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, 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
Hospira	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	INJECTABLE;INJECTION	076108-001	Oct 15, 2002		DISCN	No	No
Hospira	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	INJECTABLE;INJECTION	203885-001	Nov 25, 2013		DISCN	No	No
Aurobindo Pharma Ltd	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	204742-001	Jun 3, 2016	AB	RX	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	022325-003	Nov 16, 2010	6,869,939
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008	5,134,127
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-002	Nov 16, 2010	6,869,939

International Patents for AMIODARONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201000828
Japan	2017019879	スルホアルキルエーテルシクロデキストリン組成物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
China	114053423

Market Dynamics and Financial Trajectory for Amiodarone Hydrochloride

Last updated: July 27, 2025

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Introduction

Amiodarone Hydrochloride, a class III antiarrhythmic agent, has been a cornerstone in managing various cardiac arrhythmias since its introduction. Its unique efficacy in treating complex arrhythmia cases, particularly ventricular fibrillation and ventricular tachycardia, has sustained its relevance despite emerging therapies. As the pharmaceutical landscape evolves, understanding the market dynamics and financial trajectory of Amiodarone Hydrochloride is crucial for stakeholders, including manufacturers, investors, and healthcare providers.

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Historical Overview and Therapeutic Landscape

Developed in the 1960s and FDA-approved in the 1980s, Amiodarone’s initial success was driven by its broad antiarrhythmic profile. Its long half-life (approximately 58 days) and complex pharmacokinetics pose both advantages, such as sustained effects, and challenges, including drug accumulation and toxicity risks. Despite the advent of newer agents like dronedarone and sotalol, Amiodarone remains a preferred option, especially in high-risk patient populations where efficacy outweighs adverse effects [1].

The drug’s stability and efficacy have preserved its demand, especially in regions with well-established healthcare infrastructure. However, the emergence of alternative therapies and growing awareness of side effects influence prescribing patterns and market share.

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Market Drivers

Clinical Efficacy and Safety Profile

Amiodarone’s proven effectiveness in controlling complex arrhythmias sustains its use. Its ability to suppress a wide range of arrhythmias offers a therapeutic advantage over more selective agents. Nevertheless, safety concerns, notably pulmonary toxicity, thyroid dysfunction, and hepatic side effects, necessitate careful monitoring, which can impact prescribing decisions and market growth.

Prevalence of Cardiac Arrhythmias

The increasing prevalence of atrial fibrillation, ventricular arrhythmia, and associated cardiovascular diseases globally drive demand. Aging populations contribute significantly, with the World Heart Federation citing a rise in arrhythmia cases correlating with demographic aging [2].

Healthcare Infrastructure and Prescribing Practices

Developed countries with established cardiology treatment protocols and access to pharmacological therapies support robust demand for Amiodarone. Conversely, in emerging markets, access issues and alternative therapies influence market penetration.

Regulatory and Patent Landscape

Amiodarone is generic in many jurisdictions, leading to low cost and high accessibility. Patent expirations have facilitated widespread manufacturing, intensifying price competition but also expanding market reach.

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Market Challenges

Toxicity and Safety Concerns

Long-term adverse effects restrict use in some cases, prompting the development of newer agents with improved safety profiles [3].

Emergence of Newer Antiarrhythmic Drugs

Drugs like dronedarone and other class III agents aim to provide similar efficacy with fewer side effects, potentially cannibalizing Amiodarone’s market share.

Regulatory Restrictions

Stringent prescribing guidelines due to toxicity risks limit its use to specific patient populations, impacting volume growth.

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Financial Trajectory and Market Valuation

Current Market Size

The global Amiodarone market was valued at approximately USD 120 million in 2022, with steady growth driven by increased arrhythmia prevalence. The Asia-Pacific region exhibits the fastest growth, propelled by rising cardiovascular diseases and expanding healthcare access.

Growth Projections

Analysts project a compound annual growth rate (CAGR) of around 4% from 2023 to 2030, reaching an estimated USD 180 million. The compound growth is supported by demographic trends, increasing adoption in developing countries, and ongoing clinical validation.

Market Segmentation

• Formulation Type: Injectable (used in hospital settings) and oral tablets.
• End-User: Hospitals (>60%), specialty clinics, and home healthcare.
• Geographical Distribution: North America (largest share), Europe, Asia-Pacific, Latin America, and MEA.

Profitability Considerations

The generic status of Amiodarone keeps prices competitive. Profit margins are influenced by manufacturing costs, regulatory compliance, and distribution channels. Biosimilar and generic players dominate, asserting pricing pressure but broadening access.

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Future Outlook

Innovative Formulations and Delivery

Research into alternative delivery systems, such as controlled-release formulations, aims to optimize efficacy and minimize toxicity, potentially shifting the market dynamics.

Regulatory and Clinical Developments

Enhanced safety monitoring protocols and updated prescribing guidelines may influence utilization patterns. Ongoing clinical studies exploring Amiodarone’s long-term outcomes and toxicity mitigation are pivotal.

Market Penetration in Emerging Economies

Expanding healthcare infrastructure and rising cardiovascular disease burdens in Asia-Pacific and Latin America are expected to sustain demand, driven by affordability and regulatory approvals.

Impact of Digital Health and Monitoring

Integration of remote cardiac monitoring may enhance safety, allowing for broader, more confident usage, thus influencing market growth positively.

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Key Takeaways

• Steady Demand Amidst Challenges: Despite safety concerns and competition from newer agents, Amiodarone Hydrochloride maintains a significant market share, especially in high-risk patient segments.
• Growing Market in Developing Regions: Asia-Pacific and Latin America represent high-growth opportunities due to increasing cardiovascular disease prevalence and expanding healthcare infrastructure.
• Pricing and Competition Dynamics: Generics dominate the market, ensuring affordability but constraining profit margins for manufacturers.
• Innovation and Safety Enhancements: Future formulations aiming to reduce toxicity may redefine market positioning and usage protocols.
• Regulatory and Clinical Influences: Evolving guidelines and toxicity management will shape prescribing behaviors and market size over the next decade.

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FAQs

1. What are the primary factors driving demand for Amiodarone Hydrochloride?
Demand is primarily driven by the prevalence of complex arrhythmias, demonstrated clinical efficacy, and its longstanding position as a treatment staple in hospital settings.

2. How does the safety profile of Amiodarone impact its market dynamics?
Concerns about toxicity restrict long-term use and influence clinician preferences, encouraging development of alternative therapies, but the drug remains essential for high-risk cases where benefits outweigh risks.

3. What is the outlook for Amiodarone market growth in emerging regions?
The Asia-Pacific region and Latin America are expected to see increased adoption fueled by rising cardiovascular disease incidence and expanding healthcare access, contributing to a robust CAGR.

4. How do patent expirations influence the Amiodarone market?
Patent expirations have facilitated widespread manufacturing of generics, leading to price competition, broader access, and steady demand but reduced profit margins for brand-name producers.

5. What innovations could reshape the future of Amiodarone Hydrochloride?
Developments in targeted delivery systems, toxicity reduction formulations, and pharmacovigilance-enhancing remote monitoring could extend its market relevance.

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References

[1] American Heart Association. (2021). Management of Arrhythmias.
[2] World Heart Federation. (2020). Global Prevalence of Cardiac Arrhythmias.
[3] European Society of Cardiology. (2018). Clinical Practice Guidelines on Arrhythmia Management.