DRONEDARONE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for dronedarone hydrochloride and what is the scope of freedom to operate?

Dronedarone hydrochloride is the generic ingredient in two branded drugs marketed by Lupin and Sanofi Aventis Us, and is included in two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dronedarone hydrochloride has fifty-seven patent family members in twenty-eight countries.

There are nineteen drug master file entries for dronedarone hydrochloride. Two suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for DRONEDARONE HYDROCHLORIDE

International Patents:	57
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	34
Patent Applications:	197
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DRONEDARONE HYDROCHLORIDE
DailyMed Link:	DRONEDARONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DRONEDARONE HYDROCHLORIDE

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

Sponsor	Phase
Shanghai East Hospital	Phase 4
Stony Brook University	Phase 3
China National Center for Cardiovascular Diseases	Phase 4

See all DRONEDARONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for DRONEDARONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		400MG	TABLET;ORAL
		400MG	TABLET;ORAL
		400MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for DRONEDARONE HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for DRONEDARONE HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for DRONEDARONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MULTAQ	Tablets	dronedarone hydrochloride	400 mg	022425	7	2013-07-01

US Patents and Regulatory Information for DRONEDARONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	AB	RX	Yes	Yes
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	AB	RX	Yes	Yes
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	AB	RX	Yes	Yes
Lupin	DRONEDARONE HYDROCHLORIDE	dronedarone hydrochloride	TABLET;ORAL	205904-001	Jan 31, 2024	AB	RX	No	No

Expired US Patents for DRONEDARONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009

International Patents for DRONEDARONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
South Korea	20100135814	USE OF DRONEDARONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, FOR THE PREPARATION OF A MEDICAMENT FOR REGULATING THE POTASSIUM LEVEL IN THE BLOOD
Nicaragua	201000173	USO DE DRONEDARONA O UNA SAL ACEPTABLE FARMACÉUTICAMENTE DE ÉSTA, PARA LA PREPARACIÓN DE UN MEDICAMENTO PARA REGULAR EL NIVEL DE POTASIO EN LA SANGRE.
China	102065855	Use of dronedarone for the preparation of a medicament for use in the prevention of cardiovascular hospitalization or of mortality
Peru	20091777	DRONEDARONA O UNA SAL ACEPTABLE FARMACEUTICAMENTE DE LA MISMA

Supplementary Protection Certificates for DRONEDARONE HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1007030	SPC/GB10/029	United Kingdom		PRODUCT NAME: DRONEDARONE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/09/591/001 20091126; UK EU/1/09/591/002 20091126; UK EU/1/09/591/003 20091126; UK EU/1/09/591/004 20091126
1007030	10C0031	France		PRODUCT NAME: DRONEDARONE; REGISTRATION NO/DATE IN FRANCE: EU/1/09/591/001 DU 20091126; REGISTRATION NO/DATE AT EEC: EU/1/09/591/001-004 DU 20091126
1007030	2010008	Ireland		THE CORRECT SPC EXTENSION DATE IS 20230618 (NOT 20230616); PRODUCT NAME: DRONEDARONE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/09/591/001-004 20091126

DRONEDARONE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Dronedarone Hydrochloride

Introduction

Dronedarone hydrochloride, marketed under the brand name Multaq, is an antiarrhythmic drug used primarily for the management of atrial fibrillation (AF) and atrial flutter. The market dynamics and financial trajectory of this drug are influenced by several factors, including clinical efficacy, safety concerns, regulatory approvals, and market competition.

Clinical Efficacy and Safety Profile

Dronedarone has demonstrated efficacy in reducing the recurrence of AF and decreasing the incidence of hospitalization for cardiac causes and all-cause mortality in certain patient populations. Clinical trials such as the DAFNE and ATHENA studies have shown that dronedarone can decrease AF recurrence by approximately 25% and reduce cardiovascular hospitalizations and arrhythmic deaths[2][5].

However, the safety profile of dronedarone is complex and has significant implications for its market dynamics. The drug is contraindicated in patients with severe heart failure (class III or IV) due to increased mortality risk, as observed in the ANDROMEDA and PALLAS trials. Additionally, dronedarone has been associated with increased risks of stroke, heart failure, and death in patients with permanent AF[3][5].

Regulatory Environment

The FDA approval of dronedarone in 2009 was a significant milestone, but subsequent safety reviews have led to changes in its labeling and usage recommendations. The FDA has advised against using dronedarone in patients with permanent AF who cannot or will not be converted to normal sinus rhythm, and recommends regular ECG monitoring to ensure the patient remains in sinus rhythm[3][5].

Market Size and Growth

The global dronedarone hydrochloride market is analyzed in terms of market size, revenue, and growth rate. The market is expected to grow, albeit cautiously, due to the drug's niche application and safety concerns. Reports indicate that the market will see a moderate CAGR from 2025 to 2031, driven by the increasing prevalence of atrial fibrillation and the need for effective antiarrhythmic treatments[1][4].

Regional Analysis

The market for dronedarone hydrochloride is segmented by region, with North America and Europe being key markets due to higher awareness and adoption of the drug. However, the growth in these regions is tempered by the stringent regulatory environment and the need for careful patient selection. Emerging markets may offer potential for growth, but this will depend on regulatory approvals and healthcare infrastructure[1][4].

Competitive Landscape

Dronedarone competes with other antiarrhythmic agents, including amiodarone, which has a broader range of indications but also more side effects. The competitive landscape is influenced by the safety and efficacy profiles of these drugs, as well as their pricing and market penetration. Dronedarone's unique selling point is its potentially lower toxicity profile compared to amiodarone, but this is offset by its limited indications and safety concerns[2][5].

Market Trends

Several trends are shaping the market for dronedarone hydrochloride:

Increasing Prevalence of Atrial Fibrillation

The growing incidence of AF, particularly in aging populations, drives the demand for effective antiarrhythmic treatments[5].

Safety Concerns and Regulatory Scrutiny

The increased risk of serious cardiovascular events in certain patient groups has led to stricter regulatory guidelines and caution among healthcare providers, impacting market growth[3][5].

Technological Advancements

Advancements in drug delivery systems and monitoring technologies could enhance the safety and efficacy of dronedarone, potentially expanding its market[2].

Patient Selection and Monitoring

The need for careful patient selection and regular monitoring to avoid adverse effects is a critical trend, influencing both the prescribing habits of healthcare providers and the overall market dynamics[3][5].

Financial Trajectory

The financial performance of dronedarone hydrochloride is closely tied to its market dynamics. Here are some key financial aspects:

Revenue and Market Share

Despite safety concerns, dronedarone generates significant revenue due to its unique position in the antiarrhythmic market. However, its market share is limited by the need for selective use and the availability of alternative treatments[1][4].

Cost and Pricing

The pricing of dronedarone is a critical factor, especially in regions with stringent healthcare budgets. The drug's cost-effectiveness, balanced against its safety and efficacy, influences its adoption rates[4].

Research and Development

Continuous research and development are essential to address the safety concerns and expand the indications for dronedarone. This involves significant investment, which can impact the financial trajectory of the drug[2].

Challenges and Opportunities

Challenges

• Safety Concerns: The increased risk of cardiovascular events, heart failure, and stroke in certain patient groups is a significant challenge.
• Regulatory Scrutiny: Stricter regulatory guidelines and labeling changes can limit market growth.
• Competition: The presence of other antiarrhythmic agents with broader indications poses a competitive challenge.

Opportunities

• Growing Demand: The increasing prevalence of AF offers a growing market for effective antiarrhythmic treatments.
• Technological Advancements: Improvements in drug delivery and monitoring technologies can enhance safety and efficacy.
• Emerging Markets: Potential for growth in emerging markets where healthcare infrastructure is developing[1][4].

Key Takeaways

• Dronedarone hydrochloride has a niche market due to its efficacy in managing AF and atrial flutter, but its use is limited by safety concerns.
• The drug's market dynamics are influenced by regulatory approvals, safety profiles, and competitive landscape.
• Despite challenges, the market is expected to grow moderately, driven by the increasing prevalence of AF and technological advancements.
• Careful patient selection and regular monitoring are crucial for maximizing the benefits of dronedarone while minimizing risks.

FAQs

Q: What is the primary indication for dronedarone hydrochloride?

A: Dronedarone hydrochloride is primarily indicated for the management of atrial fibrillation (AF) and atrial flutter.

Q: Why is dronedarone contraindicated in patients with severe heart failure?

A: Dronedarone is contraindicated in patients with severe heart failure (class III or IV) due to increased mortality risk observed in clinical trials.

Q: How does dronedarone compare to amiodarone in terms of safety and efficacy?

A: Dronedarone has a potentially lower toxicity profile compared to amiodarone but is limited by its narrower indications and specific safety concerns.

Q: What are the key regions driving the growth of the dronedarone hydrochloride market?

A: North America and Europe are key markets, but emerging markets also offer potential for growth.

Q: What are the main challenges facing the dronedarone hydrochloride market?

A: The main challenges include safety concerns, regulatory scrutiny, and competition from other antiarrhythmic agents.

Sources

1. Global Dronedarone Hydrochloride Tablets Market Report 2024 - Cognitivemarketresearch.com
2. Dronedarone: An antiarrhythmic agent for the management of atrial fibrillation and atrial flutter - Managedhealthcareexecutive.com
3. Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular events - FDA.gov
4. Global Dronedarone Hydrochloride Market Insights, Forecast to 2029 - Giiresearch.com
5. Dronedarone in High-Risk Permanent Atrial Fibrillation - Acc.org