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, Chartwell, Hikma, Regcon Holdings, 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:	1
Clinical Trials:	5
Patent Applications:	1,584
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, Inc.	Phase 2
InCarda Therapeutics Australia Pty Ltd.	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
Ani Pharms	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	075882-002	Oct 28, 2002	AB	RX	No	No
Sun Pharm Inds Ltd	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	076421-002	Mar 28, 2003	AB	RX	No	No
Amneal Pharm	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	075442-002	Jul 31, 2001	AB	RX	No	No
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-004	Aug 23, 1988		DISCN	Yes	No
Ani Pharms	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	076030-003	Oct 28, 2002		DISCN	No	No
Yichang Humanwell	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	215599-003	Sep 8, 2022	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	018830-003	Jun 3, 1988
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-002	Oct 31, 1985
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-004	Aug 23, 1988
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-003	Jun 3, 1988
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-003	Jun 3, 1988
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-001	Oct 31, 1985

Market Dynamics and Financial Trajectory for Flecainide Acetate

Last updated: July 27, 2025

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Introduction

Flecainide acetate is a prominent antiarrhythmic medication primarily used to treat atrial fibrillation, atrial flutter, and ventricular arrhythmias. As a Class IC agent, it is renowned for its efficacy in managing complex arrhythmias resistant to other therapeutic options. Over recent years, market trends, regulatory shifts, and evolving cardiovascular treatment paradigms have significantly influenced the drug’s market dynamics and financial outlook.

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Market Overview

Global Demand and Therapeutic Use

Flecainide acetate’s worldwide application is driven by the rising prevalence of atrial fibrillation (AF), which affects an estimated 33 million individuals globally, a figure projected to rise in tandem with aging populations and increasing cardiovascular risk factors [1]. The drug holds a substantial share in second-line antiarrhythmic therapies, especially in developed markets like North America and Europe, where arrhythmia management is sophisticated and protocol-driven.

Key Market Segments and Sources

The primary sources of revenue for flecainide acetate stem from prescription sales in hospitals, specialty clinics, and outpatient settings. Generic versions have entered multiple markets, impacting pricing strategies and revenue streams for branded formulations.

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Market Dynamics

1. Regulatory Environment and Patent Landscape

Flecainide acetate was first approved in the United States in the late 1980s, with subsequent approvals worldwide. Patent expirations for the original formulations have led to a surge in generic entrants, exerting downward pressure on prices [2]. Regulatory agencies’ emphasis on safety surveillance and post-marketing studies has also influenced market stability, especially after concerns relating to proarrhythmic risk surfaced in certain patient subsets.

2. Competitive Landscape

The antiarrhythmic drug market features several classes: sodium channel blockers, beta-blockers, and other Class IC agents. Flecainide’s main competitors include propafenone, amiodarone, and sotalol. Generic competition has significantly diversified options, with generics capturing a larger share, thereby affecting branded drug revenues.

3. Technological and Clinical Developments

Advances in catheter ablation and wearable cardiac monitoring devices have transformed arrhythmia management. These technologies sometimes supplant pharmacologic therapy, impacting the demand for antiarrhythmic drugs. Nevertheless, flecainide acetate remains relevant for patients unsuitable for invasive procedures or where pharmacologic control is essential.

4. Market Penetration and Regional Variations

North America accounts for a substantial portion of the market, driven by robust healthcare infrastructure, high disease prevalence, and expert cardiology centers. Europe follows, with growing adoption in Eastern European countries. Asian markets exhibit expanding demand owing to increasing cardiovascular disease burden and improved healthcare access. However, regulatory approvals vary, influencing regional market size.

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Financial Trajectory

1. Market Revenue Trends

The pharmaceutical market research indicates that, prior to the patent expirations around the early 2000s, branded flecainide formulations contributed significantly to pharmaceutical revenues, estimated at over $200 million annually in the U.S. alone [3]. Post-generic entry, revenues declined sharply, with current estimates placing global sales at approximately $50 million to $75 million annually, predominantly from branded sales in niche markets.

2. Impact of Patent Expiry and Generics

Patent expiry catalyzed generic manufacturing, precipitating a 60–70% reduction in drug prices. Generic competition has diminished profit margins for innovator companies but expanded drug accessibility. The financial trajectory now hinges on market share, pricing strategies, and regional regulations favoring or restricting generic substitution.

3. Future Revenue Projections

Analysts anticipate a plateau or slight decline in revenue in established markets due to the shift towards device-based therapies and novel drugs with improved safety profiles. However, for emerging markets and specialized indications (e.g., pediatric arrhythmias), niche growth opportunities could partially offset declines.

4. R&D and Portfolio Diversification

Pharmaceutical companies are shifting R&D focus toward personalized medicine, gene therapy, and safer antiarrhythmic agents. Flecainide acetate’s future financial viability may be affected by innovations that either complement or replace current usage, influencing investments and marketing strategies.

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Emerging Trends and Opportunities

• Biomarker-Guided Therapy: Enhanced patient stratification could optimize flecainide use, potentially restoring confidence in its safety profile and expanding indications.
• Combination Regimens: Use with other agents to improve efficacy may create new market segments.
• Regulatory Approvals in Developing Countries: Growth opportunities lie in expanding approvals and manufacturing for emerging markets, where cardiovascular disease prevalence is rising.

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Challenges and Risks

• Safety Concerns: Proarrhythmic risks associated with flecainide necessitate careful patient selection and limit widespread adoption.
• Market Saturation: Mature markets are highly commoditized, with low margins due to generics.
• Technological Displacement: Advancements in ablation technologies threaten long-term reliance on pharmacotherapy.

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Key Takeaways

• The market for flecainide acetate is characterized by a high dependence on mature markets, with declining revenues driven by generics and competition from device therapies.
• Regulatory pressures and safety profiles are pivotal factors influencing market dynamics.
• Opportunities exist in emerging markets and niche indications, contingent on regulatory approval and clinical evidence.
• The shift toward personalized medicine and technological innovations poses both risks and opportunities for the drug’s financial trajectory.
• Companies investing in newer, safer antiarrhythmic agents may influence the future landscape of flecainide acetate’s market share.

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FAQs

1. What are the main therapeutic indications for flecainide acetate?
Flecainide acetate is primarily used to treat atrial fibrillation, atrial flutter, and certain ventricular arrhythmias, especially in patients who do not respond to or cannot tolerate other therapies.

2. How have patent expirations affected the market for flecainide acetate?
Patent expirations have led to increased generic manufacturing, significantly reducing drug prices and revenues for branded formulations, while expanding access in various regions.

3. What are the safety concerns associated with flecainide acetate?
Potential proarrhythmic effects, especially in patients with structural heart disease or those prone to ischemia, limit its use and call for rigorous patient selection and monitoring.

4. How do technological advances impact the demand for flecainide acetate?
Emerging therapies like catheter ablation and advanced monitoring have reduced reliance on pharmacological management, potentially constraining market growth.

5. What strategic opportunities exist for pharmaceutical companies regarding flecainide acetate?
Expanding into emerging markets, developing combination therapies, and establishing biomarkers for safer use present avenues for growth amid competitive pressures.

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References

[1] Global Burden of Disease Study. (2019). Cardiovascular diseases statistics.
[2] U.S. Food and Drug Administration. (2022). Drug Approvals and Patent Expirations.
[3] MarketWatch. (2021). Antiarrhythmic Drugs Market Revenue Analysis.