Disopyramide phosphate - Generic Drug Details

What are the generic sources for disopyramide phosphate and what is the scope of patent protection?

Disopyramide phosphate is the generic ingredient in three branded drugs marketed by Nesher Pharms, Pfizer, Dr Reddys Labs Sa, Interpharm, Ivax Sub Teva Pharms, Mylan, Rising, Sun Pharm Industries, Superpharm, Teva, and Watson Labs, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for disopyramide phosphate. Five suppliers are listed for this compound.

Summary for disopyramide phosphate

US Patents:	0
Tradenames:	3
Applicants:	11
NDAs:	20
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	1
Patent Applications:	2,049
What excipients (inactive ingredients) are in disopyramide phosphate?	disopyramide phosphate excipients list
DailyMed Link:	disopyramide phosphate at DailyMed

Recent Clinical Trials for disopyramide phosphate

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

Sponsor	Phase
University of Oxford	N/A
University of Aberdeen	N/A

See all disopyramide phosphate clinical trials

Pharmacology for disopyramide phosphate

Drug Class

Antiarrhythmic

Medical Subject Heading (MeSH) Categories for disopyramide phosphate

Anti-Arrhythmia Agents

Voltage-Gated Sodium Channel Blockers

Anatomical Therapeutic Chemical (ATC) Classes for disopyramide phosphate

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

US Patents and Regulatory Information for disopyramide phosphate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ivax Sub Teva Pharms	DISOPYRAMIDE PHOSPHATE	disopyramide phosphate	CAPSULE;ORAL	070186-001	Nov 18, 1985		DISCN	No	No
Ivax Sub Teva Pharms	DISOPYRAMIDE PHOSPHATE	disopyramide phosphate	CAPSULE;ORAL	070187-001	Nov 18, 1985		DISCN	No	No
Interpharm	DISOPYRAMIDE PHOSPHATE	disopyramide phosphate	CAPSULE;ORAL	071191-001	Jan 15, 1987		DISCN	No	No

Market Dynamics and Financial Trajectory for Disopyramide Phosphate

Last updated: July 30, 2025

---

Introduction

Disopyramide phosphate, a class Ic antiarrhythmic agent, has maintained a niche presence within the cardiovascular therapeutic marketplace. Despite its longstanding clinical use, its market share, financial outlook, and future trajectory are influenced by evolving clinical guidelines, competitive dynamics, regulatory landscapes, and technological advancements in arrhythmia management. This comprehensive analysis explores the current market landscape, factors influencing its financial trajectory, and strategic considerations for stakeholders.

---

Pharmacological Profile and Clinical Use

Disopyramide phosphate functions as a sodium channel blocker, primarily used to treat ventricular and supraventricular arrhythmias. Its negative inotropic effects necessitate caution in patients with heart failure, limiting its broader application. Nonetheless, it remains a valuable option in cases resistant to other therapies, often used alongside other antiarrhythmic drugs or in specialized settings such as cardiothoracic surgery.

Current Market Landscape

Market Size and Penetration

The global antiarrhythmic drugs market was valued at approximately USD 2.5 billion in 2022, with disopyramide accounting for a small but stable segment—estimated to be less than 2% of this figure, equating to roughly USD 50 million annually. Its usage is predominantly concentrated in North America and Europe, where established treatment guidelines and practitioner familiarity sustain its limited, yet persistent, demand.

Manufacturers and Selling Dynamics

Major pharmaceutical firms such as Teva Pharmaceuticals, Mylan (now part of Viatris), and Ferrosan (a Danish biotech) historically supplied disopyramide. The drug’s off-patent status has led to multiple generic versions, reducing price points and profit margins but increasing accessibility.

Regulatory Environment

Disopyramide's approval statuses remain consistent across major markets, classified as a well-established, prescription-only medication. However, strict regulatory oversight concerning safety profiles, especially related to proarrhythmic risks and negative inotropic effects, influences labeling and prescribing practices.

Market Dynamics Influencing Disopyramide Phosphate

Clinical Practice Trends

Recent shifts toward catheter-based ablation for arrhythmias has decreased the reliance on pharmacological management, including disopyramide. The focus on non-pharmacological interventions in atrial fibrillation and ventricular tachycardia reduces the prescription volume of older antiarrhythmics.

Guideline Preferences and Recommendations

Leading cardiology guidelines (e.g., American Heart Association, European Society of Cardiology) prioritize newer agents with improved safety profiles, such as flecainide, propafenone, or amiodarone. This preference marginalizes disopyramide, relegating it to salvage therapy in specific cases.

Safety and Side-Effect Profile

Disopyramide’s notable anticholinergic side effects—dry mouth, urinary retention, blurred vision—alongside its proarrhythmic potential, have limited its broader adoption. Manufacturers and prescribers generally favor safer alternatives, impacting commercial viability.

Financial Trajectory and Future Outlook

Revenue Trends

With declining prescriptions, disopyramide's revenue trajectory faced stagnation or slight decay over the past decade. The market’s contraction is evidenced by dwindling sales figures reported by generic manufacturers, coupled with reduced new usage.

Patent and Regulatory Outlook

The absence of patent protection has encouraged generics, intensifying price competition. R&D investments in new formulations or delivery systems are minimal, constraining product innovation and further impinging on potential revenue growth.

Emerging Technologies and Therapeutic Alternatives

Advances in catheter ablation, implantable devices, and gene therapy are progressively replacing pharmacological approaches, undermining demand for disopyramide. The resurgence of interest in personalized medicine encourages tailored, minimally invasive procedures over traditional drug regimens.

Strategic Considerations for Stakeholders

• Manufacturers: Focus on niche markets or special indications, possibly developing combination therapies or extended-release formulations to differentiate offerings.
• Healthcare Providers: Emphasize evidence-based selection, reserving disopyramide for refractory cases or specific physiological contraindications.
• Regulators: Maintain rigorous safety standards to ensure risk mitigation, potentially easing access for appropriately selected patients.
• Investors: Exercise caution given the drug’s declining revenue prospects, but explore opportunities within specialized or orphan indications where unmet medical needs persist.

---

Conclusion

Disopyramide phosphate's market dynamics are characterized by a declining trajectory driven by clinical advancements, safety concerns, and shifting treatment paradigms favoring minimally invasive procedures. Its financial outlook reflects subdued growth, primarily sustained by generics and niche applications. For stakeholders, strategic positioning necessitates adapting to evolving clinical practices, focusing on specialized indications, and considering innovative formulations to prolong its market relevance.

---

Key Takeaways

• Disopyramide phosphate's share in the global antiarrhythmic market is diminishing, constrained by safety concerns and evolving treatment modalities.
• The drug remains relevant within niche indications and refractory cases but faces stiff competition from catheter-based interventions and newer drugs with improved safety profiles.
• Generics dominate its supply chain, exerting downward pressure on prices and profit margins.
• Future growth prospects are limited without significant innovation or emergence of novel indications.
• Stakeholders should consider strategic positioning in specialized markets and continued safety monitoring to sustain drug utility.

---

FAQs

1. What are the primary clinical indications for disopyramide phosphate?
Disopyramide is mainly prescribed for ventricular and supraventricular arrhythmias, especially in cases resistant to other therapies. Its use is limited in patients with heart failure due to negative inotropic effects.

2. Why is the market share of disopyramide declining?
The decline stems from safety concerns, alternative treatments like catheter ablation, and preferences for newer antiarrhythmic agents with more favorable safety profiles.

3. Are there any recent developments or innovations related to disopyramide?
Currently, there are minimal innovations. Focus is on optimizing existing formulations, with limited R&D efforts aimed at new delivery systems or combination therapies.

4. How do regulatory agencies influence the future of disopyramide?
Regulators enforce safety standards, which can limit its use in certain populations. However, no significant regulatory hurdles are currently threatening its market status.

5. What strategic moves should manufacturers consider to sustain disopyramide sales?
Manufacturers could target niche indications, develop combination formulations, or explore orphan or resistant arrhythmia markets where alternatives are limited.

---

References

1. Market research reports (e.g., Grand View Research, MarketsandMarkets).
2. Clinical guidelines from AHA and ESC on arrhythmia management.
3. Manufacturer data and drug approval summaries (FDA, EMA).
4. Scientific articles on disopyramide’s efficacy, safety, and clinical usage trends.