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Last Updated: December 23, 2024

Isopropamide iodide - Generic Drug Details


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

Isopropamide iodide is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for isopropamide iodide.

Summary for isopropamide iodide

US Patents and Regulatory Information for isopropamide iodide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline DARBID isopropamide iodide TABLET;ORAL 010744-001 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

Isopropamide iodide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Isopropamide Iodide

Introduction to Isopropamide Iodide

Isopropamide iodide is a long-acting quaternary anticholinergic drug, primarily used in the treatment of peptic ulcers and other gastrointestinal disorders characterized by hyperacidity and hypermotility[1].

Therapeutic Use and Market Niche

Isopropamide iodide is specifically designed to reduce gastric acid secretion and motility, making it a valuable treatment option for patients suffering from peptic ulcers and other gastrointestinal issues. This niche market is critical, especially in regions with high prevalence rates of these conditions.

Competitive Landscape

The market for anticholinergic drugs, including isopropamide iodide, is influenced by several factors:

  • Generic Competition: The entry of generic versions of anticholinergic drugs can significantly impact the market dynamics. Generic drug prices tend to fall as the number of competitors increases, but they often remain above long-run marginal costs until there are eight or more competitors[4].
  • Branded vs. Generic: Branded drugs like isopropamide iodide may face competition from generic alternatives, which can erode market share and revenue over time.
  • Regulatory Environment: Changes in regulatory policies, such as those affecting FDA approvals and patent expirations, can influence the competitive landscape and pricing strategies.

Financial Trajectory

Revenue and Market Size

The financial trajectory of isopropamide iodide is tied to the broader gastrointestinal drug market. While specific revenue figures for isopropamide iodide are not readily available, the overall market for gastrointestinal treatments is substantial.

  • Gastrointestinal Drug Market: The market for gastrointestinal drugs is significant, driven by the prevalence of gastrointestinal disorders. However, the exact revenue share of isopropamide iodide within this market would depend on its market penetration and competition.

Pricing Dynamics

  • Generic Entry: As generic versions of isopropamide iodide enter the market, prices are likely to decline. Studies have shown that generic drug prices fall with the number of competitors, approaching long-run marginal costs when there are eight or more competitors[4].
  • Market Rents: The expected market size and rents play a crucial role in determining the number of firms that will enter the market. Higher expected rents attract more firms, leading to increased competition and lower prices[4].

Production and Supply Chain

Manufacturing and Distribution

Isopropamide iodide is manufactured by several pharmaceutical companies, including those with a strong presence in the gastrointestinal drug market. The production process involves synthesizing the drug according to its chemical formula and ensuring compliance with regulatory standards.

  • Raw Materials: The cost and availability of raw materials, such as iodine, can impact the production costs of isopropamide iodide. The global iodine market, for instance, has seen significant price surges in recent years, which could affect the production costs of iodine-based drugs[3].

Supply Chain Resilience

The supply chain for isopropamide iodide must be resilient to ensure consistent availability. Disruptions in the supply chain, such as those caused by raw material shortages or manufacturing issues, can impact the financial trajectory of the drug.

Regulatory and Legal Considerations

FDA Approvals and Compliance

Isopropamide iodide must comply with FDA regulations and guidelines. Any changes in regulatory policies or compliance issues can affect the drug's market presence and financial performance.

  • Litigation and Settlements: Pharmaceutical companies, including those producing isopropamide iodide, can face legal challenges and settlements that impact their financial health. For example, Janssen Pharmaceuticals, a major player in the pharmaceutical industry, has faced significant legal challenges and settlements in the past[2].

Market Trends and Forecast

Growth Drivers

  • Increasing Prevalence of Gastrointestinal Disorders: The growing prevalence of gastrointestinal disorders is expected to drive demand for treatments like isopropamide iodide.
  • Aging Population: An aging population is more likely to suffer from gastrointestinal issues, further increasing demand.

Challenges

  • Generic Competition: The entry of generic versions can reduce market share and revenue.
  • Regulatory Changes: Changes in regulatory policies can impact the drug's market position and pricing.

Regional Market Analysis

North America and Europe

  • These regions have a well-established market for gastrointestinal treatments. The demand for isopropamide iodide in these regions is influenced by the presence of strong healthcare systems and high awareness of gastrointestinal disorders.
  • Germany and the U.S.: These countries have seen significant growth in the demand for medical imaging devices and pharmaceuticals, which can indirectly influence the market for isopropamide iodide[3].

Asia Pacific

  • The Asia Pacific region, particularly countries like China and India, is expected to drive growth due to increasing emphasis on domestic pharmaceutical industries and agriculture. The "Make In India" policy, for example, is anticipated to boost the production of medical imaging devices and chemicals, including those related to isopropamide iodide[3].

Key Players and Market Strategies

Manufacturers and Distributors

Companies involved in the production and distribution of isopropamide iodide must adopt competitive strategies to maintain market share. This includes investing in research and development, expanding manufacturing capacities, and enhancing customer service.

  • Janssen Pharmaceuticals: Although not specifically mentioned as a producer of isopropamide iodide, Janssen Pharmaceuticals' strategies in the broader pharmaceutical market can provide insights into competitive tactics. For instance, Janssen's collaborations with other companies and investments in new technologies can be seen as strategies to maintain market dominance[2].

Conclusion

The market dynamics and financial trajectory of isopropamide iodide are influenced by a combination of factors including generic competition, regulatory environment, production costs, and regional market trends. Understanding these dynamics is crucial for pharmaceutical companies to develop effective market strategies and maintain a competitive edge.

Key Takeaways

  • Generic Competition: The entry of generic versions significantly impacts pricing and market share.
  • Regulatory Environment: Changes in regulatory policies can affect the drug's market position and pricing.
  • Production Costs: The cost and availability of raw materials, such as iodine, can impact production costs.
  • Regional Market Trends: Different regions have varying demand drivers and challenges.
  • Competitive Strategies: Companies must invest in R&D, expand manufacturing capacities, and enhance customer service to maintain market share.

Frequently Asked Questions

1. What is isopropamide iodide used for?

Isopropamide iodide is used in the treatment of peptic ulcers and other gastrointestinal disorders marked by hyperacidity and hypermotility[1].

2. How does generic competition affect the market for isopropamide iodide?

Generic competition can significantly reduce the market share and revenue of branded drugs like isopropamide iodide, as generic prices fall with the number of competitors[4].

3. What are the key drivers of the market for isopropamide iodide?

The market is driven by the increasing prevalence of gastrointestinal disorders, an aging population, and regional healthcare trends[3].

4. How do changes in regulatory policies impact the market for isopropamide iodide?

Changes in regulatory policies can affect the drug's market position, pricing, and the number of competitors entering the market[4].

5. What role does the supply chain play in the financial trajectory of isopropamide iodide?

A resilient supply chain is crucial to ensure consistent availability and to mitigate the impact of raw material shortages or manufacturing issues on the drug's financial performance.

Cited Sources

  1. DrugBank Online: Isopropamide iodide | DrugBank Online
  2. Wikipedia: Janssen Pharmaceuticals - Wikipedia
  3. Grand View Research: Iodine Market Size, Share, Growth & Trends Report, 2030
  4. Federal Trade Commission: Generic Drug Industry Dynamics - Federal Trade Commission

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