Digoxin - Generic Drug Details

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

Digoxin is the generic ingredient in five branded drugs marketed by Glaxosmithkline Llc, Amici Pharma, Hikma, Vistapharm Llc, Abraxis Pharm, Hospira, Sandoz, Wyeth Ayerst, Covis, Aurobindo Pharma Ltd, Hikma Intl Pharms, Impax Labs, Novitium Pharma, Rising, Stevens J, Sun Pharm Inds Inc, and Concordia, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for digoxin. Thirty suppliers are listed for this compound.

Summary for digoxin

US Patents:	0
Tradenames:	5
Applicants:	17
NDAs:	20
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	233
Patent Applications:	6,197
Drug Prices:	Drug price trends for digoxin
Drug Sales Revenues:	Drug sales revenues for digoxin
What excipients (inactive ingredients) are in digoxin?	digoxin excipients list
DailyMed Link:	digoxin at DailyMed

See drug prices for digoxin

See drug sales revenues for digoxin

Recent Clinical Trials for digoxin

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

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

See all digoxin clinical trials

Pharmacology for digoxin

Drug Class

Cardiac Glycoside

Medical Subject Heading (MeSH) Categories for digoxin

Anti-Arrhythmia Agents

Cardiotonic Agents

Enzyme Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for digoxin

C01AA	Digitalis glycosides
C01A	CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

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
Hikma Intl Pharms	DIGOXIN	digoxin	TABLET;ORAL	077002-001	Oct 30, 2007	AB	RX	No	No
Hikma Intl Pharms	DIGOXIN	digoxin	TABLET;ORAL	077002-002	Oct 30, 2007	AB	RX	No	No
Aurobindo Pharma Ltd	DIGOXIN	digoxin	TABLET;ORAL	214982-003	Feb 8, 2022	AB	RX	No	No
Aurobindo Pharma Ltd	DIGOXIN	digoxin	TABLET;ORAL	214982-002	Feb 8, 2022	AB	RX	No	No
Stevens J	DIGOXIN	digoxin	TABLET;ORAL	076268-002	Jul 26, 2002	AB	RX	No	No

Expired US Patents for digoxin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-002	Jul 26, 1982	4,088,750
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-001	Jul 26, 1982	4,088,750
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-003	Jul 26, 1982	4,088,750
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-004	Sep 24, 1984	4,088,750

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