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Last Updated: January 4, 2025

CORDARONE Drug Patent Profile


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Which patents cover Cordarone, and when can generic versions of Cordarone launch?

Cordarone is a drug marketed by Wyeth Pharms Inc and Wyeth Pharms and is included in two NDAs.

The generic ingredient in CORDARONE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cordarone

A generic version of CORDARONE was approved as amiodarone hydrochloride by TEVA PHARMS on November 30th, 1998.

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Summary for CORDARONE
Drug patent expirations by year for CORDARONE
Recent Clinical Trials for CORDARONE

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

SponsorPhase
OHSU Knight Cancer InstitutePhase 2
University of CalgaryPhase 4
University Hospital, CaenPhase 4

See all CORDARONE clinical trials

US Patents and Regulatory Information for CORDARONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Pharms Inc CORDARONE amiodarone hydrochloride INJECTABLE;INJECTION 020377-001 Aug 3, 1995 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wyeth Pharms CORDARONE amiodarone hydrochloride TABLET;ORAL 018972-001 Dec 24, 1985 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

CORDARONE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Cordarone (Amiodarone Hydrochloride)

Introduction to Cordarone

Cordarone, also known as amiodarone hydrochloride, is a powerful antiarrhythmic medication primarily used to treat life-threatening ventricular arrhythmias. It belongs to the Class III category of antiarrhythmic drugs, known for its complex pharmacokinetics and significant side effect profile.

Market Size and Growth

The global amiodarone hydrochloride market is anticipated to experience significant growth over the coming years. Several factors contribute to this growth:

  • Increasing Geriatric Population: The rise in the geriatric population increases the risk of sudden deaths due to life-threatening ventricular arrhythmias, thereby boosting the demand for amiodarone hydrochloride[1].
  • Sedentary Lifestyle: The growing incidence of heart-related problems and other chronic disorders, largely attributed to sedentary lifestyles, also drives the market growth[1].

Market Segmentation

The amiodarone market can be segmented based on several criteria:

  • By Drug Type: The market includes various forms of amiodarone, such as tablets and injectables. In 2023, the tablet segment accounted for a noticeable share of the global amiodarone market and is projected to experience significant growth[4].
  • By Purity Level: Different purity levels of amiodarone hydrochloride are available, catering to various clinical and research needs.
  • By Distribution Channel: The drug is distributed through hospitals, pharmacies, and online platforms.
  • By Region: The market is analyzed across major regions including North America, Europe, Asia Pacific, South America, and the Middle East and Africa. Each region has its own growth trajectory based on local healthcare infrastructure and demand[4].

Key Market Players

The amiodarone hydrochloride market is competitive, with several key players:

  • Sanofi: Known for its branded version, Cordarone.
  • Piramal Pharma Limited: Expanding its product portfolio through strategic acquisitions.
  • Glenmark Pharma: Active in the generic market.
  • Olon: Another significant player in the amiodarone hydrochloride market[1].

Market Trends

New Product Launches

Recent years have seen the launch of generic alternatives to Cordarone, such as Mayne Pharma Group Limited's amiodarone 200mg tablets in the U.S. in 2018. These launches have helped in increasing market competition and accessibility of the drug[1].

Mergers and Acquisitions

Companies like Piramal Pharma Limited have been involved in strategic acquisitions, such as the takeover of Hemmo Pharmaceuticals Pvt Ltd., to enhance their product portfolios and market presence[1].

Driving Factors

Several factors drive the growth of the amiodarone hydrochloride market:

  • High Demand for Antiarrhythmic Drugs: The increasing incidence of heart-related disorders and the need for effective antiarrhythmic treatments drive the demand for amiodarone hydrochloride[1].
  • COVID-19 Impact: The COVID-19 pandemic has highlighted the importance of robust pharmaceutical and biotechnology industries, leading to increased investment and growth opportunities in the sector, including the amiodarone market[1].

Restraints and Challenges

Despite the growth potential, the amiodarone hydrochloride market faces several challenges:

  • Side Effects: Amiodarone is associated with significant side effects, including pulmonary toxicity, liver injury, and cardiac complications. These side effects can hinder market growth and affect patient compliance[2][3].
  • Complex Pharmacokinetics: The drug has a long half-life and complex elimination phases, requiring careful dosing and monitoring, which can be challenging for both patients and healthcare providers[2][3].

Financial Trajectory

The financial trajectory of the amiodarone hydrochloride market is promising, with several indicators pointing towards growth:

  • Compound Annual Growth Rate (CAGR): The global amiodarone market is expected to grow at a significant CAGR from 2024 to 2031, driven by increasing demand and new product launches[4].
  • Market Size: The global market size for amiodarone is estimated to grow substantially over the forecast period, with the tablet segment expected to retain a significant share[4].

Regional Analysis

The market growth varies by region, influenced by local healthcare systems, regulatory environments, and patient demographics:

  • North America and Europe: These regions are expected to dominate the market due to advanced healthcare infrastructure and high demand for antiarrhythmic drugs.
  • Asia Pacific: This region is anticipated to show significant growth due to increasing healthcare expenditure and a large patient population[4].

Competitive Analysis

The competitive landscape of the amiodarone hydrochloride market is intense, with several players competing for market share:

  • Porter’s Five Forces Analysis: This analysis highlights the potency of buyers and suppliers, competitive intensity, and the threat of new entrants and substitutes, providing insights into the market's competitive dynamics[1].

Future Projections

The future of the amiodarone hydrochloride market looks promising, with several factors contributing to its growth:

  • Increasing Demand: The growing need for effective antiarrhythmic treatments and the expanding geriatric population will continue to drive demand.
  • New Product Developments: Ongoing research and development are expected to lead to new product launches and improved formulations, enhancing market growth[1][4].

Key Takeaways

  • The amiodarone hydrochloride market is driven by the increasing incidence of heart-related disorders and the growing geriatric population.
  • Significant side effects and complex pharmacokinetics are major challenges.
  • The market is expected to grow at a substantial CAGR from 2024 to 2031.
  • Key players are focusing on strategic acquisitions and new product launches to strengthen their market presence.
  • Regional growth varies, with North America and Europe expected to dominate the market.

FAQs

What are the primary indications for Cordarone?

Cordarone is indicated for the treatment of life-threatening recurrent ventricular arrhythmias, including recurrent ventricular fibrillation and hemodynamically unstable ventricular tachycardia, when other antiarrhythmics have failed or cannot be tolerated[3].

What are the common side effects of Cordarone?

Common side effects include pulmonary toxicity, liver injury, cardiac complications such as sinus bradycardia or heart block, and other systemic effects like skin discoloration and thyroid dysfunction[2][3].

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

The COVID-19 pandemic has increased the demand for antiarrhythmic drugs and highlighted the importance of robust pharmaceutical and biotechnology industries, leading to increased investment and growth opportunities in the sector[1].

What is the expected CAGR for the global amiodarone market from 2024 to 2031?

The global amiodarone market is expected to grow at a significant CAGR from 2024 to 2031, though the exact percentage is not specified in the available data[4].

Which segment is expected to dominate the amiodarone market in the near future?

The tablet segment is projected to retain a significant share and experience substantial growth in the near future[4].

Sources

  1. Allied Market Research: Amiodarone Hydrochloride Market Size | Segment Growth- 2030
  2. FDA: Cordarone® (amiodarone HCl) TABLETS
  3. FDA: Cordarone - accessdata.fda.gov
  4. Cognitive Market Research: Amiodarone Market Report 2024 (Global Edition)

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