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Last Updated: December 22, 2024

Digitoxin - Generic Drug Details


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What are the generic drug sources for digitoxin and what is the scope of patent protection?

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

Summary for digitoxin
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 71
Clinical Trials: 2
Patent Applications: 6,596
DailyMed Link:digitoxin at DailyMed
Recent Clinical Trials for digitoxin

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

SponsorPhase
University of Texas Southwestern Medical CenterPhase 1
Pamela L. Zeitlin, MD, PhDPhase 2
National Jewish HealthPhase 2

See all digitoxin clinical trials

Medical Subject Heading (MeSH) Categories for digitoxin
Anatomical Therapeutic Chemical (ATC) Classes for digitoxin

US Patents and Regulatory Information for digitoxin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly CRYSTODIGIN digitoxin INJECTABLE;INJECTION 084100-005 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

Digitoxin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Digoxin: A Comprehensive Analysis

Introduction to Digoxin

Digoxin, a cardiac glycoside derived from the foxglove plant, has been a cornerstone in the treatment of heart failure and atrial fibrillation for over two centuries. Despite its long history, the market dynamics and financial trajectory of digoxin are influenced by various factors, including advancements in medical treatments, regulatory environments, and patient outcomes.

Current Market Size and Forecast

The global digoxin market was valued at approximately USD 60 million in 2021. It is projected to grow to USD 74 million by 2030, with a Compound Annual Growth Rate (CAGR) of 3.1% during the forecast period of 2022-2030[1][4].

Key Players in the Digoxin Market

The digoxin market is characterized by a competitive landscape with several key players. These include C2 Pharma, Alkaloids Corporation, Vital Labs, and Alchem. These companies employ various strategies to maintain their market positions, including product diversification, strategic partnerships, and continuous innovation[1].

Driving Factors of the Digoxin Market

Several factors drive the growth of the digoxin market:

  • Increasing Prevalence of Heart Failure: The rising incidence of heart failure globally is a significant driver. As the population ages and cardiovascular diseases become more prevalent, the demand for digoxin is expected to increase[4].
  • Expanding Reliability: Despite the advent of newer treatments, digoxin remains a reliable option for certain patient subgroups, particularly those with higher-risk profiles[2].

Challenges and Limitations

Decreasing Prescriptions

The use of digoxin has been declining over the past few decades due to the introduction of newer, more effective treatments for heart failure. For instance, prescriptions for digoxin in the United States dropped by 46.4% from 2007 to 2014, and office visits for digoxin therapy declined by 91% from 1997 to 2012[3].

Toxicity and Safety Concerns

Digoxin has a narrow therapeutic index, which means the difference between a therapeutic dose and a toxic dose is small. This leads to frequent cases of digoxin toxicity, which can result in significant healthcare costs. The mean overall cost associated with digoxin toxicity was found to be approximately $4,087.05, with a significant correlation between the total cost and the serum digoxin concentration on admission[5].

Economic Impact

The economic value of digoxin therapy is complex. While it can reduce hospitalizations and associated costs in certain patient subgroups, it is not universally cost-saving. For example, digoxin therapy was cost-saving in only 27% of bootstrap samples using Medicare costs and in 44% of samples using commercial carrier costs[2].

Regional Market Dynamics

The digoxin market varies significantly across different regions due to differences in healthcare systems, regulatory environments, and patient demographics. The market analysis includes detailed insights into the demand and supply dynamics in various regions, which have a major influence on the market's expansion[1].

Competitive Landscape

The competitive landscape of the digoxin market is intense, with multiple players vying for market share. The report provides a comprehensive analysis of the strategies employed by key players, including their product offerings, recent developments, and financial information. This competitive outlook is crucial for understanding the market dynamics and identifying opportunities for growth[1].

Market Segmentation

The digoxin market can be segmented based on application, region, and other factors. The segmentation analysis provides quantitative and qualitative research, discussing the influence of policy-based and economic aspects on the market. This segmentation helps in understanding the specific needs of different market segments and tailoring strategies accordingly[1].

Future Outlook

Despite the challenges, digoxin remains a valuable treatment option for certain patient groups. The future outlook for the digoxin market is modest but stable, driven by the ongoing need for effective treatments for heart failure and atrial fibrillation.

Emerging Trends

  • Personalized Medicine: There is a growing trend towards personalized medicine, where treatments are tailored to individual patient needs. This could see a resurgence in the use of digoxin for specific patient subgroups where it is most effective.
  • Combination Therapies: The use of digoxin in combination with other medications could offer new avenues for treatment, potentially increasing its market value.

Regulatory Environment

The regulatory environment plays a crucial role in shaping the digoxin market. Changes in regulations, such as those related to drug safety and efficacy, can significantly impact the market dynamics. Ensuring compliance with regulatory requirements is essential for market players to maintain their market positions[1].

Patient Outcomes and Cost-Effectiveness

The use of digoxin is associated with reduced hospitalizations, particularly in higher-risk patient subgroups. However, its cost-effectiveness varies. In some cases, the cost savings from reduced hospitalizations can offset the costs of the therapy, making it a viable option for certain patients[2].

Conclusion

The digoxin market, while facing challenges from newer treatments and safety concerns, remains a significant segment in the pharmaceutical industry. Understanding the market dynamics, including the driving factors, competitive landscape, and regional variations, is crucial for business professionals looking to navigate this market.

Key Takeaways

  • The global digoxin market is projected to grow to USD 74 million by 2030 with a CAGR of 3.1%.
  • Key players include C2 Pharma, Alkaloids Corporation, Vital Labs, and Alchem.
  • The market is driven by the increasing prevalence of heart failure and the expanding reliability of digoxin.
  • Safety concerns and toxicity issues are significant challenges.
  • The economic value of digoxin therapy varies, with cost savings observed in certain patient subgroups.

FAQs

What is the projected market size of digoxin by 2030?

The global digoxin market is forecast to reach USD 74 million by 2030[1][4].

Who are the key players in the digoxin market?

Key players include C2 Pharma, Alkaloids Corporation, Vital Labs, and Alchem[1].

What are the driving factors of the digoxin market?

The market is driven by the increasing prevalence of heart failure and the expanding reliability of digoxin[4].

What are the safety concerns associated with digoxin?

Digoxin has a narrow therapeutic index, leading to frequent cases of toxicity, which can result in significant healthcare costs[3][5].

How does the regulatory environment impact the digoxin market?

Changes in regulations related to drug safety and efficacy can significantly impact the market dynamics, and ensuring compliance is essential for market players[1].

Sources

  1. Biospace: Digoxin Market Size, Trends, Growth, Forecast Report 2022-2030.
  2. PubMed: What is the economic value of digoxin therapy in congestive heart failure?
  3. CCJM: Digoxin is still useful, but is still causing toxicity.
  4. Business Research Insights: Digoxin Market Size, Forecast - 2031 Report.
  5. PubMed: Economic impact of digoxin toxicity.

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