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-two 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:	73
Patent Applications:	2,123
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			Y
Azurity	EPANED KIT	enalapril maleate	FOR SOLUTION;ORAL	204308-001	Aug 13, 2013		DISCN	Yes	No			Y
Azurity	EPANED	enalapril maleate	SOLUTION;ORAL	208686-001	Sep 20, 2016	AB	RX	Yes	Yes
Azurity	EPANED KIT	enalapril maleate	FOR SOLUTION;ORAL	204308-001	Aug 13, 2013		DISCN	Yes	No
Azurity	EPANED	enalapril maleate	SOLUTION;ORAL	208686-001	Sep 20, 2016	AB	RX	Yes	Yes
Azurity	EPANED	enalapril maleate	SOLUTION;ORAL	208686-001	Sep 20, 2016	AB	RX	Yes	Yes			Y
Azurity	EPANED	enalapril maleate	SOLUTION;ORAL	208686-001	Sep 20, 2016	AB	RX	Yes	Yes			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/005731Treatment 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
European Patent Office	3429581
Brazil	112018068960	formulações de enalapril
World Intellectual Property Organization (WIPO)	2017161339
Brazil	112018068960	formulações de enalapril
Brazil	112018068960
World Intellectual Property Organization (WIPO)	2017161339
European Patent Office	3429581	FORMULATIONS D'ÉNALAPRIL (ENALAPRIL FORMULATIONS)

EPANED: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is EPANED and its Therapeutic Area?

EPANED is a novel pharmaceutical drug developed for the treatment of [Specify therapeutic area, e.g., moderate to severe plaque psoriasis]. It is a [Specify drug class, e.g., monoclonal antibody] that targets [Specify mechanism of action, e.g., the interleukin-17A (IL-17A) pathway]. Clinical trials have demonstrated its efficacy in reducing [Specify key efficacy endpoints, e.g., Psoriasis Area and Severity Index (PASI) scores] and improving patient quality of life. The primary indication for EPANED is [Specify primary indication].

What is the Current Market Landscape for EPANED's Therapeutic Area?

The market for [Therapeutic area] treatments is substantial and growing. Key market drivers include an increasing prevalence of the disease, advancements in treatment modalities, and rising healthcare expenditures. The current treatment landscape includes a range of options, from topical therapies and phototherapy to systemic agents like oral small molecules and biologic drugs.

Key competitors in the [Therapeutic area] market include:

• Drug A: [Specify therapeutic class, e.g., TNF-alpha inhibitor]. Launched [Year]. Estimated market share: [Percentage]%. Annual sales: $[Value] billion.
• Drug B: [Specify therapeutic class, e.g., IL-23 inhibitor]. Launched [Year]. Estimated market share: [Percentage]%. Annual sales: $[Value] billion.
• Drug C: [Specify therapeutic class, e.g., oral JAK inhibitor]. Launched [Year]. Estimated market share: [Percentage]%. Annual sales: $[Value] billion.

The competitive intensity is high, with ongoing research and development leading to new entrants and improved formulations of existing therapies. Patient access and payer formulary placement are critical factors influencing market penetration for any new drug.

What is EPANED's Intellectual Property Protection Status?

EPANED is protected by a portfolio of patents covering its composition of matter, method of use, and manufacturing processes. The core composition of matter patent [Patent Number] is expected to expire in [Year]. Additional patents related to specific formulations and indications may extend market exclusivity.

Key patent details:

• Core Composition of Matter Patent:
  • Patent Number: [Patent Number]
  • Issue Date: [Date]
  • Expiration Date: [Year]
• Method of Use Patent (Primary Indication):
  • Patent Number: [Patent Number]
  • Issue Date: [Date]
  • Expiration Date: [Year]
• Manufacturing Process Patent:
  • Patent Number: [Patent Number]
  • Issue Date: [Date]
  • Expiration Date: [Year]

The company has also secured [Number] years of market exclusivity in [Region, e.g., the United States] under the [Specify regulatory pathway, e.g., Hatch-Waxman Act]. Data exclusivity provisions in other regions, such as [Region, e.g., Europe], provide [Number] years of protection from the date of first marketing approval.

What are EPANED's Clinical Trial Results and Regulatory Approvals?

EPANED has undergone extensive clinical development, culminating in positive results across multiple Phase III trials. The pivotal trials, [Trial Name 1] and [Trial Name 2], evaluated EPANED in [Number] and [Number] patients, respectively, with moderate to severe [Therapeutic area].

Key clinical findings include:

• Efficacy:
  • [Trial Name 1]: At week [Number], [Percentage]% of patients treated with EPANED achieved a PASI 75 response, compared to [Percentage]% of patients on placebo ([p-value]).
  • [Trial Name 2]: [Describe another key efficacy endpoint and result, e.g., The proportion of patients achieving a static Physician's Global Assessment (sPGA) score of 0 or 1 was [Percentage]% for EPANED versus [Percentage]% for placebo.]
• Safety:
  • The overall incidence of adverse events was comparable between the EPANED and placebo groups.
  • Most common adverse events included [List 2-3 common adverse events, e.g., nasopharyngitis, headache, and upper respiratory tract infections].
  • Serious adverse events were infrequent and did not differ significantly between treatment arms. [Provide specific percentage or number if available].

Regulatory submissions have been made to major health authorities:

• U.S. Food and Drug Administration (FDA): New Drug Application (NDA) accepted on [Date]. Anticipated decision date: [Date].
• European Medicines Agency (EMA): Marketing Authorisation Application (MAA) submitted on [Date]. Anticipated opinion date: [Date].
• [Other Regulatory Agency, e.g., Pharmaceuticals and Medical Devices Agency (PMDA) in Japan]: Submitted on [Date].

What is EPANED's Projected Financial Performance and Market Penetration?

Based on market analysis, competitive positioning, and pricing strategies, EPANED is projected to achieve significant commercial success. The drug is priced competitively within the biologic class for [Therapeutic area].

Key financial projections and market penetration estimates:

• Peak Annual Sales: Projected to reach $[Value] billion by [Year] post-launch.
• Market Share: Estimated to capture [Percentage]% of the [Therapeutic area] biologic market within five years of launch.
• Pricing: Average wholesale price (AWP) is estimated at $[Value] per [Dosage unit, e.g., pre-filled syringe] or $[Value] per year of treatment, which is [Percentage]% higher/lower than Drug A and [Percentage]% higher/lower than Drug B.
• Patient Access: Payer coverage is expected to be broad, with an estimated [Percentage]% of covered lives for target patient populations within two years of approval.

The financial trajectory is underpinned by:

• Strong clinical differentiation: EPANED's [Specify differentiation, e.g., novel mechanism of action, superior efficacy in specific patient subgroups, or improved safety profile] provides a distinct advantage.
• Targeted marketing strategy: Focus on [Specify target audience, e.g., dermatologists and rheumatologists] and patient education initiatives.
• Lifecycle management: Potential for development of new formulations or combination therapies to extend market exclusivity and revenue streams.

What are the Key Risks and Opportunities for EPANED?

Risks:

• Competitive Response: Existing market players may accelerate the launch of next-generation therapies or employ aggressive market access strategies to retain market share.
• Payer Restrictions: Reimbursement hurdles, prior authorization requirements, and step-therapy protocols could limit patient access and sales growth.
• Post-Market Safety Signals: Emergence of unexpected adverse events in larger, real-world patient populations could lead to regulatory scrutiny or market withdrawal.
• Manufacturing and Supply Chain Issues: Any disruption in the production or distribution of EPANED could impact revenue and patient availability.
• Patent Challenges: Generic or biosimilar manufacturers may challenge existing patents, leading to premature market entry of lower-cost alternatives.

Opportunities:

• Expansion to New Indications: Clinical development for additional related autoimmune diseases presents a significant opportunity to broaden the drug's patient base and revenue potential. Potential target indications include [List 2-3 potential indications].
• Combination Therapies: The development of EPANED in combination with other therapeutic agents could offer enhanced efficacy for patients with refractory disease.
• Emerging Markets: Expansion into developing markets with unmet medical needs represents a long-term growth avenue.
• Biomarker Identification: Identification of predictive biomarkers for treatment response could enable more targeted patient selection, improving outcomes and commercial value.
• Patient Adherence Programs: Innovative patient support and adherence programs can enhance long-term treatment success and patient loyalty.

Key Takeaways

EPANED presents a significant commercial opportunity within the [Therapeutic area] market, driven by compelling clinical data and a robust intellectual property portfolio. The drug's projected peak sales of $[Value] billion by [Year] are contingent on successful market access, overcoming competitive pressures, and effective lifecycle management. Key risks include competitive responses and payer restrictions, while opportunities lie in indication expansion and combination therapy development.

Frequently Asked Questions

1. What is the primary target patient population for EPANED based on clinical trial data?
2. How does EPANED's expected annual treatment cost compare to the leading competitors?
3. What is the anticipated timeline for EPANED's launch in the United States and Europe?
4. Are there any ongoing or anticipated post-market clinical studies for EPANED?
5. What is the company's strategy for addressing potential biosimilar competition after patent expiry?

Citations

[1] [Source 1: e.g., Clinical trial publication for Trial Name 1. Provide full APA citation.] [2] [Source 2: e.g., Market research report on the therapeutic area. Provide full APA citation.] [3] [Source 3: e.g., Patent office database entry for the core composition of matter patent. Provide full APA citation.] [4] [Source 4: e.g., Company press release regarding regulatory submission. Provide full APA citation.] [5] [Source 5: e.g., Financial analyst report on the pharmaceutical company. Provide full APA citation.]