EPANED KIT Drug Patent Profile

Which patents cover Epaned Kit, and what generic alternatives are available?

Epaned Kit is a drug marketed by Azurity and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has five patent family members in five countries.

The generic ingredient in EPANED KIT 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 Kit

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

Summary for EPANED KIT

International Patents:	5
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	83
Patent Applications:	4,111
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPANED KIT
DailyMed Link:	EPANED KIT at DailyMed

Paragraph IV (Patent) Challenges for EPANED KIT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPANED KIT	Powder for Oral Solution	enalapril maleate	1 mg/mL	204308	1	2016-06-21

US Patents and Regulatory Information for EPANED KIT

EPANED KIT is protected by twelve 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
Azurity	EPANED KIT	enalapril maleate	FOR SOLUTION;ORAL	204308-001	Aug 13, 2013		DISCN	Yes	No
Azurity	EPANED KIT	enalapril maleate	FOR SOLUTION;ORAL	204308-001	Aug 13, 2013		DISCN	Yes	No			Y
Azurity	EPANED KIT	enalapril maleate	FOR SOLUTION;ORAL	204308-001	Aug 13, 2013		DISCN	Yes	No			Y

EU/EMA Drug Approvals for EPANED KIT

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 KIT

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

Country	Patent Number	Title	Estimated Expiration
Brazil	112015007592	composições de enalapril
World Intellectual Property Organization (WIPO)	2014055667
European Patent Office	2903690	COMPOSITIONS D'ÉNALAPRIL (ENALAPRIL COMPOSITIONS)
Spain	2770403
Canada	2887379	COMPOSITIONS D'ENALAPRIL (ENALAPRIL COMPOSITIONS)

EPANED KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Epaned Kit

Introduction to Epaned

Epaned, developed by Silvergate Pharmaceuticals, is a unique formulation of enalapril maleate in the form of a powder for oral solution. This medication is specifically designed to treat hypertension (high blood pressure), symptomatic heart failure, and asymptomatic left ventricular dysfunction in patients older than one month, including pediatric patients[1][4].

FDA Approval and Indications

The FDA approved Epaned for the treatment of hypertension in patients one month and older in August 2013. Subsequent approvals in September 2014 expanded its indications to include symptomatic heart failure and asymptomatic left ventricular dysfunction[1][4].

Market Need and Target Population

Epaned addresses a significant market need, particularly for pediatric patients and individuals who have difficulty swallowing tablets. The liquid formulation ensures accurate and consistent dosing, which was previously a challenge with compounded solutions or split tablets[2][4].

Unique Formulation and Benefits

Epaned's formulation offers several advantages over traditional enalapril tablets:

• Consistent Potency: The powder for oral solution ensures consistent potency in each dose, unlike compounded solutions which may vary in efficacy.
• Ease of Administration: The kit is simple to prepare and does not require any tools or steps, making it user-friendly for both patients and caregivers.
• Stability: The constituted solution is stable for 60 days, reducing the need for frequent preparation[1][2].

Market Availability and Accessibility

Epaned is widely available through an extensive network of pharmacies and qualified mail order services. It is covered by most private insurance plans and state Medicaid programs, ensuring affordability and accessibility for patients. Additional support includes co-pay assistance and patient aid programs for qualifying patients[1][4].

Financial Considerations and Payer Dynamics

Price Elasticity and Restrictions

In the pharmaceutical market, price elasticity plays a crucial role in determining payer restrictions. For Epaned, given its unique formulation and the specific patient population it serves, payers are likely to view it as a necessary medication rather than a discretionary one. This could make its demand relatively price inelastic, especially since it addresses unmet needs in pediatric and difficult-to-treat populations[3].

Reimbursement and Coverage

Epaned's coverage by most commercial payers and Medicaid programs indicates a favorable reimbursement landscape. This widespread coverage helps in maintaining a stable financial trajectory for the drug, as it ensures that patients can access the medication without significant financial barriers[1][4].

Competitive Landscape

The approval of Epaned has also led to legal disputes, such as the case between Azurity Pharm and BionPharm, which highlights the competitive nature of the enalapril market. Azurity's efforts to maintain a monopoly in enalapril liquids through litigation underscore the financial stakes involved in this market segment[5].

Market Impact and Growth Potential

Unmet Need and Patient Population

Epaned's approval has filled a critical gap in the treatment of hypertension and heart failure, especially in pediatric patients. This unmet need translates into a significant market opportunity, as it provides a reliable and consistent treatment option for a population that was previously underserved[1][4].

Clinical Superiority

The clinical superiority of Epaned over compounded solutions, particularly in terms of dosing accuracy and stability, positions it favorably in the market. This superiority can drive market share and revenue growth as healthcare providers and patients opt for the FDA-approved formulation over less reliable alternatives[2].

Financial Trajectory

Given the factors mentioned above, the financial trajectory for Epaned is likely to be positive:

• Stable Revenue Stream: Widespread coverage and reimbursement ensure a stable revenue stream.
• Market Growth: Addressing unmet needs in pediatric and difficult-to-treat populations can drive market growth.
• Competitive Advantage: The unique formulation and clinical superiority of Epaned provide a competitive edge, potentially leading to increased market share.

Challenges and Opportunities

Regulatory and Legal Challenges

The pharmaceutical industry is heavily regulated, and legal disputes, such as those involving generic competition, can impact the financial trajectory of Epaned. However, Silvergate Pharmaceuticals' commitment to innovation and compliance with FDA regulations helps mitigate these risks[1][5].

Market Expansion

There is potential for market expansion through increased awareness and adoption among healthcare providers and patients. Educational campaigns and clinical trials demonstrating the efficacy and safety of Epaned can further solidify its position in the market.

Key Takeaways

• Unique Formulation: Epaned's powder for oral solution offers consistent potency and ease of administration.
• Market Need: Addresses unmet needs in pediatric and difficult-to-treat populations.
• Financial Stability: Widespread coverage and reimbursement ensure a stable revenue stream.
• Competitive Advantage: Clinical superiority over compounded solutions.
• Growth Potential: Significant market opportunity due to unmet needs and potential for increased adoption.

FAQs

Q: What are the approved indications for Epaned? A: Epaned is approved for the treatment of hypertension, symptomatic heart failure, and asymptomatic left ventricular dysfunction in patients older than one month[1].

Q: How does Epaned differ from traditional enalapril tablets? A: Epaned is a powder for oral solution, ensuring consistent potency and ease of administration, unlike traditional tablets which may require pill splitting and have variable efficacy[2].

Q: Is Epaned covered by insurance? A: Yes, Epaned is covered by most private insurance plans and state Medicaid programs, making it accessible to a wide range of patients[1][4].

Q: What are the benefits of Epaned for pediatric patients? A: Epaned provides accurate and consistent dosing, which is particularly beneficial for pediatric patients who previously relied on adjusted adult doses or compounded solutions[4].

Q: How does the competitive landscape affect Epaned's market position? A: The competitive landscape, including legal disputes over generic competition, highlights the financial stakes but also underscores Epaned's unique value proposition and clinical superiority[5].

Sources

1. Silvergate Pharmaceuticals Release: FDA Approves 2 New Indications for Epaned.
2. FDA Document: 204308Orig1s000 - accessdata.fda.gov.
3. PharmExec: Price Elasticity and Inelasticity of Restriction.
4. FiercePharma: FDA Approves Epaned, a Liquid Form of Enalapril for Children and Adults.
5. Casetext: Azurity Pharm. v. BionPharm.