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:	46
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
Sun Pharm Industries	DISOPYRAMIDE PHOSPHATE	disopyramide phosphate	CAPSULE;ORAL	070352-001	Dec 17, 1985		DISCN	No	No
Sun Pharm Industries	DISOPYRAMIDE PHOSPHATE	disopyramide phosphate	CAPSULE;ORAL	070351-001	Dec 17, 1985		DISCN	No	No
Dr Reddys Labs Sa	DISOPYRAMIDE PHOSPHATE	disopyramide phosphate	CAPSULE;ORAL	070173-001	May 31, 1985	AB	RX	No	No
Watson Labs	DISOPYRAMIDE PHOSPHATE	disopyramide phosphate	CAPSULE;ORAL	070241-001	Feb 2, 1986		DISCN	No	No
Rising	DISOPYRAMIDE PHOSPHATE	disopyramide phosphate	CAPSULE;ORAL	070471-001	Dec 10, 1985		DISCN	No	No

DISOPYRAMIDE PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Disopyramide Phosphate

Introduction

Disopyramide phosphate, a Type 1 antiarrhythmic drug, has been a staple in the treatment of arrhythmias and cardiac conditions since its approval in 1977. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting key trends, growth drivers, and challenges.

Market Size and Growth

The global disopyramide phosphate market is anticipated to experience significant growth over the forecast period from 2024 to 2031. The market size in 2023 was substantial, and it is expected to grow at a compound annual growth rate (CAGR) of several percent during the forecast period[1][4].

Segment Analysis

The market is segmented based on several key factors:

Type

The market is segmented into different types of disopyramide phosphate products, with Norpace and Rythmodan being prominent. The Norpace segment accounted for a noticeable share of the global market in 2023 and is projected to experience significant growth in the near future[1][4].

Application

The drug is used across various age groups, including geriatric, adolescents, children, and infants. The geriatric segment is particularly significant due to the higher prevalence of arrhythmias in older populations[4].

Geography

The market is divided into major regions such as North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. Each region has its own set of contributing countries, and the revenue share and current trends vary significantly across these regions[1][4].

Key Drivers and Opportunities

Several factors drive the growth of the disopyramide phosphate market:

Increasing Prevalence of Arrhythmias

The rising incidence of arrhythmias and other cardiac conditions, particularly among the aging population, drives the demand for effective treatments like disopyramide phosphate[3].

Efficacy and Safety Profile

Disopyramide phosphate has a well-established efficacy and safety profile, having been in use for over four decades. This long-standing presence in the market enhances its credibility and acceptance among healthcare providers[3].

Market Expansion Strategies

Key companies such as Sanofi, Teva, and Pfizer are focusing on expanding their product portfolios and business in the global market. These strategies include geographical expansion, partnerships, and innovative marketing approaches[1][4].

Challenges and Restraints

Despite the growth potential, the market faces several challenges:

Side Effects and Safety Concerns

Disopyramide phosphate can cause or worsen congestive heart failure, produce severe hypotension, and lead to other anticholinergic side effects. These safety concerns can limit its use in certain patient populations[2][5].

Competition from Alternative Treatments

The antiarrhythmic drug market is competitive, with other drugs and treatments available. This competition can impact the market share of disopyramide phosphate[3].

Financial Performance and Forecast

The financial performance of the disopyramide phosphate market is robust, with significant revenue generated from sales across various regions. Here are some key financial insights:

Revenue Growth

The market is expected to grow substantially in terms of revenue from 2024 to 2031, driven by increasing demand and expanding market reach[1][4].

Regional Revenue Share

North America and Europe are significant contributors to the global revenue, but the Asia-Pacific region is expected to show rapid growth due to increasing healthcare expenditure and a large patient population[1][4].

Competitor Analysis

The market is dominated by several key players:

Pfizer Inc.

As the original developer and marketer of disopyramide phosphate, Pfizer Inc. holds a significant position in the market. Other companies like Sanofi, Teva, and Novartis AG also play crucial roles[1][3][4].

Market Trends and Opportunities

Several trends are shaping the market:

Geographical Expansion

Companies are focusing on expanding their presence in emerging markets, particularly in Asia-Pacific and Latin America, where there is a growing demand for antiarrhythmic drugs[1][4].

Research and Development

Continuous R&D efforts are aimed at improving the efficacy and safety profile of disopyramide phosphate. This includes studies on new formulations and dosing regimens[3].

Consumer Behavior and Preferences

Consumer behavior plays a crucial role in the market dynamics:

Patient Compliance

Patients with arrhythmias often require long-term treatment, making patient compliance a critical factor. The tolerability and effectiveness of disopyramide phosphate influence patient adherence to the treatment regimen[2].

Regulatory Environment

The regulatory environment is another key factor:

Approval Status

Disopyramide phosphate has been approved globally, including in the United States and China. Regulatory approvals and compliance are essential for market growth[3].

Technological and Clinical Trends

Advancements in technology and clinical practices also impact the market:

Clinical Trials and Studies

Ongoing clinical trials and studies continue to evaluate the efficacy and safety of disopyramide phosphate, providing valuable insights for future development and market positioning[2][3].

SWOT Analysis

A SWOT analysis highlights the strengths, weaknesses, opportunities, and threats:

Strengths

• Established efficacy and safety profile
• Wide global approval
• Strong market presence of key players

Weaknesses

• Potential side effects and safety concerns
• Competition from alternative treatments

Opportunities

• Expanding market in emerging regions
• Continuous R&D for improved formulations

Threats

• Regulatory changes
• Competitive market landscape[1][3][4]

Key Takeaways

• The disopyramide phosphate market is expected to grow significantly from 2024 to 2031.
• The Norpace segment and hospital pharmacy segment are key contributors to the market.
• Geographical expansion, especially in Asia-Pacific, is a major growth driver.
• Safety concerns and competition are significant challenges.
• Continuous R&D and regulatory compliance are crucial for market success.

FAQs

Q: What is disopyramide phosphate used for? A: Disopyramide phosphate is primarily used for the treatment of arrhythmias and cardiac conditions.

Q: Who are the key players in the disopyramide phosphate market? A: Key players include Pfizer Inc., Sanofi, Teva, and Novartis AG.

Q: What are the potential side effects of disopyramide phosphate? A: The drug can cause anticholinergic side effects, worsen congestive heart failure, and produce severe hypotension.

Q: What is the forecasted growth rate of the disopyramide phosphate market? A: The market is expected to grow at a significant CAGR from 2024 to 2031.

Q: In which regions is the disopyramide phosphate market expected to grow rapidly? A: The Asia-Pacific region is expected to show rapid growth due to increasing healthcare expenditure and a large patient population.

Cited Sources

1. Cognitive Market Research, "Disopyramide Phosphate Market Report 2024 (Global Edition)".
2. PubMed, "Long-term Therapy With Disopyramide Phosphate: Side Effects and Efficacy".
3. Synapse, "Disopyramide Phosphate's R&D Progress and its Mechanism of Action".
4. Market Research Intellect, "Global Disopyramide Phosphate Sales Market Size and Forecast".
5. Pfizer Labeling, "Disopyramide Phosphate Capsules".