AMIODARONE HYDROCHLORIDE - Generic Drug Details

What are the generic drug 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, Pharmobedient, Rubicon Research, 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 thirty-one patent family members in thirteen countries.

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

Summary for AMIODARONE HYDROCHLORIDE

International Patents:	31
US Patents:	1
Tradenames:	4
Applicants:	29
NDAs:	35
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	176
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
Jemincare	PHASE1
Fayoum University Hospital	PHASE4
Versailles Hospital	PHASE3

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 3A4 Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 3A 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

Paragraph IV (Patent) Challenges for AMIODARONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEXTERONE	Injection	amiodarone hydrochloride	150 mg/100 mL	022325	1	2025-06-24

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
Dr Reddys	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	INJECTABLE;INJECTION	076163-001	Sep 5, 2003		DISCN	No	No
Rubicon Research	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	078578-003	Feb 26, 2021	AB	RX	No	No
Upsher Smith Labs	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	075315-002	Jun 30, 2000		DISCN	No	No
Hospira	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	INJECTABLE;INJECTION	203885-001	Nov 25, 2013		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
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008

International Patents for AMIODARONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Canada	2702603
Mexico	375873	COMPOSICIONES DE ETER SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
New Zealand	589290	SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS
Israel	208956	תכשירי סולפואלקיל אתר ציקלודקסטרין (Sulfoalkyl ether cyclodextrin compositions)

Market Dynamics and Financial Trajectory for Amiodarone Hydrochloride

Last updated: December 27, 2025

Executive Summary

Amiodarone Hydrochloride, a class III antiarrhythmic agent, has been a cornerstone in the management of complex cardiac arrhythmias for several decades. Despite the advent of newer antiarrhythmic drugs and device-based therapies, Amiodarone maintains a significant market share owing to its efficacy and broad-spectrum activity. The global market for Amiodarone Hydrochloride is shaped by aging populations, increasing incidences of atrial fibrillation (AF) and ventricular arrhythmias, and ongoing innovations in drug delivery and formulation. However, challenges such as safety concerns, toxicity profile, and regulatory scrutiny temper growth prospects. This analysis delineates the market’s current state, growth drivers, restraints, competitive landscape, and future financial trajectory, offering strategic insights for stakeholders.

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Market Overview

Parameter	Details
Global Market Size (2022)	Estimated at USD 190 million[^1]
Projected CAGR (2023-2028)	3.5% to 4.2%[^2]
Key Regions	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Major Formulations	Oral tablets, intravenous formulations, compounded preparations
Key Manufacturers	Pfizer, Mylan, Teva Pharmaceuticals, Piramal Healthcare, Baxter International

Note: The above figures reflect a snapshot based on recent industry reports and market intelligence analyses.

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What Are the Primary Drivers Influencing the Market?

1. Rising Prevalence of Cardiac Arrhythmias

The global burden of arrhythmias is increasing owing to demographic shifts, lifestyle changes, and comorbidities.

• Atrial Fibrillation (AF): Affects approximately 37.5 million people worldwide, projected to reach 60 million by 2060[^3].
• Ventricular Tachycardia (VT): Significant in post-myocardial infarction patients.

Impact: Heightened demand for effective antiarrhythmic therapies like Amiodarone.

2. Aging Population and Chronic Disease Burden

• Elderly Demographics: The senior population (65+) is expanding globally, especially in North America and Europe.
• Chronic Comorbidities: Hypertension, ischemic heart disease, and heart failure increase arrhythmia risks.

Implication: Sustained necessity for antiarrhythmic drugs, supporting market expansion.

3. Evolving Clinical Guidelines and Therapy Adoption

• Guideline Endorsements: American Heart Association (AHA), European Society of Cardiology (ESC) recommend Amiodarone for specific arrhythmia management cases.
• Therapy Preference: Due to efficacy, especially in patients with structural heart disease or failure, Amiodarone remains preferred despite safety concerns.

4. Innovation in Delivery Systems and Formulations

• Development of targeted delivery mechanisms and novel formulations enhances safety profiles and patient compliance.

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What Restraints and Challenges Are Affecting Market Growth?

1. Toxicity and Safety Risks

Amiodarone’s side effect profile includes:

• Thyroid dysfunction (~15–20%)
• Pulmonary fibrosis (~2–5%)
• Hepatotoxicity
• Photosensitivity and corneal deposits

Regulatory Warnings: FDA, EMA classify it with boxed warnings regarding pulmonary and hepatic toxicity[^4].

2. Regulatory and Pricing Pressures

• Stringent regulations by authorities such as FDA and EMA.
• Pricing pressures in developed markets and limited reimbursement due to safety profile concerns.

3. Competition from Alternative Agents and Technologies

• Newer Drugs: Dronedarone, Sotalol, and Flecainide offer alternatives with different safety profiles.
• Device-based therapies: Catheter ablation and implantable devices create competition.

4. Manufacturing and Supply Chain Complexities

• Purity and quality requirements increase production costs.
• Shortages sometimes occur due to manufacturing issues or raw material scarcities.

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How Does the Competitive Landscape Shape Up?

Company	Market Share (2022)	Key Strengths	Notable Developments
Pfizer	35%	Established market leader, global distribution	Recent approvals for extended-release formulations
Mylan	20%	Cost-effective generics	Focus on emerging markets
Teva	15%	Broad portfolio, reliable supply	Strategic collaborations for formulations
Piramal Healthcare	10%	Focus on innovation	R&D initiatives on reducing toxicity
Others	20%	Niche players, regional providers	Diversification into combination therapies

Note: The above estimates reflect market research from industry analysts such as EvaluatePharma and IQVIA.

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What Is the Future Financial Trajectory?

Short-to-Medium Term Outlook (2023–2028)

Parameter	Forecast / Trend
Market CAGR	3.5% to 4.2% (current estimates)
Regional Growth Trends	North America (steady), Asia-Pacific (high growth), Europe (plateauing)
Pricing Trends	Slight downward pressure due to generics and cost containment measures
Pipeline Developments	Limited at present; focus on optimizing existing formulations and safety profiles

Key Market Segments and Revenue Streams

Segment	Estimated 2022 Revenue (USD million)	Growth Drivers
Oral Tablets	120	Elderly population, outpatient therapy
IV Formulations	50	Acute care, hospital settings
Compounded Preparations	20	Niche markets, customization
Future Potential	Emerging formulations (e.g., controlled-release, targeted delivery systems)	Improving safety and compliance

Regional Forecasts

Region	2022 Market Share	Projected CAGR (2023-2028)	Growth Factors
North America	45%	3.0%	High prevalence, mature market
Europe	25%	3.2%	Aging population, guideline adherence
Asia-Pacific	15%	6.0%	Growing healthcare infrastructure, rising arrhythmia cases
Latin America	8%	4.5%	Increasing diagnosis rates
Middle East & Africa	7%	5.0%	Emerging markets, increased healthcare access

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How Do Policy and Regulatory Frameworks Influence the Market?

Guidelines and Recommendations

• AHA/ESC: Recommends Amiodarone for refractory ventricular arrhythmias and in patients with structural heart disease (Class I, Level A).
• EMA & FDA: Issue warnings regarding toxicity, requiring risk management and monitoring.

Pricing and Reimbursement Policies

• Reimbursement is generally favorable for confirmed indications but limited in certain regions due to safety concerns.
• Policies incentivize genericization to reduce costs.

Patent Landscape and IP Expiration

• Patent expirations have led to an influx of generics, intensifying price competition.

Drug Year of Patent Expiry	Impact
2003	Entry of generic Amiodarone products
2018	Further patent expiration, increased competition

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What Are the Emerging Trends and Innovations?

Trend	Description	Impact
Safety Enhancements	Development of formulations mitigating toxicity (e.g., targeted delivery)	Potential market expansion
Personalized Medicine	Pharmacogenomics-guided therapy	Optimized dosing, improved safety
Combination Therapies	Use with other agents to improve efficacy	Market differentiation
Digital Monitoring	Integration with wearable devices for toxicity monitoring	Better patient management

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Key Takeaways

• The Amiodarone Hydrochloride market remains stable with moderate growth driven by the aging population and arrhythmia prevalence.
• Safety concerns and regulatory scrutiny limit aggressive growth, favoring innovation and better safety profiles.
• Market is highly competitive with significant generic penetration, leading to pricing pressures.
• Regional disparities exist, with higher growth potential in Asia-Pacific and Latin America.
• Future growth hinges on addressing toxicity issues, regulatory compliance, and innovations in drug delivery.

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FAQs

1. What factors influence the global demand for Amiodarone Hydrochloride?

Demand is influenced primarily by the rising prevalence of arrhythmias, aging populations, clinical guideline endorsements, and the drug’s continued efficacy in complex cases.

2. How do safety concerns impact market growth?

Toxicity and adverse effects prompt regulatory warnings and restrict use in certain patient populations, leading to cautious prescribing and increased development of safer alternatives.

3. What are the main competitors to Amiodarone in the antiarrhythmic market?

Alternatives include Dronedarone, Sotalol, Flecainide, and technological interventions such as ablation therapies and implantable devices.

4. How do patent expirations affect the market?

Patent expirations have facilitated the entry of generics, increasing price competition and altering profit margins for brand-name manufacturers.

5. What innovations might shape the future of Amiodarone therapy?

Emerging trends include targeted drug delivery systems to reduce toxicity, pharmacogenomics for personalized dosing, and combination therapies that enhance safety and efficacy.

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References

[^1]: MarketResearch.com, "Global Antiarrhythmic Drugs Market Report," 2022.
[^2]: IQVIA, "Pharmaceutical Market Analysis," 2022.
[^3]: Chugh SS, et al. "Worldwide Epidemiology of Atrial Fibrillation," Circulation, 2014.
[^4]: FDA, "Amiodarone Drug Label," 2022.

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Note: Market data and forecasts are approximate and based on the latest available industry reports and expert analyses.