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Last Updated: December 24, 2024

LANOXIN Drug Patent Profile


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Which patents cover Lanoxin, and when can generic versions of Lanoxin launch?

Lanoxin is a drug marketed by Covis and Concordia and is included in two NDAs.

The generic ingredient in LANOXIN 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 Lanoxin

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

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Summary for LANOXIN
Drug patent expirations by year for LANOXIN
Drug Prices for LANOXIN

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Drug Sales Revenue Trends for LANOXIN

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Recent Clinical Trials for LANOXIN

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

SponsorPhase
Turning Point Therapeutics, Inc.Phase 1
Yale UniversityPhase 2
Jean Grem, MDPhase 2

See all LANOXIN clinical trials

Pharmacology for LANOXIN
Drug ClassCardiac Glycoside

US Patents and Regulatory Information for LANOXIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Covis LANOXIN digoxin INJECTABLE;INJECTION 009330-002 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Concordia LANOXIN digoxin TABLET;ORAL 020405-006 Sep 30, 1997 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Concordia LANOXIN digoxin TABLET;ORAL 020405-003 Sep 30, 1997 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Covis LANOXIN PEDIATRIC digoxin INJECTABLE;INJECTION 009330-004 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Concordia LANOXIN digoxin TABLET;ORAL 020405-001 Sep 30, 1997 AB RX Yes 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

LANOXIN Market Analysis and Financial Projection Experimental

LANOXIN: Understanding Market Dynamics and Financial Trajectory

Overview of LANOXIN

LANOXIN, also known as digoxin, is a heart medication used to treat mild to moderate heart failure and abnormal heart rhythms, particularly in conditions like atrial fibrillation. It is a positive inotropic and negative chronotropic drug, meaning it increases the force of the heartbeat and decreases the heart rate[4].

Global Digoxin Market Size and Forecast

The global digoxin market, which includes LANOXIN, has been growing steadily. As of 2021, the market size was valued at USD 60 million. It is projected to reach USD 81.1 million by 2031, exhibiting a Compound Annual Growth Rate (CAGR) of 3.1% during the forecast period[1].

Driving Factors

Several factors are driving the growth of the digoxin market:

Increasing Prevalence of Heart Failure

The rise in the rate of heart failures globally is a significant driver. Heart failure is a chronic condition that requires ongoing management, and digoxin is often prescribed to manage symptoms and improve quality of life[1].

Expanding Reliability

The reliability of digoxin in treating heart conditions has been well-established through clinical studies. This reliability contributes to its continued use and recommendation by healthcare professionals[4].

Growing Demand in Emerging Markets

Emerging markets, particularly in Asia-Pacific and Latin America, are seeing an increase in demand for heart medications due to growing populations and improving healthcare infrastructure[3].

Market Growth Determinants and Changing Dynamics

Growth Drivers

  • Clinical Efficacy: Digoxin has demonstrated effectiveness in increasing exercise capacity and reducing hospitalizations due to heart failure[4].
  • Regulatory Approvals: The drug is approved in many regions, including the US, which ensures a stable market presence[4].

Available Opportunities

  • Untapped Markets: There are opportunities for expansion in regions where access to heart medications is limited.
  • Combination Therapies: Research into combination therapies involving digoxin could open new avenues for treatment[3].

Influencing Trends

  • Advancements in Healthcare: Improvements in healthcare technology and diagnostics are leading to better detection and management of heart conditions.
  • Aging Population: The global aging population is increasing the demand for heart medications like digoxin[3].

Restraint & Challenges

  • Narrow Therapeutic Window: Digoxin has a narrow therapeutic window, which means the difference between a therapeutic dose and a toxic dose is small. This requires careful monitoring and can limit its use in some patients[4].
  • Side Effects and Toxicity: The risk of digoxin toxicity, which can manifest as nausea, vomiting, visual changes, and arrhythmias, is a significant challenge[4].

Regional Dynamics

North America

  • The North American market is one of the largest for digoxin, driven by high healthcare spending and advanced medical infrastructure[3].

Europe

  • Europe also represents a significant market, with countries like Germany, France, and the UK contributing substantially to the regional demand[3].

Asia Pacific

  • The Asia Pacific region is expected to grow rapidly due to increasing healthcare expenditure and a large patient population[3].

Competitive Landscape

Key Players

  • The digoxin market is dominated by several key players, including Daewon, Kostat, Sunris, Peak International, and others. These companies are involved in the manufacturing and distribution of digoxin products globally[1].

Market Concentration

  • The market concentration ratio indicates that the market is moderately competitive, with a few major players holding significant market share[3].

Financial Performance of Key Players

While the financial performance of companies specifically producing LANOXIN is not detailed in the sources, the overall market trends suggest stable revenue growth. Here are some general insights:

Revenue Growth

  • The global digoxin market is expected to grow from USD 60 million in 2021 to USD 81.1 million by 2031, indicating a steady increase in revenue for companies involved in this market[1].

Profitability

  • The profitability of these companies can be influenced by factors such as production costs, regulatory environments, and market competition. Efficient manufacturing and distribution strategies are crucial for maintaining profitability[3].

Government Policies and Regulatory Factors

Approval and Compliance

  • Digoxin is approved in many countries, and compliance with regulatory standards is essential for market presence. Companies must adhere to strict guidelines to ensure the safety and efficacy of their products[4].

Pricing Regulations

  • Government policies on drug pricing can impact the revenue of companies producing digoxin. In some regions, price controls may limit the profit margins of pharmaceutical companies[3].

Value Chain Analysis

Manufacturing

  • The manufacturing process involves strict quality control measures to ensure the drug meets therapeutic standards. Companies invest heavily in research and development to improve manufacturing processes[3].

Distribution

  • Effective distribution networks are critical for ensuring that the drug reaches healthcare providers and patients promptly. Companies often partner with distributors to expand their reach[3].

Impact of Macro-Economic Factors

Economic Growth

  • Economic growth in various regions can increase healthcare spending, which in turn can boost the demand for heart medications like digoxin[3].

Inflation

  • Inflation can affect the production costs and pricing of digoxin, impacting the profitability of companies involved in its production and distribution[3].

Market Entry Strategies

Partnerships and Collaborations

  • New entrants often form partnerships with established players to gain market access and leverage existing distribution networks[3].

Innovation

  • Innovations in drug delivery systems or combination therapies can provide a competitive edge for new entrants in the market[3].

Key Takeaways

  • The global digoxin market is projected to grow to USD 81.1 million by 2031.
  • The market is driven by the increasing prevalence of heart failure and the reliability of digoxin in treatment.
  • Regional dynamics vary, with North America and Europe being significant markets.
  • The competitive landscape is moderately concentrated, with a few major players.
  • Regulatory compliance and efficient manufacturing are crucial for market success.

FAQs

What is the projected market size of the global digoxin market by 2031?

The global digoxin market is projected to touch USD 81.1 million by 2031[1].

What is the CAGR of the digoxin market from 2021 to 2031?

The digoxin market is expected to exhibit a CAGR of 3.1% from 2021 to 2031[1].

What are the primary uses of digoxin?

Digoxin is used to treat mild to moderate heart failure and abnormal heart rhythms, particularly in conditions like atrial fibrillation[4].

Who are the top companies operating in the digoxin market?

Top companies include Daewon, Kostat, Sunris, Peak International, and others[1].

What are the major challenges in the digoxin market?

The major challenges include the narrow therapeutic window of digoxin and the risk of toxicity, as well as regulatory and competitive pressures[4].

Sources

  1. Business Research Insights: Digoxin Market Size, Forecast - 2031 Report.
  2. Lantronix: Lantronix Reports Record Revenue for Fourth Quarter and Full Fiscal 2024.
  3. HTF Market Intelligence: Digoxin Market Analysis by Relevant Business Segment & Application.
  4. DrugBank: Digoxin: Uses, Interactions, Mechanism of Action.

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