EPANED Drug Patent Profile

When do Epaned patents expire, and when can generic versions of Epaned launch?

Epaned is a drug marketed by Azurity and is included in two NDAs. There are thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has three patent family members in three countries.

The generic ingredient in EPANED is enalapril maleate. There are twenty-seven drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the enalapril maleate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Epaned

A generic version of EPANED was approved as enalapril maleate by HERITAGE PHARMA on August 22^nd, 2000.

Summary for EPANED

International Patents:	3
US Patents:	9
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	83
Patent Applications:	3,999
Drug Prices:	Drug price information for EPANED
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPANED
What excipients (inactive ingredients) are in EPANED?	EPANED excipients list
DailyMed Link:	EPANED at DailyMed

See drug prices for EPANED

Pharmacology for EPANED

Drug Class	Angiotensin Converting Enzyme Inhibitor
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors
Physiological Effect	Decreased Blood Pressure

Paragraph IV (Patent) Challenges for EPANED

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPANED	Oral Solution	enalapril maleate	1 mg/mL	208686	1	2018-08-31

US Patents and Regulatory Information for EPANED

EPANED is protected by seventeen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	EPANED KIT	enalapril maleate	FOR SOLUTION;ORAL	204308-001	Aug 13, 2013		DISCN	Yes	No	8,568,747		Y
Azurity	EPANED KIT	enalapril maleate	FOR SOLUTION;ORAL	204308-001	Aug 13, 2013		DISCN	Yes	No	9,855,214		Y
Azurity	EPANED	enalapril maleate	SOLUTION;ORAL	208686-001	Sep 20, 2016	AB	RX	Yes	Yes	9,808,442
Azurity	EPANED KIT	enalapril maleate	FOR SOLUTION;ORAL	204308-001	Aug 13, 2013		DISCN	Yes	No	8,778,366
Azurity	EPANED	enalapril maleate	SOLUTION;ORAL	208686-001	Sep 20, 2016	AB	RX	Yes	Yes	10,154,987
Azurity	EPANED	enalapril maleate	SOLUTION;ORAL	208686-001	Sep 20, 2016	AB	RX	Yes	Yes	9,669,008		Y

EU/EMA Drug Approvals for EPANED

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Proveca Pharma Limited	Aqumeldi	Enalapril maleate	EMEA/H/C/005731 Treatment of heart failure.	Authorised	no	no	no	2023-11-15

International Patents for EPANED

See the table below for patents covering EPANED around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017161339
Brazil	112018068960	formulações de enalapril
European Patent Office	3429581	FORMULATIONS D'ÉNALAPRIL (ENALAPRIL FORMULATIONS)

EPANED Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Epaned

Introduction

Epaned, an angiotensin-converting enzyme (ACE) inhibitor, is a crucial medication in the treatment of hypertension, symptomatic heart failure, and asymptomatic left ventricular dysfunction. This article delves into the market dynamics and financial trajectory of Epaned, highlighting its current market position, growth prospects, and the factors influencing its demand.

Market Size and Growth Prospects

The global congestive heart failure (CHF) drugs market, within which Epaned operates, was valued at USD 7.69 billion in 2023 and is projected to grow at a CAGR of 14.6% from 2024 to 2030[1].

Segment Dominance

ACE inhibitors, the class of drugs to which Epaned belongs, held the largest share of 28.6% in the CHF drugs market in 2023. This dominance is due to ACE inhibitors being the first treatment choice for CHF patients, highlighting Epaned's significant market presence[1].

Indications and Usage

Epaned is indicated for the treatment of hypertension, symptomatic heart failure, and asymptomatic left ventricular dysfunction. Its efficacy in lowering blood pressure, increasing survival, and reducing hospitalization rates for heart failure patients makes it a preferred choice among healthcare providers[5].

Pricing and Affordability

The cost of Epaned can be substantial, with a supply of 150 milliliters of the oral liquid formulation costing around $665 for cash-paying customers. However, the availability of discount cards and patient assistance programs can significantly reduce the cost, making it more accessible to patients[2].

FDA Approvals and Expanding Indications

Epaned has received FDA approvals for multiple indications, including hypertension, symptomatic heart failure, and asymptomatic left ventricular dysfunction. These approvals have expanded its market reach and patient base, contributing to its financial growth[4].

Distribution Channels

Hospital pharmacies dominate the market for CHF drugs, including Epaned, with a 55.6% share in 2023. However, retail pharmacies are expected to grow at a CAGR of 15.3% over the forecast period, driven by the increasing shift towards outpatient CHF management. This shift is likely to impact Epaned's distribution and sales channels positively[1].

Geographic Market

North America, particularly the U.S., holds the largest share of the CHF drugs market, driven by a large geriatric population, high disease burden, and extensive healthcare coverage. The U.S. market for CHF drugs, including Epaned, is expected to continue growing due to these factors[1].

Competitive Landscape

The introduction of generic versions of Epaned, although not yet commercially available, could potentially impact its market share. However, the brand's strong reputation and the FDA's approval of new indications have helped maintain its market position. The competition effect from generic entries is expected to reduce prices and increase market accessibility, but it may also lead to increased overall demand for ACE inhibitors[3].

Research and Development

Continuous research and development in the CHF drugs market are leading to the introduction of new and more effective treatments. While Epaned remains a cornerstone in CHF management, the development of long-acting injectable formulations and other innovative treatments could influence its market dynamics. However, Epaned's proven efficacy and safety profile ensure its continued relevance[1].

Healthcare Expenditures and Coverage

Rising healthcare expenditures and expanding healthcare coverage in developing countries are enabling greater access to CHF treatments, including Epaned. This increased access is a significant driver of the drug's financial trajectory, as more patients can now afford and access these medications[1].

Patient Awareness and Early Detection

Growing awareness about heart health and the importance of early detection and treatment is further fueling the demand for CHF drugs like Epaned. Early detection and treatment can lead to better patient outcomes, which in turn drives the demand for effective medications[1].

Financial Impact of Generic Entries

The approval of generic versions of Epaned could reduce its market share but also lower the overall cost of treatment, making it more accessible to a wider patient base. Studies have shown that generic entries can reduce annual consumer expenditures significantly, which could indirectly benefit the market by increasing the overall volume of drugs sold[3].

Key Takeaways

• Market Growth: The CHF drugs market, including Epaned, is projected to grow at a CAGR of 14.6% from 2024 to 2030.
• Segment Dominance: ACE inhibitors, like Epaned, hold a significant market share due to their efficacy in treating CHF.
• Pricing and Affordability: While Epaned can be costly, discount programs and patient assistance can make it more affordable.
• FDA Approvals: Multiple FDA approvals have expanded Epaned's indications and market reach.
• Distribution Channels: Hospital pharmacies currently dominate, but retail pharmacies are expected to grow significantly.
• Geographic Market: North America, particularly the U.S., is a key market for Epaned due to high disease burden and extensive healthcare coverage.

FAQs

What are the primary indications for Epaned?

Epaned is indicated for the treatment of hypertension, symptomatic heart failure, and asymptomatic left ventricular dysfunction[5].

How does the cost of Epaned compare to other CHF medications?

The cost of Epaned can be substantial, but it is comparable to other ACE inhibitors. Discount cards and patient assistance programs can reduce the cost significantly[2].

What is the impact of generic entries on Epaned's market share?

Generic entries could reduce Epaned's market share but are expected to lower overall treatment costs, making CHF medications more accessible to a wider patient base[3].

Which distribution channels are most significant for Epaned?

Hospital pharmacies currently dominate the market, but retail pharmacies are expected to grow significantly as CHF management shifts towards outpatient settings[1].

How does the geographic market influence Epaned's sales?

North America, particularly the U.S., is a key market for Epaned due to a large geriatric population, high disease burden, and extensive healthcare coverage[1].

Sources

1. Grand View Research: Congestive Heart Failure Drugs Market Size Report, 2030.
2. Drugs.com: Epaned Prices, Coupons, Copay Cards & Patient Assistance.
3. National Bureau of Economic Research: Quantifying 21st Century Opportunity Costs of FDA Regulation.
4. Biospace: Silvergate Pharmaceuticals Release: FDA Approves 2 New Indications for Epaned.
5. Epaned.com: EPANED (enalapril maleate) Oral Solution Prescribing Information.