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Last Updated: December 22, 2024

FLECAINIDE ACETATE Drug Patent Profile


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

Flecainide Acetate is a drug marketed by Amneal Pharm, Ani Pharms, Aurobindo Pharma Ltd, Beximco Pharms Usa, Chartwell, Hikma, Sun Pharm Inds Ltd, and Yichang Humanwell. and is included in nine NDAs.

The generic ingredient in FLECAINIDE ACETATE is flecainide acetate. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the flecainide acetate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Flecainide Acetate

A generic version of FLECAINIDE ACETATE was approved as flecainide acetate by AMNEAL PHARM on July 31st, 2001.

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Drug patent expirations by year for FLECAINIDE ACETATE
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Recent Clinical Trials for FLECAINIDE ACETATE

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SponsorPhase
InCarda Therapeutics, Inc.Phase 3
InCarda Therapeutics Australia Pty Ltd.Phase 2
InCarda Therapeutics, Inc.Phase 2

See all FLECAINIDE ACETATE clinical trials

Pharmacology for FLECAINIDE ACETATE
Drug ClassAntiarrhythmic
Medical Subject Heading (MeSH) Categories for FLECAINIDE ACETATE
Anatomical Therapeutic Chemical (ATC) Classes for FLECAINIDE ACETATE

US Patents and Regulatory Information for FLECAINIDE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharm FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 075442-001 Jul 31, 2001 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 079164-003 Jul 9, 2009 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Ltd FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 076421-003 Mar 28, 2003 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 076030-002 Oct 28, 2002 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

FLECAINIDE ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Flecainide Acetate

Introduction to Flecainide Acetate

Flecainide acetate is a medication primarily used to prevent and treat abnormally fast heart rates, including ventricular and supraventricular tachycardias. Approved for medical use in the United States in 1985, it has been a staple in cardiac care for decades[2].

Market Size and Growth

The global flecainide acetate market has been experiencing significant growth driven by several key factors. As of 2023, the market size was valued at USD 1.4 billion and is projected to reach USD 2.6 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 8.2% from 2024 to 2031[4].

Drivers of Market Growth

Rising Prevalence of Cardiovascular Diseases

The increasing prevalence of cardiovascular diseases, particularly cardiac arrhythmias such as atrial fibrillation and ventricular tachycardia, is a major driver of the flecainide acetate market. As the global population ages, the incidence of these conditions is expected to rise, thereby increasing the demand for effective antiarrhythmic medications[3].

Advancements in Pharmaceutical Research

Continuous research and development in pharmaceuticals have led to improved formulations and delivery systems of flecainide acetate. For instance, the recent development of orally inhaled flecainide (FlecIH) for the conversion of atrial fibrillation to sinus rhythm highlights the innovative approaches being explored to enhance the drug's efficacy and safety[5].

Increasing Global Healthcare Investments

Growing investments in healthcare infrastructure and research are also contributing to the market's expansion. Improved healthcare facilities and increased funding for medical research are making flecainide acetate more accessible and effective[3].

Market Segmentation

The flecainide acetate market is segmented based on several criteria:

Type of Product

The market includes various forms of flecainide acetate such as tablets, extended-release capsules, injectable solutions, and oral suspensions. Each form caters to different patient needs and preferences, contributing to the market's diversity[4].

Application

Flecainide acetate is used in the treatment of various cardiac conditions, including arrhythmia treatment, heart rhythm disorders, atrial fibrillation, and ventricular tachycardia. The drug's versatility in treating different types of arrhythmias is a significant factor in its market growth[4].

Geographical Regions

The market is analyzed across different geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own market dynamics, influenced by local healthcare policies, patient demographics, and economic conditions[1][4].

Competitive Landscape

The flecainide acetate market is characterized by a mix of global key players and smaller manufacturers. Key players include those who market flecainide acetate under various brand names such as Tambocor, Almarytm, Apocard, Ecrinal, and Flécaine. The competitive landscape includes detailed analyses of company profiles, main business information, SWOT analyses, sales, revenue, price, and gross margin, as well as market share[1].

Supply and Demand Dynamics

The report provides a comprehensive analysis of the supply and demand dynamics of flecainide acetate across different regions. This includes data on the supply of flecainide acetate, demand by end-use, competition among players, type segmentation, and pricing strategies[1].

Trading Analysis

The global flecainide acetate market also involves significant trade activities. The report covers the export and import of flecainide acetate by region, balance of trade, and other trading-related metrics. This analysis helps in understanding the global distribution and consumption patterns of the drug[1].

Clinical and Therapeutic Significance

Flecainide acetate has been shown to be effective in treating various cardiac arrhythmias. A recent phase 2 multicenter study on orally inhaled flecainide (FlecIH) demonstrated a 90-minute cardioversion rate of nearly 50% in patients with atrial fibrillation, highlighting its potential as a rapid and effective treatment option[5].

Challenges and Limitations

Despite its efficacy, flecainide acetate has some limitations and potential risks. Studies have shown an increased mortality when flecainide is used to suppress ventricular extrasystoles in the setting of acute myocardial infarction. Therefore, careful patient selection and monitoring are crucial when prescribing this medication[2].

Future Outlook

The future of the flecainide acetate market looks promising, driven by the increasing prevalence of cardiac arrhythmias and advancements in pharmaceutical research. As healthcare infrastructure improves globally, the accessibility and demand for flecainide acetate are expected to rise, contributing to the market's continued growth.

Key Takeaways

  • The global flecainide acetate market is projected to grow from USD 1.4 billion in 2023 to USD 2.6 billion by 2031.
  • The market is driven by the rising prevalence of cardiovascular diseases, advancements in pharmaceutical research, and increasing global healthcare investments.
  • The drug is available in various forms, including tablets, extended-release capsules, injectable solutions, and oral suspensions.
  • Flecainide acetate is used in treating arrhythmia, heart rhythm disorders, atrial fibrillation, and ventricular tachycardia.
  • The market is segmented geographically, with key regions including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa.

FAQs

1. What is flecainide acetate used for?

Flecainide acetate is used to prevent and treat abnormally fast heart rates, including ventricular and supraventricular tachycardias.

2. What are the different forms of flecainide acetate available?

Flecainide acetate is available in various forms such as tablets, extended-release capsules, injectable solutions, and oral suspensions.

3. What are the key drivers of the flecainide acetate market?

The key drivers include the rising prevalence of cardiovascular diseases, advancements in pharmaceutical research, and increasing global healthcare investments.

4. What is the projected market size of flecainide acetate by 2031?

The market is expected to reach USD 2.6 billion by 2031, growing at a CAGR of 8.2% from 2024 to 2031.

5. What are some of the potential risks associated with flecainide acetate?

Flecainide acetate has been associated with increased mortality when used to suppress ventricular extrasystoles in the setting of acute myocardial infarction, and it can cause side effects such as cough, oropharyngeal discomfort, and cardiovascular adverse effects.

Cited Sources:

  1. Global Flecainide acetate (CAS 54153-56-5) Market Report 2019 - Valuates Reports
  2. Flecainide acetate - New Drug Approvals
  3. Flecainide - Market Research Intellect
  4. Flecainide Market Size and Projections - Market Research Intellect
  5. Orally Inhaled Flecainide for Conversion of AF to Sinus Rhythm - American College of Cardiology

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