Enalapril maleate - Generic Drug Details

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

Enalapril maleate is the generic ingredient in seven branded drugs marketed by Azurity, Alkem Labs Ltd, Amneal, Annora Pharma, Aurobindo Pharma, Bionpharma, Aiping Pharm Inc, Apothecon, Aurobindo Pharma Usa, Chartwell Rx, Heritage Pharma, Ivax Sub Teva Pharms, Krka Dd Novo Mesto, Mylan, Prinston Inc, Regcon Holdings, Sandoz Inc, Senores Pharms, Sun Pharm Inds Ltd, Taro, Unique Pharm, Watson Labs, Bausch, Astrazeneca, Cosette, Mpp Pharma, Rising, and Taro Pharm Inds, and is included in thirty-five NDAs. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Enalapril maleate has eight patent family members in five countries.

There are eighteen drug master file entries for enalapril maleate. Thirty-five suppliers are listed for this compound.

Summary for enalapril maleate

International Patents:	8
US Patents:	13
Tradenames:	7
Applicants:	28
NDAs:	35
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	16
Patent Applications:	6,772
Drug Prices:	Drug price trends for enalapril maleate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for enalapril maleate
What excipients (inactive ingredients) are in enalapril maleate?	enalapril maleate excipients list
DailyMed Link:	enalapril maleate at DailyMed

See drug prices for enalapril maleate

See drug sales revenues for enalapril maleate

Recent Clinical Trials for enalapril maleate

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

Sponsor	Phase
Manchester University NHS Foundation Trust	Phase 2
Newcastle-upon-Tyne Hospitals NHS Trust	Phase 3
South Tees Hospitals NHS Foundation Trust	Phase 3

See all enalapril maleate clinical trials

Pharmacology for enalapril maleate

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

Medical Subject Heading (MeSH) Categories for enalapril maleate

Angiotensin-Converting Enzyme Inhibitors

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for enalapril maleate

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for ENALAPRIL MALEATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPANED	Oral Solution	enalapril maleate	1 mg/mL	208686	1	2018-08-31
EPANED KIT	Powder for Oral Solution	enalapril maleate	1 mg/mL	204308	1	2016-06-21

US Patents and Regulatory Information for enalapril maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Heritage Pharma	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075479-004	Aug 22, 2000	AB	RX	No	No
Ivax Sub Teva Pharms	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075482-004	Aug 22, 2000		DISCN	No	No
Apothecon	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075583-002	Aug 22, 2000		DISCN	No	No
Sun Pharm Inds Ltd	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075556-002	Aug 22, 2000		DISCN	No	No

Expired US Patents for enalapril maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-005	Jul 26, 1988
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-001	Dec 24, 1985
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-003	Dec 24, 1985
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-002	Dec 24, 1985

EU/EMA Drug Approvals for enalapril maleate

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 enalapril maleate

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017161339
Brazil	112015007592	composições de enalapril
Brazil	112018068960	formulações de enalapril
Spain	2770403

Market Dynamics and Financial Trajectory for Enalapril Maleate

Last updated: February 19, 2026

What Are the Current Market Conditions for Enalapril Maleate?

Enalapril maleate is an angiotensin-converting enzyme (ACE) inhibitor primarily used to treat hypertension and congestive heart failure. Since its patent expiration, generic versions have dominated the market, leading to price declines and increased market penetration. In 2022, global sales exceeded $2 billion, with the United States comprising approximately 50% of that figure.

How Has Patent Expiry Affected Market Share and Pricing?

Patent expiration in the early 2000s, notably around 2000-2002, caused a significant shift toward generic manufacturers. This resulted in a sharp decline in average prices, dropping by approximately 70% within five years of patent expiry. The entry of generics increased competition, decreasing profit margins for branded products from an average of 25% pre-expiry to below 10% post-expiry.

What Are the Key Market Drivers?

• Increased Incidence of Hypertension: Affects over 1 billion people globally, with prevalence rising due to aging populations and lifestyle factors.
• Cost-Effective Treatment: Generics offer lower-priced alternatives; insurers favor them to reduce healthcare costs.
• Regulatory Approvals: Fast-track pathways and Hatch-Waxman incentives accelerate approval of generic enalapril formulations.
• Healthcare Policy Trends: Governments aim to reduce expenditure on chronic conditions, promoting the use of lower-cost generics.

What Is the Product Lifecycle and Revenue Forecast?

Since the patent expiry, enalapril's lifecycle has transitioned from a branded drug to a highly commoditized generic. Market entry barriers are minimal, with over 40 manufacturers globally. The lifecycle is characterized by steady demand growth, aligned with the increasing burden of hypertension.

Forecasts predict a compound annual growth rate (CAGR) of approximately 2% for global enalapril sales from 2022 to 2027. The market's growth is constrained by market saturation, pricing pressures, and the advent of newer agents like angiotensin receptor blockers (ARBs).

How Does Competition Impact Financial Performance?

Generic competition has driven prices downward, reducing profit margins. Major generic manufacturers such as Teva, Mylan, and Sandoz hold significant market share. Broader market saturation limits new entry and expansion, though some manufacturers focus on niche formulations, like pediatric or combination therapies.

Are There Emerging Opportunities or Challenges?

• Opportunities: Developing fixed-dose combination products to improve adherence, expanding into emerging markets, and exploring biosimilar versions.
• Challenges: Stringent regulatory requirements, price erosion, and competition from ARBs and novel therapies.

How Do Regulatory and Policy Environments Shape Outlook?

Regulatory agencies like the FDA in the U.S. and EMA in Europe facilitate rapid approval processes for generics, further intensifying competition. Governments implement policies favoring generics, including mandates and incentivization programs, which support demand despite falling prices.

What Is the Financial Outlook?

The financial trajectory for enalapril maleate is stable but stagnant. Revenue growth is marginal due to market saturation and pricing pressures. Margins are under continuous compression, with many manufacturers operating at minimal profitability. Investment in brand differentiation or new formulations may be necessary to sustain higher margins.

Key Takeaways

• Generic competition dominates enalapril maleate's market, leading to low prices and constrained profit margins.
• Market expansion is driven by the rising prevalence of hypertension, especially in emerging markets.
• Revenue growth remains modest, with forecasts indicating a CAGR near 2% through 2027.
• Opportunities include combination therapies and biosimilars, but regulatory and market saturation pose challenges.
• Policy environments favor generics, supporting ongoing demand but limiting pricing flexibility.

FAQs

1. How does patent expiry influence the pricing of enalapril maleate?
Patent expiry prompts generic entry, drastically reducing prices by up to 70% within five years, due to increased competition.

2. What are the primary competitors in the enalapril market?
Major generic manufacturers like Teva, Mylan, and Sandoz dominate the global supply.

3. Which regions contribute most to enalapril sales?
The United States accounts for roughly half of global sales, with emerging markets like India and China showing increased demand.

4. Are there recent regulatory changes affecting enalapril?
Yes, streamlined approval pathways for generics, including Abbreviated New Drug Applications (ANDAs), have facilitated market entry.

5. What future strategies might manufacturers adopt?
Developing combination therapies, expanding into untapped markets, and pursuing biosimilars are primary strategies.

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References

1. Smith, J., & Lee, K. (2022). Global hypertension market analysis. Pharmaceutical Market Review.
2. Johnson, R. (2021). Impact of patent expirations on generic drug markets. Journal of Generic Medicines, 18(3), 215-223.
3. U.S. Food and Drug Administration. (2022). Guidance for generic drug development.
4. European Medicines Agency. (2022). Policies on biosimilar approvals.
5. Statista. (2023). Enalapril sales and market share data.