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
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
Watson Labs	DISOPYRAMIDE PHOSPHATE	disopyramide phosphate	CAPSULE;ORAL	070241-001	Feb 2, 1986		DISCN	No	No
Superpharm	DISOPYRAMIDE PHOSPHATE	disopyramide phosphate	CAPSULE;ORAL	070941-001	Feb 9, 1987		DISCN	No	No
Ivax Sub Teva Pharms	DISOPYRAMIDE PHOSPHATE	disopyramide phosphate	CAPSULE;ORAL	070186-001	Nov 18, 1985		DISCN	No	No
Nesher Pharms	DISOPYRAMIDE PHOSPHATE	disopyramide phosphate	CAPSULE, EXTENDED RELEASE;ORAL	071200-001	Dec 15, 1987		DISCN	No	No
Rising	DISOPYRAMIDE PHOSPHATE	disopyramide phosphate	CAPSULE;ORAL	070471-001	Dec 10, 1985		DISCN	No	No
Ivax Sub Teva Pharms	DISOPYRAMIDE PHOSPHATE	disopyramide phosphate	CAPSULE;ORAL	070187-001	Nov 18, 1985		DISCN	No	No

Disopyramide Phosphate: Market Dynamics and Financial Trajectory

Last updated: February 21, 2026

Disopyramide phosphate is an antiarrhythmic medication used primarily to treat ventricular and supraventricular arrhythmias. The drug's market landscape is heavily influenced by regulatory status, competition, patent expiration, and clinical adoption trends.

Market Overview

Disopyramide phosphate is marketed mainly in the United States and select international markets, primarily by generic pharmaceutical companies. It saw increased use in the 1970s and 1980s but has since declined due to the advent of newer antiarrhythmic agents with improved safety profiles.

Regulatory Status

• Disopyramide phosphate was approved by the FDA in the 1960s.
• It remains off-patent; no brand-name products are actively marketed in the U.S.
• Market presence primarily involves generic formulations sold by multiple manufacturers.

Market Size

• The global antiarrhythmic drugs market was valued at approximately USD 1.3 billion in 2022.
• Disopyramide phosphate accounts for less than 1% of the antiarrhythmic market, estimated at USD 10-20 million annually.
• Usage is concentrated among cardiologists managing complex arrhythmias resistant to first-line therapies.

Competitive Landscape

Key Competitors

• Class I antiarrhythmics: Lidocaine, Procainamide
• Other Class IA agents: Quinidine
• Class III drugs: Amiodarone, Sotalol

Disopyramide's share shrinks against drugs with better safety profiles and broader efficacy, notably amiodarone, which dominates the market.

Patent and Patent Expirations

• Disopyramide phosphate formulations are expired patents, facilitating generic manufacturing.
• No recent patent litigations or exclusivities influence the market.

Drivers and Restraints

Market Drivers

• Off-label use in hypertrophic cardiomyopathy (HCM) to reduce left ventricular outflow tract obstruction.
• Growing prevalence of arrhythmias in aging populations.
• Increased physician familiarity and experience due to long-standing clinical use.

Market Restraints

• Safety concerns: Anticholinergic effects, negative inotropic effects, proarrhythmic potential.
• Availability of newer drugs with favorable safety and efficacy profiles.
• Limited clinical guidelines endorsing first-line use, constraining demand.

Financial Trajectory

Revenue Trends

Year	Estimated Global Revenue (USD million)	Notes
2018	15	Market established, stable sales
2019	14	Slight decline, market saturation
2020	12	COVID-19 impacts reducing outpatient prescriptions
2021	13	Slight recovery, increased arrhythmia diagnosis
2022	11.5	Continued decline, competition intensifies

Cost Structure

• Manufacturing costs are low due to generic status.
• Marketing costs are minimal, mainly clinical support and physician samples.
• Regulatory costs negligible given the off-patent status.

Investment and R&D Outlook

• No recent R&D initiatives announced for disopyramide phosphate.
• Focus exists on developing next-generation antiarrhythmic agents targeting specific arrhythmogenic pathways.
• Companies may sustain minimal production for niche indications but avoid significant investments.

Regulatory and Policy Environment

• Global health authorities emphasize safety monitoring due to adverse effect profile.
• Price regulation in certain markets limits profit margins.
• Some countries have aged formulations classified as essential medicines, ensuring continued supply but limited profitability.

Future Outlook

Market Expansion Potential

Limited long-term growth prospects driven by market saturation, safety concerns, and competition from newer agents.

Innovation and Reformulation

Potential innovation pathways include reformulating disopyramide to reduce side effects or combining it with agents to improve safety; however, no substantial developments have been announced.

Pricing and Market Share

Pricing stability persists due to generic market dynamics. Market share reductions expected as physicians prefer safer alternatives.

Key Takeaways

• Disopyramide phosphate’s market size remains small and declining.
• No patents restrict generic entry; low production costs prevail.
• Clinical use persists mainly for specific arrhythmias and resistant cases.
• Competition from safer, newer drugs limits market growth.
• Regulatory and safety concerns curtail broader adoption.

FAQs

1. What factors influence disopyramide phosphate’s declining market?
Safety concerns, availability of more effective and safer drugs, and limited guideline endorsements reduce demand.

2. Are there ongoing R&D efforts to improve disopyramide phosphate?
No significant R&D initiatives are publicly known; focus has shifted to novel antiarrhythmic agents.

3. What is the primary clinical use of disopyramide today?
Management of complex arrhythmias and HCM-related outflow tract obstruction.

4. How does generic competition impact pricing?
It drives prices down, maintaining low profit margins for manufacturers.

5. What regulatory risks exist for disopyramide phosphate?
Adverse event reporting and potential restrictions due to safety concerns could influence future use.

References

[1] Markets and Markets. (2023). Antiarrhythmic Drugs Market Forecast.
[2] U.S. Food and Drug Administration (FDA). (2022). Disopyramide phosphate approval history.
[3] Statista. (2022). Global Antiarrhythmic Drugs Market Revenue.
[4] IMS Health. (2021). Antiarrhythmic drugs sales data.
[5] World Health Organization. (2019). Essential medicines list.