FLECAINIDE ACETATE - Generic Drug Details

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

Flecainide acetate is the generic ingredient in two branded drugs marketed by Amneal Pharm, Ani Pharms, Aurobindo Pharma Ltd, Beximco Pharms Usa, Chartwell, Hikma, Sun Pharm Inds Ltd, Yichang Humanwell, and Alvogen, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for flecainide acetate. Fifteen suppliers are listed for this compound.

Summary for FLECAINIDE ACETATE

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	10
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	5
Patent Applications:	1,193
Drug Prices:	Drug price trends for FLECAINIDE ACETATE
What excipients (inactive ingredients) are in FLECAINIDE ACETATE?	FLECAINIDE ACETATE excipients list
DailyMed Link:	FLECAINIDE ACETATE at DailyMed

See drug prices for FLECAINIDE ACETATE

Recent Clinical Trials for FLECAINIDE ACETATE

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

Sponsor	Phase
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 Class

Antiarrhythmic

Medical Subject Heading (MeSH) Categories for FLECAINIDE ACETATE

Anti-Arrhythmia Agents

Voltage-Gated Sodium Channel Blockers

Anatomical Therapeutic Chemical (ATC) Classes for FLECAINIDE ACETATE

C01BC	Antiarrhythmics, class Ic
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

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
Beximco Pharms Usa	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	210683-003	Sep 16, 2020	AB	RX	No	No
Beximco Pharms Usa	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	210683-002	Sep 16, 2020	AB	RX	No	No
Ani Pharms	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	075882-001	Oct 28, 2002	AB	RX	No	No
Hikma	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	076278-003	Jan 14, 2003	AB	RX	No	Yes
Beximco Pharms Usa	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	210683-001	Sep 16, 2020	AB	RX	No	No

Expired US Patents for FLECAINIDE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-002	Oct 31, 1985	3,900,481
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-001	Oct 31, 1985	4,005,209
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-003	Jun 3, 1988	4,642,384
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-004	Aug 23, 1988	3,800,481
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-003	Jun 3, 1988	3,900,481

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