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Last Updated: July 29, 2025

Amiodarone hydrochloride - Generic Drug Details


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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
Recent Clinical Trials for amiodarone hydrochloride

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

SponsorPhase
OHSU Knight Cancer InstitutePhase 2
Kun HuaPhase 4
Rush University Medical CenterN/A

See all amiodarone hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for amiodarone hydrochloride

US Patents and Regulatory Information for amiodarone hydrochloride

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Dr Reddys Labs Sa AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075389-001 Jan 25, 2001 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Taro AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075424-002 Dec 18, 2002 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Ben Venue AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 076088-001 Oct 15, 2002 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Epic Pharma Llc AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 076232-001 Jul 5, 2006 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Acella AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 077834-001 Oct 30, 2008 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hospira AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 203884-001 Nov 25, 2013 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 6 of 6 entries

Expired US Patents for amiodarone hydrochloride

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-001 Dec 24, 2008 5,134,127 ⤷  Try for Free
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-001 Dec 24, 2008 6,869,939 ⤷  Try for Free
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-002 Nov 16, 2010 6,869,939 ⤷  Try for Free
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-001 Dec 24, 2008 5,376,645 ⤷  Try for Free
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-003 Nov 16, 2010 6,869,939 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 5 of 5 entries

International Patents for amiodarone hydrochloride

CountryPatent NumberTitleEstimated Expiration
China 105288650 Sulfoalkyl ether cyclodextrin compositions ⤷  Try for Free
China 101959508 Sulfoalkyl ether cyclodextrin compositions ⤷  Try for Free
China 114053423 磺烷基醚环糊精组合物 (Sulfoalkyl ether cyclodextrin compositions) ⤷  Try for Free
European Patent Office 2268269 COMPOSITIONS DE CYCLODEXTRINE À GROUPEMENTS ÉTHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS) ⤷  Try for Free
Japan 2012072160 SULFOALKYL ETHER CYCLODEXTRIN COMPOSITION ⤷  Try for Free
South Korea 101314803 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 6 of 6 entries

Market Dynamics and Financial Trajectory for Amiodarone Hydrochloride

Last updated: July 27, 2025


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.


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.


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.


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.


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.


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.


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.

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.


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.

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