Amiodarone hydrochloride - Generic Drug Details

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

Amiodarone hydrochloride is the generic ingredient in four branded drugs marketed by Acella, Bedford, Bedford Labs, Ben Venue, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Intl Medication Sys, Mylan Institutional, Par Sterile Products, Zhejiang Poly Pharm, Wyeth Pharms Inc, Baxter Hlthcare, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Sa, Norvium Bioscience, Rubicon, Taro, Teva, Teva Pharms, Unichem, Upsher Smith Labs, Zydus Pharms Usa Inc, and Wyeth Pharms, and is included in thirty-five NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Amiodarone hydrochloride has twenty-nine patent family members in thirteen countries.

There are ten drug master file entries for amiodarone hydrochloride. Thirty-four suppliers are listed for this compound.

Summary for amiodarone hydrochloride

International Patents:	29
US Patents:	1
Tradenames:	4
Applicants:	29
NDAs:	35
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	161
Patent Applications:	1,155
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for amiodarone hydrochloride
What excipients (inactive ingredients) are in amiodarone hydrochloride?	amiodarone hydrochloride excipients list
DailyMed Link:	amiodarone hydrochloride at DailyMed

Recent Clinical Trials for amiodarone hydrochloride

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

Sponsor	Phase
OHSU Knight Cancer Institute	Phase 2
Kun Hua	Phase 4
Rush University Medical Center	N/A

See all amiodarone hydrochloride clinical trials

Pharmacology for amiodarone hydrochloride

Drug Class	Antiarrhythmic
Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 3A4 Inhibitors

Medical Subject Heading (MeSH) Categories for amiodarone hydrochloride

Anti-Arrhythmia Agents

Cytochrome P-450 CYP1A2 Inhibitors

Cytochrome P-450 CYP2C9 Inhibitors

Cytochrome P-450 CYP2D6 Inhibitors

Cytochrome P-450 CYP3A Inhibitors

Potassium Channel Blockers

Sodium Channel Blockers

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for amiodarone hydrochloride

C01BD	Antiarrhythmics, class III
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

US Patents and Regulatory Information for amiodarone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rubicon	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	078578-003	Feb 26, 2021	AB	RX	No	No
Upsher Smith Labs	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	075315-001	Dec 23, 1998		DISCN	No	No
Hospira	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	INJECTABLE;INJECTION	075955-001	Oct 18, 2002		DISCN	No	No

Expired US Patents for amiodarone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-003	Nov 16, 2010
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-002	Nov 16, 2010

International Patents for amiodarone hydrochloride

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009134347
Eurasian Patent Organization	031355	КОМПОЗИЦИИ НА ОСНОВЕ СУЛЬФОАЛКИЛЬНЫХ ЭФИРОВ ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARATION THEREOF)
Mexico	2010004900	COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.)

Amiodarone hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amiodarone Hydrochloride

Introduction

Amiodarone hydrochloride, a class III antiarrhythmic drug, is widely used to treat and prevent various types of arrhythmias, including ventricular fibrillation, ventricular tachycardia, and atrial fibrillation. The market dynamics and financial trajectory of amiodarone hydrochloride are influenced by several key factors, which are crucial for understanding its current and future market position.

Market Drivers

Increasing Geriatric Population

The global population is aging, leading to an increased risk of life-threatening ventricular arrhythmias. This demographic shift significantly boosts the demand for amiodarone hydrochloride, as older adults are more prone to heart-related issues[1].

Rise in Sedentary Lifestyle

The growing trend of sedentary lifestyles among people has resulted in a higher incidence of heart-related problems and other chronic disorders. This lifestyle factor contributes to the increased demand for antiarrhythmic medications like amiodarone hydrochloride[1].

COVID-19 Impact

The COVID-19 pandemic has had a profound impact on the pharmaceutical industry, including the market for amiodarone hydrochloride. The pandemic has highlighted the importance of robust healthcare systems and the need for effective medications. While COVID-19 management has been the primary focus, the demand for other essential medications, including amiodarone, has remained steady or even increased in some cases due to the heightened awareness of healthcare needs[1].

Market Restraints

Side Effects

Despite its efficacy, amiodarone hydrochloride is associated with several significant side effects, such as pulmonary fibrosis, hypotension, and liver function test abnormalities. These adverse effects can hinder the market growth by limiting its use in certain patient populations and necessitating careful monitoring and management[5].

Competition from Alternative Drugs

The introduction of newer antiarrhythmic drugs like dronedarone has presented competition to amiodarone hydrochloride. Studies have shown that dronedarone can be more economical and effective in certain patient groups, particularly in maintaining sinus rhythm in patients with atrial fibrillation[3].

Market Trends

New Product Launches

The market for amiodarone hydrochloride has seen several new product launches and strategic acquisitions. For instance, Mayne Pharma Group Limited launched a generic version of amiodarone 200mg tablets in the U.S. in 2018. Additionally, Piramal Pharma Limited acquired Hemmo Pharmaceuticals Pvt Ltd. to enhance its product portfolio, including amiodarone hydrochloride[1].

Mergers and Acquisitions

The pharmaceutical industry is witnessing a trend of mergers and acquisitions, which can impact the market dynamics of amiodarone hydrochloride. These strategic moves help companies expand their product lines, improve manufacturing capabilities, and enhance market presence[1].

Cost-Effectiveness

Hospital Perspective

Studies have shown that the prophylactic use of amiodarone hydrochloride in patients undergoing coronary artery bypass grafting (CABG) can be cost-effective from a hospital perspective. The mean cost per atrial fibrillation event avoided was lower in the amiodarone group compared to the control group, highlighting its economic benefits in certain clinical settings[2].

Comparative Analysis with Dronedarone

A comparative study between dronedarone and amiodarone hydrochloride in the Chinese healthcare system revealed that dronedarone is more economical, with a lower incremental cost-effectiveness ratio (ICER) compared to amiodarone. However, this analysis is specific to the Chinese population and may not be universally applicable[3].

Market Size and Growth

The global market for amiodarone hydrochloride is expected to grow significantly over the next few years. The market size is projected to increase due to the rising demand for antiarrhythmic medications, driven by the increasing prevalence of heart-related disorders and the aging population. The U.S. and Canadian markets, in particular, are anticipated to see substantial growth, with the market estimated to expand from its current value to a higher figure by 2029[4].

Key Market Players

The amiodarone hydrochloride market is competitive, with several key players involved. These include Olon, Glenmark Pharma, Arevipharma, CTX Lifesciences, Unichem Laboratories Limited, Piramal Pharma Limited, Shanghai Pharmaceutical Group Co., Cambrex, Ltd, PMC Isochem, Sanofi, Zhejiang Sanmen Hengka, Globe Quimica Ltda, and United Pharma Industries. These companies are engaged in various strategies such as new product launches, acquisitions, and partnerships to maintain and expand their market share[1].

Regional Analysis

The market for amiodarone hydrochloride is segmented by region, with different regions exhibiting varying growth rates. The North American market, particularly the U.S. and Canada, is a significant segment due to the high prevalence of heart diseases and a well-established healthcare system. Other regions, including Europe and Asia-Pacific, also contribute substantially to the global market[1].

Financial Trajectory

Revenue Projections

The revenue generated from the sale of amiodarone hydrochloride is expected to increase over the forecast period. This growth is driven by the increasing demand for the drug, new product launches, and strategic expansions by key market players. The financial trajectory is also influenced by the cost-effectiveness of the drug in various clinical settings, which can lead to higher adoption rates[1][4].

Investment Opportunities

The amiodarone hydrochloride market presents several investment opportunities, particularly in the areas of research and development, manufacturing, and distribution. Companies are investing in improving the formulation and delivery of the drug to enhance its efficacy and reduce side effects. Additionally, investments in expanding distribution channels and entering new markets are expected to drive growth[1].

Regulatory Environment

The regulatory environment plays a crucial role in shaping the market dynamics of amiodarone hydrochloride. Regulatory approvals and guidelines can impact the availability and use of the drug. For instance, the FDA's approval of generic versions of amiodarone hydrochloride can increase competition and affect the market share of branded products[5].

Conclusion

The market for amiodarone hydrochloride is complex and influenced by multiple factors, including demographic changes, lifestyle trends, and the introduction of new drugs. Despite the challenges posed by side effects and competition, the market is expected to grow due to the increasing demand for antiarrhythmic medications.

Key Takeaways

• Growing Demand: The increasing geriatric population and sedentary lifestyles drive the demand for amiodarone hydrochloride.
• Cost-Effectiveness: Amiodarone hydrochloride is cost-effective in certain clinical settings, such as in patients undergoing CABG.
• Competition: Newer drugs like dronedarone present competition, but amiodarone remains a widely used option.
• Market Growth: The global market is expected to grow significantly over the next few years.
• Regulatory Environment: Regulatory approvals and guidelines impact the market dynamics.

FAQs

Q: What is amiodarone hydrochloride used for?

A: Amiodarone hydrochloride is used to treat and prevent various types of arrhythmias, including ventricular fibrillation, ventricular tachycardia, and atrial fibrillation.

Q: What are the major side effects of amiodarone hydrochloride?

A: Significant side effects include pulmonary fibrosis, hypotension, liver function test abnormalities, and cardiac disorders such as bradycardia and cardiogenic shock.

Q: How does the COVID-19 pandemic impact the amiodarone hydrochloride market?

A: The pandemic has highlighted the importance of robust healthcare systems and maintained or increased the demand for essential medications like amiodarone hydrochloride.

Q: Which regions are significant in the amiodarone hydrochloride market?

A: The North American market, particularly the U.S. and Canada, is a significant segment, along with Europe and Asia-Pacific.

Q: What are the investment opportunities in the amiodarone hydrochloride market?

A: Investment opportunities exist in research and development, manufacturing, and distribution, as well as in expanding distribution channels and entering new markets.

Sources

1. Allied Market Research - Amiodarone Hydrochloride Market Size | Segment Growth- 2030
2. PubMed - Cost-effectiveness of amiodarone for prophylaxis of atrial fibrillation
3. Frontiers in Public Health - Cost-Effectiveness of Dronedarone and Amiodarone for Atrial Fibrillation
4. News Channel Nebraska - Amiodarone Hydrochloride API Market 2024: Overview, Trends, and Rapid Growth Opportunities to 2032
5. DailyMed - NEXTERONE- amiodarone hydrochloride injection, solution