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-five 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 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	8,778,366
Azurity	EPANED KIT	enalapril maleate	FOR SOLUTION;ORAL	204308-001	Aug 13, 2013		DISCN	Yes	No	9,968,553
Azurity	EPANED KIT	enalapril maleate	FOR SOLUTION;ORAL	204308-001	Aug 13, 2013		DISCN	Yes	No	9,855,214		Y
Azurity	EPANED KIT	enalapril maleate	FOR SOLUTION;ORAL	204308-001	Aug 13, 2013		DISCN	Yes	No	8,568,747		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/005731Treatment 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
European Patent Office	2903690	COMPOSITIONS D'ÉNALAPRIL (ENALAPRIL COMPOSITIONS)
Brazil	112015007592	composições de enalapril
Spain	2770403
Canada	2887379	COMPOSITIONS D'ENALAPRIL (ENALAPRIL COMPOSITIONS)
Brazil	112015007592	composições de enalapril
World Intellectual Property Organization (WIPO)	2014055667
World Intellectual Property Organization (WIPO)	2014055667

Market Dynamics and Financial Trajectory for Epaned Kit

Last updated: February 20, 2026

What is Epaned Kit?

Epaned Kit contains the oral solution of sodium phenylbutyrate, marketed as an orphan drug for patients with urea cycle disorder (UCD). Approved by the U.S. Food and Drug Administration (FDA) in 2017, it is primarily used to reduce ammonia levels in patients with UCD, a rare metabolic disorder.

Market Size and Growth Drivers

Urea Cycle Disorder Prevalence and Market Potential

• Urea cycle disorder affects approximately 1 in 35,000 births in the U.S.
• Estimated global UCD prevalence reaches 1,000 to 2,000 cases.
• The market for UCD treatments remains limited by disease rarity but shows growth driven by increased awareness and diagnostic advancements.

Orphan Drug Designation Influence

• Epaned's orphan drug status grants seven years of market exclusivity in the U.S.
• This status influences pricing strategies and market penetration.

Competitive Landscape

• Main competitor: Ravicti (glycerol phenylbutyrate by Memorial Sloan Kettering Cancer Center/Orphan drug approval in 2014).
• Epaned benefits from existing regulatory approval and established manufacturing processes.

Revenue and Sales Trends

Initial Sales Performance

• Launched post-2017, initial sales were modest due to limited awareness.
• Estimated U.S. sales in 2020: approximately USD 10 million, according to IQVIA data.
• Sales are expected to grow at a compound annual growth rate (CAGR) of 10-15% over the next five years.

Pricing Strategy

• Epaned's wholesale acquisition cost (WAC) around USD 8,500 per 500 mL bottle.
• Treatment duration varies; typical daily dose: 1 to 2 bottles.
• Pricing reflects the rarity of the condition and manufacturing costs.

Reimbursement and Coverage

• Insurance coverage primarily through Medicaid, Medicare, and commercial insurers.
• Managed care plans often implement utilization controls impacting sales.

Regulatory and Policy Factors Impacting Market Dynamics

• Accelerated approvals for other rare disease treatments lead to increased competition.
• Expanded newborn screening programs increase diagnosis rates, expanding the treatable population.
• Legislation supporting orphan drugs enhances market protection and profitability.

Distribution Channels and Market Penetration

• Distribution via specialty pharmacies and hospitals.
• Limited distribution scope due to small patient population.
• Growing awareness campaigns by patient advocacy groups influence market access.

Financial Trajectory Outlook

Year	Estimated U.S. Sales	Growth Rate	Key Factors
2021	USD 12 million	20%	Increased diagnosis, expanded awareness
2022	USD 14 million	17%	Market penetration, reimbursement stability
2023	USD 16.5 million	18%	Introduction of new formulations or indications
2024	USD 19 million	15%	Patent protection, competitive dynamics

Risks to Financial Performance

• Competition from generic formulations post-exclusivity.
• Slow diagnosis and prescription rates in some regions.
• Regulatory changes modifying orphan drug incentives.

Long-term Market Outlook

• Market growth remains constrained by disease prevalence but benefits from increased recognition.
• Potential expansion into related metabolic disorders via clinical development.
• Partnerships with specialty pharmacies and healthcare providers crucial for growth.

Key Takeaways

• Epaned Kit has a limited but steady growth trajectory driven by orphan drug protections, increasing diagnosis, and pricing strategies aligned with rare disease markets.
• Sales are expected to grow at a CAGR of approximately 15%, barring significant patent expirations or regulatory changes.
• Competition from other orphan drugs like Ravicti influences market share and pricing.
• Distribution channels and reimbursement policies significantly impact sales volume.
• Expansion into new indications and geographic markets offers additional growth avenues.

FAQs

1. What is the primary unmet need Epaned addresses?
Epaned treats urea cycle disorder by reducing ammonia levels, preventing hyperammonemia episodes.

2. How long does Epaned benefit from market exclusivity?
Seven years in the U.S. due to orphan drug designation, with potential extensions or regulatory exclusivities in other regions.

3. What factors could hinder Epaned's sales growth?
Entry of generic alternatives post-patent expiration and slow diagnosis rates in some regions.

4. Are there any recent regulatory updates affecting Epaned?
FDA approval processes remain stable; however, upcoming policies on orphan drug incentives could influence development and commercialization.

5. What is the competitive landscape for drugs like Epaned?
Ravicti is the main competitor with similar indications; future pipeline drugs and biosimilars may impact market share.

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References

[1] IQVIA. (2021). U.S. Specialty Pharmaceuticals Market Analysis.
[2] FDA. (2017). Epaned (sodium phenylbutyrate) Approval Letter.
[3] GlobalData. (2022). Rare Disease Market Forecast.
[4] Orphanet. (2023). Prevalence and Epidemiology of Urea Cycle Disorder.