PROPAFENONE HYDROCHLORIDE - Generic Drug Details

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

Propafenone hydrochloride is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Mylan, Rising, Sinotherapeutics Inc, Strides Pharma Intl, Twi Pharms, Upsher Smith Labs, Watson Labs Inc, Zydus Lifesciences, Glaxosmithkline Llc, Ani Pharms, Aurobindo Pharma, Nesher Pharms, Sun Pharm Industries, and Watson Labs, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for propafenone hydrochloride. Fifteen suppliers are listed for this compound.

Summary for PROPAFENONE HYDROCHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	16
NDAs:	18
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	29
Patent Applications:	1,922
What excipients (inactive ingredients) are in PROPAFENONE HYDROCHLORIDE?	PROPAFENONE HYDROCHLORIDE excipients list
DailyMed Link:	PROPAFENONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PROPAFENONE HYDROCHLORIDE

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

Sponsor	Phase
RenJi Hospital	Phase 4
Iuliu Hatieganu University of Medicine and Pharmacy	NA
Rabin Medical Center	Early Phase 1

See all PROPAFENONE HYDROCHLORIDE clinical trials

Pharmacology for PROPAFENONE HYDROCHLORIDE

Drug Class

Antiarrhythmic

Medical Subject Heading (MeSH) Categories for PROPAFENONE HYDROCHLORIDE

Anti-Arrhythmia Agents

Voltage-Gated Sodium Channel Blockers

Anatomical Therapeutic Chemical (ATC) Classes for PROPAFENONE HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for PROPAFENONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RYTHMOL SR	Extended-release Capsules	propafenone hydrochloride	325 mg	021416	1	2006-11-07
RYTHMOL SR	Extended-release Capsules	propafenone hydrochloride	225 mg and 425 mg	021416	1	2006-10-11

US Patents and Regulatory Information for PROPAFENONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Twi Pharms	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212928-002	Jun 18, 2020		DISCN	No	No
Ani Pharms	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	TABLET;ORAL	076550-002	Apr 23, 2004	AB	RX	No	No
Zydus Lifesciences	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	214184-003	Apr 21, 2021	AB	RX	No	No
Watson Labs	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	TABLET;ORAL	075203-001	Oct 24, 2000	AB	RX	No	No
Strides Pharma Intl	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	078540-002	Oct 18, 2010	AB	RX	No	No

Expired US Patents for PROPAFENONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-001	Sep 4, 2003
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-003	Sep 4, 2003
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-002	Sep 4, 2003

Market Dynamics and Financial Trajectory for Propafenone Hydrochloride

Last updated: July 28, 2025

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Introduction

Propafenone hydrochloride is a class IC antiarrhythmic agent primarily prescribed for the treatment of supraventricular arrhythmias and certain ventricular arrhythmias. Its unique pharmacological profile—combining sodium channel blockade with beta-adrenergic inhibition—positions it as a critical component in arrhythmia management. This analysis dissects the current market dynamics and projected financial outlook of Propafenone hydrochloride, considering global trends, regulatory landscapes, competitive environment, and emerging therapeutic developments.

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Pharmacological Profile and Clinical Demand

Propafenone hydrochloride has maintained clinical relevance for over three decades. It offers advantages like oral bioavailability, effectiveness in acute and chronic arrhythmias, and a relatively manageable side effect profile under proper monitoring. Despite the advent of newer antiarrhythmic agents, Propafenone remains an essential component in treatment protocols, especially in settings where alternatives such as amiodarone or sotalol are contraindicated or less effective.

Clinical guidelines, notably from the American Heart Association, continue to endorse Propafenone for specific arrhythmic conditions, thereby sustaining its demand across diverse healthcare systems[1]. The expanding burden of cardiovascular diseases globally also underpins consistent prescription volumes, particularly in aging populations.

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Market Size and Segmentation

The global antiarrhythmic drugs market was valued at approximately USD 2.0 billion in 2022, with Propafenone hydrochloride accounting for an estimated 12-15% of this segment[2]. Major markets include North America, Europe, and Asia-Pacific, with the latter experiencing rapid growth driven by increasing cardiovascular disease prevalence and rising healthcare infrastructure investments.

Segmentation is dictated by formulation—generic immediate-release or extended-release formulations—and by target indications, such as atrial fibrillation, atrial flutter, or ventricular tachycardia. Generic formulations predominate, supplied by multiple pharmaceutical manufacturers, exerting downward pressure on pricing and margins.

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Regulatory Landscape and Patent Expiry Impact

Propafenone hydrochloride's patent exclusivity expired approximately a decade ago, leading to a proliferation of generics. This expiration significantly compressed profit margins for brand-name manufacturers but expanded market accessibility.

Regulatory agencies globally have maintained rigorous standards for quality, efficacy, and safety. Variations in approval processes and pricing regulations across countries influence market entry strategies and profitability. In emerging markets, less stringent regulations can allow for quicker generic penetration but may also pose quality assurance risks.

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Competitive Environment

The pharmacological class of antiarrhythmic agents is highly competitive, with numerous generic options like flecainide, sotalol, and amiodarone. Propafenone faces competition not only from other drugs but also from devices and non-drug therapies, such as catheter ablation, which increasingly serve as first-line or adjunct treatments.

Manufacturers focus on differential strategies—such as formulation innovations (extended-release variants), combination therapies, and targeted marketing—to enhance market share. The availability of cost-effective generics remains the primary driver of accessibility but also contributes to intense pricing competition.

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Emerging Therapeutic Trends and Innovation

Advances in personalized medicine, genetic profiling, and device-based therapies could influence Propafenone’s long-term market trajectory. While new drug development in antiarrhythmics is ongoing, the complexity and safety profiles of emerging agents slow their rapid adoption.

Biotech companies are exploring gene therapy and novel mechanisms targeting arrhythmogenesis. These developments may gradually supercede small-molecule antiarrhythmics, but currently, Propafenone's established efficacy ensures its continual clinical relevance.

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Market Challenges

• Pricing pressures: Commoditization of generics limits revenue growth.
• Safety concerns: Risks of proarrhythmia and drug interactions necessitate careful patient selection, possibly constraining market expansion.
• Competition from device therapies: Increasing utilization of ablation procedures reduces dependence on drugs.
• Regulatory variations: Cross-country differences impact global distribution strategies.

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Financial Trajectory and Forecast

Prognostic models suggest a gradual decline in revenue growth over the next five years, primarily due to generic competition and market saturation in developed regions. However, developing markets are expected to offset some of these declines through increased adoption driven by rising cardiovascular morbidity.

Revenue projections estimate a compound annual growth rate (CAGR) of approximately 1-2% from 2023 to 2028 at a global level. Margins are likely to remain under pressure, with high-volume, low-margin generic sales dominating the landscape. R&D investments are anticipated to shift toward formulation improvements and combination therapies to sustain competitive positioning.

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Key Market Drivers

• Aging populations and rising cardiovascular disease prevalence globally.
• Continued clinical endorsement for Propafenone’s efficacy.
• Launch of extended-release formulations enhancing patient compliance.
• Expansion into emerging markets with growing healthcare infrastructure.

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Key Market Restraints

• Expiration of exclusivity rights leading to commoditization.
• Emergence of device-based and alternative pharmacological therapies.
• Stringent regulatory requirements increasing compliance costs.
• Pricing pressures and reimbursement challenges.

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Conclusion

Propafenone hydrochloride's market dynamics are characterized by steady clinical demand tempered by aggressive generic competition and evolving therapeutic strategies. While immediate prospects for revenue growth may be limited, the compound's entrenched position within antiarrhythmic treatment arsenals ensures a sustained, if gradually declining, market presence. Strategic focus areas include formulation innovation, geographical expansion, and integration with novel therapy modalities to enhance long-term financial sustainability.

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Key Takeaways

• Market Saturation: Expiration of patents and proliferation of generics have resulted in intense price competition, constraining profit margins.
• Growth Opportunities: Emerging markets, formulation innovations, and combination therapies offer avenues for maintaining revenue streams.
• Competitive Shifts: Increasing preference for device-based interventions may influence prescription trends in the coming decade.
• Regulatory and Safety Considerations: Ongoing safety monitoring and compliance are vital to sustain market access.
• Strategic Focus: Companies should prioritize differentiation through formulation enhancements and geographic expansion to counteract competitive pressures.

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FAQs

1. How does patent expiry affect the market for propafenone hydrochloride?
Patent expiry opens the market to generic manufacturers, significantly reducing prices and profit margins for brand-name producers. It encourages widespread availability but challenges brand loyalty and market exclusivity.

2. What are the primary competitors to propafenone hydrochloride in the antiarrhythmic segment?
Primary competitors include drugs such as flecainide, sotalol, and amiodarone. Additionally, device-based therapies like catheter ablation increasingly serve as alternatives.

3. Are there recent innovations in propafenone hydrochloride formulations?
Extended-release formulations have been developed to improve patient adherence and tolerability, representing a key innovation to sustain market relevance.

4. How might emerging therapies impact the demand for propafenone hydrochloride?
Emerging gene therapies and novel drug classes could reduce reliance on traditional antiarrhythmics, potentially diminishing long-term demand unless Propafenone adapts through combination therapies or improved delivery methods.

5. What markets present the best growth opportunities for propafenone hydrochloride?
Emerging economies in Asia-Pacific and Latin America, where cardiovascular disease prevalence is rising and regulatory barriers are less stringent, offer substantial growth prospects.

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References

[1] American Heart Association. (2021). Guidelines for the Management of Patients with Supraventricular Arrhythmias.

[2] MarketWatch. (2022). Antiarrhythmic Drugs Market Size and Forecast.