivers

The demand for chlorpropamide is driven by several key factors:

Rising Prevalence of Type 2 Diabetes

The increasing prevalence of non-insulin-dependent diabetes mellitus (NIDDM) in developed countries is a significant driver for the chlorpropamide market. As the global population ages and lifestyles become more sedentary, the incidence of type 2 diabetes is expected to rise, thereby increasing the demand for antidiabetic medications like chlorpropamide[1][2].

Economic and Demographic Factors

The growing middle class in emerging economies and the increasing awareness of diabetes management contribute to the market growth. Additionally, government initiatives and healthcare policies aimed at improving diabetes care also boost the demand for chlorpropamide[1].

Consumer Insights

Patient Preferences and Compliance

Patients with type 2 diabetes often prefer oral medications over injectables, making chlorpropamide a popular choice. However, the risk of hypoglycemia and the need for consistent food intake to manage this risk can affect patient compliance. Educating patients about the proper use and benefits of chlorpropamide is crucial for maintaining market demand[2][4].

Procurement Insights

Raw Materials and Manufacturing Process

The manufacturing process of chlorpropamide involves the synthesis of the active pharmaceutical ingredient (API) through the reaction of 1-chloro-3-propylurea with p-chlorophenol. The raw materials required and the purification process are critical for ensuring the quality and efficacy of the final product. Understanding the procurement costs and optimizing the supply chain for these raw materials is essential for maintaining profitability[1].

Industry Stats and Market Analysis

Historical, Current, and Forecasted Price Trends

The market dynamics of chlorpropamide are influenced by historical, current, and forecasted price trends. The report by Expert Market Research provides detailed insights into price volatility, helping stakeholders understand market fluctuations and make informed decisions. The prices are affected by factors such as raw material costs, production capacities, and regulatory changes[1].

Capital Investment and Operating Costs

Setting up a chlorpropamide manufacturing plant requires significant capital investment, including costs for raw materials, utilities, labor, packaging, transportation, land acquisition, construction, and machinery. The operating costs, which include recurring expenses such as maintenance and utilities, also play a crucial role in determining the financial viability of the plant. A comprehensive analysis of these costs is necessary for stakeholders to assess the profitability of the venture[1].

Financial Performance and Profit Margins

Projected Profit Margins

The financial performance of chlorpropamide manufacturing is closely tied to the projected profit margins. The report outlines strategies for maximizing profitability, including optimal product pricing and cost optimization techniques. Understanding the market demand and competition is key to setting the right pricing strategies[1].

Regulatory Frameworks and Sustainability

Regulatory frameworks and sustainability measures are critical for the financial trajectory of chlorpropamide. Compliance with regulatory requirements and adherence to environmental and sustainability standards can impact production costs and market acceptance. The report addresses these aspects, providing guidance on navigating the regulatory landscape and implementing sustainable practices[1].

Competitive Analysis

Key Industry Players

The chlorpropamide market is characterized by the presence of several key industry players. These players are profiled in the report, providing insights into their market strategies, production capacities, and financial performance. This information is crucial for benchmarking and competitive analysis, helping new entrants and existing players to position themselves effectively in the market[1].

Mechanism of Action and Clinical Significance

How Chlorpropamide Works

Chlorpropamide binds to ATP-sensitive potassium channels on the pancreatic cell surface, reducing potassium conductance and causing depolarization of the membrane. This depolarization stimulates calcium ion influx, leading to the secretion of insulin. This mechanism is essential for understanding the clinical efficacy and potential side effects of the drug[2][4].

Long-Term Effects and Clinical Outcomes

Long-Term Impact on Insulin Secretion

Studies have shown that chlorpropamide increases insulin secretion over long periods, improving glucose tolerance in patients with type 2 diabetes. This long-term effect is beneficial for managing the disease but also requires careful monitoring to avoid hypoglycemia[3].

Market Challenges and Risks

Side Effects and Contraindications

Chlorpropamide is associated with several side effects, including hypoglycemia, weight gain, and increased risk of blood pressure and retinopathy. These risks necessitate careful patient selection and monitoring, which can impact market demand and financial performance[2][4].

Conclusion

The market dynamics and financial trajectory of chlorpropamide are influenced by a combination of factors including the rising prevalence of type 2 diabetes, economic and demographic trends, and the drug's mechanism of action and clinical outcomes. Understanding these elements is crucial for stakeholders to navigate the complexities of the market effectively.

Key Takeaways

  • Increasing Demand: The rising prevalence of type 2 diabetes drives the demand for chlorpropamide.
  • Manufacturing Costs: Significant capital investment and operating costs are involved in setting up and running a chlorpropamide manufacturing plant.
  • Regulatory Compliance: Adherence to regulatory frameworks and sustainability standards is essential.
  • Competitive Landscape: Benchmarking against key industry players is crucial for market positioning.
  • Clinical Efficacy: Chlorpropamide's mechanism of action and long-term effects on insulin secretion are vital for its clinical significance.
  • Risk Management: Managing side effects and contraindications is critical for patient safety and market sustainability.

FAQs

Q: What is the primary use of chlorpropamide?

A: Chlorpropamide is used to treat type 2 diabetes mellitus by stimulating the pancreas to release insulin, thereby lowering blood glucose levels.

Q: How does chlorpropamide work?

A: Chlorpropamide binds to ATP-sensitive potassium channels on the pancreatic cell surface, reducing potassium conductance and causing depolarization of the membrane, which stimulates calcium ion influx and insulin secretion.

Q: What are the common side effects of chlorpropamide?

A: Common side effects include hypoglycemia, weight gain, and increased risk of blood pressure and retinopathy.

Q: What is the impact of chlorpropamide on long-term insulin secretion?

A: Chlorpropamide has been shown to increase insulin secretion over long periods, improving glucose tolerance in patients with type 2 diabetes.

Q: What are the key factors driving the demand for chlorpropamide?

A: The rising prevalence of type 2 diabetes, economic and demographic trends, and the drug's clinical efficacy are key drivers of demand.

Sources

  1. Expert Market Research: "Global Chlorpropamide (Diabinese) Manufacturing Plant Project Report 2024 Edition: Industry Trends, Capital Investment, Price Trends, Manufacturing Process, Raw Materials Requirement, Plant Setup, Operating Cost, and Revenue Statistics."
  2. DrugBank: "Chlorpropamide: Uses, Interactions, Mechanism of Action."
  3. PubMed: "The long-term effects of chlorpropamide on insulin, C-peptide, and glucose tolerance in nonobese patients with non-insulin-dependent diabetes mellitus."
  4. FDA: "DIABINESE - (chlorpropamide) - accessdata.fda.gov."

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