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Last Updated: December 22, 2024

DIGOXIN Drug Patent Profile


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When do Digoxin patents expire, and what generic alternatives are available?

Digoxin is a drug marketed by Amici Pharma, Hikma, Vistapharm Llc, Abraxis Pharm, Hospira, Sandoz, Wyeth Ayerst, Aurobindo Pharma Ltd, Hikma Intl Pharms, Impax Labs, Novitium Pharma, Rising, Stevens J, and Sun Pharm Inds Inc. and is included in seventeen NDAs.

The generic ingredient in DIGOXIN is digoxin. There are ten drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the digoxin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Digoxin

A generic version of DIGOXIN was approved as digoxin by RISING on December 23rd, 1999.

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Drug patent expirations by year for DIGOXIN
Drug Prices for DIGOXIN

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Drug Sales Revenue Trends for DIGOXIN

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Recent Clinical Trials for DIGOXIN

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SponsorPhase
State University of New York - Downstate Medical CenterPhase 1/Phase 2
Jacobio Pharmaceuticals Co., Ltd.Phase 1
Loxo Oncology, Inc.Phase 1

See all DIGOXIN clinical trials

Pharmacology for DIGOXIN
Drug ClassCardiac Glycoside
Medical Subject Heading (MeSH) Categories for DIGOXIN
Anatomical Therapeutic Chemical (ATC) Classes for DIGOXIN

US Patents and Regulatory Information for DIGOXIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amici Pharma DIGOXIN digoxin ELIXIR;ORAL 215209-001 Mar 11, 2022 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novitium Pharma DIGOXIN digoxin TABLET;ORAL 215307-001 Nov 22, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Inc DIGOXIN digoxin TABLET;ORAL 076363-001 Jan 31, 2003 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira DIGOXIN digoxin INJECTABLE;INJECTION 040206-001 Aug 28, 1998 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

DIGOXIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Digoxin

Introduction

Digoxin, a cardiac glycoside, is a crucial medication used to treat various heart conditions, including atrial fibrillation, atrial flutter, and heart failure. The market dynamics and financial trajectory of digoxin are influenced by several key factors, which are essential for understanding its current and future market position.

Global 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].

Market Drivers

Several factors drive the growth of the digoxin market:

Increasing Prevalence of Cardiovascular Diseases

The rising number of heart failure cases globally is a significant driver. Cardiovascular diseases are becoming more prevalent due to factors such as obesity, binge eating, lack of regular exercise, and increasing stress levels[1][3].

Aging Global Population

An aging population increases the demand for digoxin, as older individuals are more likely to suffer from heart conditions. This demographic shift is particularly significant in both high-income regions and emerging economies[3].

Government Initiatives and Policies

Government initiatives and policies aimed at managing cardiovascular diseases also boost the demand for digoxin. These policies often include programs for early diagnosis and treatment, which can increase the market accessibility of digoxin[3].

Personalized Medicine

The increasing focus on personalized medicine could enhance the tailored use of digoxin oral solutions, offering potential for market growth. This includes leveraging digital health technologies to improve precision in dosing and patient monitoring[3].

Market Segments

The digoxin market is segmented based on type and application:

Segment by Type

  • Purity Above 98%: This segment is crucial for ensuring the high quality and efficacy of digoxin.
  • Purity Below 98%: While less pure, this segment still has its applications, particularly in regions where stringent quality standards may not be as rigid[1].

Segment by Application

  • Tablet Product: Digoxin tablets are widely used due to their ease of administration.
  • Injection Product: Digoxin injections are used in more severe cases or where rapid action is required[1].

Key Players

The market is competitive, with several key players:

C2 Pharma

C2 Pharma has taken significant steps to secure the supply chain by acquiring the Digoxin API portfolio from Nobilus Ent, ensuring a stable supply of high-quality digoxin[5].

Alkaloids Corporation

Known for its expertise in producing high-purity APIs, Alkaloids Corporation is a major player in the digoxin market.

Vital Labs

Vital Labs is another key player, focusing on the development and manufacturing of digoxin products.

Alchem

Alchem also plays a significant role in the market, contributing to the overall supply and innovation in digoxin products[1].

Financial Trajectory

The financial performance of the digoxin market is influenced by several factors:

Revenue Growth

The market is expected to grow from USD 60 million in 2021 to USD 74 million by 2030, indicating a steady revenue growth trajectory[1][4].

Research and Development Expenses

Companies like Lexicon Pharmaceuticals, although not directly involved in digoxin, illustrate the importance of R&D expenses in the pharmaceutical sector. For digoxin, R&D expenses are crucial for developing improved formulations and addressing side effects[2].

Competitive Landscape

The competitive landscape is highly dynamic, with companies focusing on product differentiation, improved efficacy, and strategic collaborations to drive market share. This competition drives innovation and better patient outcomes[3].

Market Challenges

Despite the growth drivers, the digoxin market faces several challenges:

Regulatory Hurdles

Stringent regulatory landscapes and the complexity of clinical trials and approval processes can hinder the development and launch of new digoxin products[3].

Side Effects and Patient Safety

Adverse medication side effects and patient safety concerns are significant constraints. Ensuring the safety and efficacy of digoxin is a continuous challenge for manufacturers[3].

Dosage Standardization

Difficulty in standardizing dosages and precise administration complicates the market growth. Innovations in delivery systems, such as extended-release formulations, are needed to address these issues[3].

Market Opportunities

There are several opportunities for growth in the digoxin market:

Alternative Delivery Systems

Developing alternative delivery systems, such as extended-release formulations, can enhance patient compliance and outcomes.

Digital Health Technologies

Leveraging AI and machine learning in drug development and patient monitoring can improve precision and efficacy.

Collaborations with Healthcare Providers

Collaborating with cardiac rehabilitation centers and healthcare providers can strengthen brand visibility and product acceptance[3].

Key Takeaways

  • The global digoxin market is projected to grow from USD 60 million in 2021 to USD 74 million by 2030.
  • Key drivers include the increasing prevalence of cardiovascular diseases, an aging population, and government initiatives.
  • The market is segmented by type and application, with purity above 98% and tablet products being significant segments.
  • Key players include C2 Pharma, Alkaloids Corporation, Vital Labs, and Alchem.
  • Challenges include regulatory hurdles, side effects, and dosage standardization issues.
  • Opportunities for growth include developing alternative delivery systems, leveraging digital health technologies, and collaborating with healthcare providers.

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].

What is the CAGR of the digoxin market from 2022 to 2030?

The digoxin market is expected to exhibit a CAGR of 3.1% during the forecast period[1][4].

What are the main drivers of the digoxin market?

The main drivers include the increasing prevalence of cardiovascular diseases, an aging global population, and government initiatives aimed at managing cardiovascular diseases[1][3].

Who are the key players in the digoxin market?

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

What are the major challenges facing the digoxin market?

Major challenges include regulatory hurdles, adverse medication side effects, and difficulties in dosage standardization[3].

Sources

  1. Biospace: Digoxin Market Size, Trends, Growth, Forecast Report 2022-2030
  2. Biospace: Lexicon Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Business Update
  3. 360iResearch: Digoxin Oral Solution Market Size & Share 2025-2030
  4. Business Research Insights: Digoxin Market Size, Forecast - 2031 Report
  5. Manufacturing Chemist: C2 Pharma acquires Digoxin API portfolio to secure supply chain

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