Eplerenone - Generic Drug Details

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

Eplerenone is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Annora Pharma, Breckenridge, Chartwell Rx, Prasco, Rising, Sandoz, Slate Run Pharma, Westminster Pharms, and Upjohn, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for eplerenone. Fourteen suppliers are listed for this compound.

Summary for eplerenone

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	128
Patent Applications:	5,437
Drug Prices:	Drug price trends for eplerenone
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for eplerenone
What excipients (inactive ingredients) are in eplerenone?	eplerenone excipients list
DailyMed Link:	eplerenone at DailyMed

See drug prices for eplerenone

Recent Clinical Trials for eplerenone

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

Sponsor	Phase
Assiut University	Phase 4
Vifor Pharma	Phase 3
Mario Negri Institute for Pharmacological Research	Phase 3

See all eplerenone clinical trials

Pharmacology for eplerenone

Drug Class	Aldosterone Antagonist
Mechanism of Action	Aldosterone Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for eplerenone

C03DA	Aldosterone antagonists
C03D	ALDOSTERONE ANTAGONISTS AND OTHER POTASSIUM-SPARING AGENTS
C03	DIURETICS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for EPLERENONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INSPRA	Injection	eplerenone	0.75 mg/mL, 100 mL vial	021437	1	2009-06-05
INSPRA	Tablets	eplerenone	25 mg and 50 mg	021437	2	2006-09-27

US Patents and Regulatory Information for eplerenone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Slate Run Pharma	EPLERENONE	eplerenone	TABLET;ORAL	212765-001	Aug 10, 2020	AB	RX	No	No
Sandoz	EPLERENONE	eplerenone	TABLET;ORAL	078510-002	Aug 1, 2008	AB	RX	No	No
Annora Pharma	EPLERENONE	eplerenone	TABLET;ORAL	213812-002	Jun 2, 2023	AB	RX	No	No
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-003	Sep 27, 2002		DISCN	No	No
Sandoz	EPLERENONE	eplerenone	TABLET;ORAL	078510-001	Aug 1, 2008	AB	RX	No	No
Westminster Pharms	EPLERENONE	eplerenone	TABLET;ORAL	207842-002	Oct 25, 2021	AB	RX	No	No

Expired US Patents for eplerenone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-003	Sep 27, 2002
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-002	Sep 27, 2002
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-002	Sep 27, 2002
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-003	Sep 27, 2002
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-003	Sep 27, 2002
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-002	Sep 27, 2002

Eplerenone Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Eplerenone

Introduction to Eplerenone

Eplerenone, marketed under the brand name Inspra, is an oral aldosterone receptor blocker used primarily to treat hypertension and heart failure in adults. It is particularly effective in patients with left ventricular systolic dysfunction and heart failure after acute myocardial infarction[2][4].

Market Size and Growth Projections

The global eplerenone market is anticipated to experience significant growth over the coming years. As of 2023, the market size was valued at USD 1.2 billion and is projected to reach USD 1.7 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.5% from 2024 to 2031[4].

Key Drivers of Market Growth

Several factors are driving the growth of the eplerenone market:

Increasing Prevalence of Cardiovascular Diseases

The rising incidence of cardiovascular diseases such as hypertension and heart failure is a major driver. As the global population ages and lifestyle factors contribute to higher rates of these conditions, the demand for effective treatments like eplerenone increases[4].

Advances in Medical Research

Continuous advancements in medical research and the development of new formulations and uses for eplerenone are enhancing its therapeutic potential. This includes improved understanding and application of selective aldosterone antagonists[4].

Expanding Healthcare Infrastructure

The expansion of healthcare infrastructure and improved accessibility to medications are also significant drivers. Enhanced public awareness of the benefits of targeted medicines and supportive insurance coverage further stimulate market demand[4].

Market Segmentation

The eplerenone market is segmented based on several criteria:

Type

The market is categorized into oral tablets, extended-release tablets, and combination tablets. Each type serves different patient needs and preferences, contributing to the overall market growth[4].

Application

Eplerenone is used primarily for hypertension, heart failure, and post-myocardial infarction therapy. The efficacy of eplerenone in these applications is a key factor in its market success[4].

Geographical Regions

The market is analyzed across various geographical regions including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region presents unique market dynamics and growth opportunities[1][4].

Competitive Landscape

The eplerenone market is characterized by a competitive landscape with several major players. These companies are involved in continuous innovation, business expansions, and strategic investments to maintain market share and capitalize on growth opportunities[1].

Cost and Pricing Factors

The cost of eplerenone can vary based on several factors:

Treatment Plan and Insurance Coverage

The price a patient pays for eplerenone depends on their treatment plan, insurance coverage, and the pharmacy used. Long-term treatment plans, such as a 90-day supply, can help reduce costs[2].

Average Wholesale Price

In clinical studies, eplerenone has been priced at an average wholesale price of $3.60 per day. This pricing is crucial for cost-effectiveness analyses and patient affordability[3].

Cost-Effectiveness and Clinical Outcomes

Studies have shown that eplerenone is cost-effective in treating heart failure and hypertension. For instance, the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS) demonstrated that eplerenone reduces mortality and is cost-effective in increasing life-years. The incremental cost-effectiveness ratio ranged from $10,402 to $21,876 per life-year gained, depending on the data source used[3].

Market Challenges

Despite the positive outlook, the eplerenone market faces several challenges:

Economic Fluctuations

Economic factors such as recessions, inflation, and currency exchange rate changes can impact consumer spending and investment, affecting sales and revenue[1].

Regulatory Changes

Compliance with new regulations can be costly and time-consuming, impacting operations and profitability. Companies must navigate these changes to maintain market position[1].

Technological Advancements

Rapid technological advancements require companies to invest in the latest innovations, which can be financially straining and risk obsolescence if not managed properly[1].

Competitive Pressures

Intense competition necessitates continuous innovation and improvement, leading to potential price wars, reduced profit margins, and increased marketing expenditures[1].

Regional Market Analysis

The global eplerenone market is analyzed across various regions, each with its own market dynamics:

North America

This region is a significant market due to high healthcare spending and advanced medical infrastructure. The US, Canada, and Mexico are key countries driving growth in this region[1].

Europe

Europe is another major market, with countries like the UK, Germany, France, and Italy contributing to the regional growth. Regulatory environments and healthcare policies play a crucial role here[1].

Asia-Pacific

The Asia-Pacific region, including countries like China, Japan, and South Korea, is experiencing rapid growth due to increasing healthcare needs and improving economic conditions[1].

Key Takeaways

• The global eplerenone market is expected to grow significantly, driven by increasing prevalence of cardiovascular diseases and advances in medical research.
• Market segmentation by type, application, and geographical region highlights diverse growth opportunities.
• Cost-effectiveness studies show eplerenone to be a valuable treatment option, despite challenges such as economic fluctuations and regulatory changes.
• Continuous innovation and strategic investments are crucial for companies to maintain market share.

Frequently Asked Questions (FAQs)

1. What is eplerenone used for? Eplerenone is used to treat hypertension in adults and heart failure in patients with reduced ejection fraction after a heart attack. It is also approved for post-myocardial infarction therapy[2].

2. How does the cost of eplerenone vary? The cost of eplerenone can vary based on factors such as treatment plan, insurance coverage, and the pharmacy used. Long-term supply options can help reduce costs[2].

3. Is eplerenone cost-effective? Yes, studies have shown that eplerenone is cost-effective in treating heart failure and hypertension, with incremental cost-effectiveness ratios indicating it is a valuable treatment option[3].

4. What are the major drivers of the eplerenone market? The major drivers include the increasing prevalence of cardiovascular diseases, advances in medical research, and the expansion of healthcare infrastructure[4].

5. What challenges does the eplerenone market face? The market faces challenges such as economic fluctuations, regulatory changes, technological advancements, and intense competitive pressures[1].

Cited Sources:

1. Future Market Report: Eplerenone Market Size, Share, Growth | CAGR Forecast 2032
2. Medical News Today: Eplerenone cost 2024: Coupons and more
3. PubMed: Cost-effectiveness of eplerenone compared with placebo in patients ...
4. Market Research Intellect: Eplerenone Market Size and Projections
5. FDA: Application Type NDA Submission Number 21-437 S005 ... - FDA