Procainamide hydrochloride - Generic Drug Details

What are the generic drug sources for procainamide hydrochloride and what is the scope of patent protection?

Procainamide hydrochloride is the generic ingredient in seven branded drugs marketed by Ani Pharms, Ascot, Ivax Sub Teva Pharms, Lannett, Lederle, Roxane, Vangard, Watson Labs, Parke Davis, Panray, Apothecon, Abraxis Pharm, Caplin, Gland, Hikma, Hospira, Intl Medication, Nexus, Pharmafair, Smith And Nephew, Solopak, Warner Chilcott, West-ward Pharms Int, Inwood Labs, Sandoz, Parkedale, and King Pharms, and is included in seventy-two NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for procainamide hydrochloride. Eleven suppliers are listed for this compound.

Summary for procainamide hydrochloride

US Patents:	0
Tradenames:	7
Applicants:	27
NDAs:	72
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	16
Patent Applications:	2,106
What excipients (inactive ingredients) are in procainamide hydrochloride?	procainamide hydrochloride excipients list
DailyMed Link:	procainamide hydrochloride at DailyMed

Recent Clinical Trials for procainamide hydrochloride

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

Sponsor	Phase
Abant Izzet Baysal University	N/A
Jeffrey Moak	Phase 4
Ottawa Hospital Research Institute	Phase 4

See all procainamide hydrochloride clinical trials

Pharmacology for procainamide hydrochloride

Drug Class

Antiarrhythmic

Medical Subject Heading (MeSH) Categories for procainamide hydrochloride

Anti-Arrhythmia Agents

Voltage-Gated Sodium Channel Blockers

Anatomical Therapeutic Chemical (ATC) Classes for procainamide hydrochloride

C01BA	Antiarrhythmics, class Ia
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

US Patents and Regulatory Information for procainamide hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	TABLET, EXTENDED RELEASE;ORAL	089369-001	Aug 14, 1987		DISCN	No	No
Apothecon	PRONESTYL	procainamide hydrochloride	INJECTABLE;INJECTION	007335-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Lederle	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	CAPSULE;ORAL	086952-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	PROCAINAMIDE HYDROCHLORIDE	procainamide hydrochloride	INJECTABLE;INJECTION	087080-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for procainamide hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms	PROCANBID	procainamide hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020545-002	Jan 31, 1996
King Pharms	PROCANBID	procainamide hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020545-001	Jan 31, 1996

Market Dynamics and Financial Trajectory for Procainamide Hydrochloride

Last updated: July 28, 2025

Introduction

Procainamide hydrochloride, a well-established antiarrhythmic agent, remains integral to the management of cardiac arrhythmias, particularly atrial fibrillation and ventricular arrhythmias. While primarily accessible via traditional pharmaceutical channels, its market landscape is evolving due to regulatory, technological, and demographic shifts. This analysis explores the market dynamics influencing procainamide hydrochloride’s trajectory, evaluates the financial prospects, and considers competitive, regulatory, and clinical factors shaping its future.

Pharmaceutical Overview and Clinical Utility

Procainamide hydrochloride acts by stabilizing cardiac membranes, thereby suppressing abnormal electrical activity. Its long-standing clinical application stems from over seven decades of use, with a well-characterized safety and efficacy profile. Despite the advent of newer agents, procainamide remains a vital option in specific contexts, especially when tailored to patients with contraindications to alternative therapies.

Current formulations are predominantly marketed as generic products, with minimal proprietary variation. The uniqueness of the drug lies in its classification as an off-patent medication, which influences both pricing dynamics and market competition.

Market Dynamics Influencers

Regulatory Environment

Procainamide hydrochloride's off-patent status renders it less susceptible to rigorous patent challenges; however, regulatory approvals significantly influence market access and expansion. The Drug Regulatory Authorities (DRAs) across regions enforce standards that impact manufacturing practices, stability, and bioequivalence requirements. Recent initiatives aiming to streamline generic drug approvals could bolster broader availability but might also increase market saturation with multiple suppliers.

Manufacturing and Supply Chain Factors

Manufacturing scalability, quality control, and supply chain robustness directly impact procurement costs and market stability. Several manufacturers operate in emerging economies, offering cost-effective production but facing challenges related to standardization and regulatory compliance. Disruptions, such as those observed during global crises (e.g., COVID-19), can lead to shortages, influencing clinical prescribing patterns and market share distribution.

Demographic Trends

Aging populations worldwide, particularly in North America, Europe, and parts of Asia, collectively augment demand for antiarrhythmic medications. The increasing prevalence of atrial fibrillation—projected to affect over 33 million globally by 2030—positions procainamide as a relevant therapeutic option, albeit within a competitive landscape predominantly occupied by newer drugs.

Competitive Landscape

While direct competition from other sodium-channel blockers and antiarrhythmics—such as quinidine, amiodarone, and lidocaine—exists, procainamide faces competition from agents with improved safety profiles or simplified administration. However, its cost-effectiveness and established clinical experience bolster its position in resource-constrained settings and specific clinical scenarios.

Clinical Practice and Prescribing Trends

Shifts in clinical guidelines influence utilization rates. Recently, emphasis has been placed on newer agents with optional safety profiles, such as amiodarone, which may marginalize procurement of procainamide in certain territories. Nonetheless, in contexts demanding cost containment or specific contraindications, procainamide retains relevance.

Financial Trajectory Analysis

Market Revenue and Pricing

Given the generic nature of procainamide hydrochloride, profit margins are relatively narrow. Industry estimates suggest global sales in the range of $50 million annually—primarily driven by regional markets in emerging economies. Price sensitivity is high, with significant variability based on manufacturing origin, formulation quality, and regulatory pricing controls.

Market Growth Projections

The compound annual growth rate (CAGR) for procainamide hydrochloride is projected to remain modest—approximately 1-3% over the next five years—barring significant policy shifts or new indications. Factors constraining growth include the waning preference for older antiarrhythmics in developed markets and regulatory pressures favoring newer agents.

Emerging Opportunities

In regions lacking advanced healthcare infrastructure, procainamide’s low-cost profile sustains solid demand. Opportunities exist for manufacturing partnerships involving high-quality generics that meet international standards, allowing entry into markets where affordability takes precedence.

Potential for Innovation

Although traditional formulations dominate, there is limited scope for new patentable formulations or delivery systems, given its status and the existence of established generics. Nonetheless, advancements in stability or combination therapies could marginally influence future revenue streams.

Regulatory and Political Risks

Healthcare policies favoring consolidated formularies or promoting newer, patent-protected drugs could suppress overall demand for procainamide. Additionally, regulatory scrutiny on drug safety may necessitate reformulation or enhanced pharmacovigilance, incrementally increasing costs or limiting available formulations.

Strategic Considerations

• Market Penetration: Focused efforts on emerging markets and resource-limited settings, where affordability remains paramount.

• Branding and Education: Promoting clinical confidence in procainamide's efficacy may reinforce its positioning in therapeutic guidelines.

• Regulatory Engagement: Navigating approval processes efficiently to capitalize on regional markets with unmet needs.

Conclusion

Procainamide hydrochloride’s market is characterized by stability amidst modest growth, driven by demographic trends and its cost-effective profile. Regulatory and clinical practice shifts are potential limiting factors, yet strategic positioning in underserved regions sustains its relevance. The financial trajectory suggests a conservative outlook, reinforcing the importance of targeted market approaches and ongoing cost optimization.

Key Takeaways

• Stable Market with Regional Variability: Procainamide hydrochloride maintains steady demand in emerging markets, with limited growth prospects in developed regions due to competition from newer drugs.

• Cost-Effectiveness as a Competitive Edge: Its off-patent status and affordability are critical advantages in resource-limited settings.

• Supply Chain and Regulatory Factors Are Pivotal: Manufacturing quality and regulatory compliance significantly influence availability and pricing.

• Demographic Drivers Sustain Demand: Aging populations with rising atrial fibrillation prevalence keep the drug relevant.

• Potential for Strategic Market Expansion: Tailored initiatives targeting underserved regions could bolster revenues despite overall slow growth.

FAQs

1. What are the main clinical indications for procainamide hydrochloride?
Procainamide is primarily used to treat atrial fibrillation, atrial flutter, and ventricular arrhythmias, especially when other agents are contraindicated or unsuitable.

2. How does the off-patent status of procainamide affect its market?
Being off-patent leads to increased generic competition, lowering prices and margins. It also facilitates broader manufacturing and distribution but limits opportunities for proprietary innovations.

3. What are the key regulatory challenges facing procainamide?
Regulatory challenges include ensuring manufacturing quality, obtaining approvals in new markets, and adhering to evolving pharmacovigilance requirements, particularly in regions with strict drug safety standards.

4. How does demographic aging influence future demand?
An aging global population increases atrial fibrillation prevalence, driving consistent demand for antiarrhythmic drugs, including procainamide, especially in regions with expanding elderly demographics.

5. Are there opportunities for innovation or new formulations?
Limited; existing formulations are well-established. Innovation opportunities may include improved stability, ease of administration, or combination therapies, but patent opportunities are scarce.

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Sources:

[1] World Health Organization. (2020). Cardiovascular diseases (CVDs).
[2] MarketResearch.com. (2021). Global antiarrhythmic drugs market report.
[3] US Food and Drug Administration (FDA). Drug Approvals and Labeling.
[4] International Pharmaceutical Regulators Forum. (2022). Generic drug approval pathways.