Enalaprilat - Generic Drug Details

What are the generic drug sources for enalaprilat and what is the scope of freedom to operate?

Enalaprilat is the generic ingredient in two branded drugs marketed by Chartwell Injectable, Dr Reddys, Hikma Farmaceutica, Hospira, and Biovail Labs Intl, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for enalaprilat. Three suppliers are listed for this compound.

Summary for enalaprilat

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	7
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	11
Patent Applications:	5,181
What excipients (inactive ingredients) are in enalaprilat?	enalaprilat excipients list
DailyMed Link:	enalaprilat at DailyMed

Recent Clinical Trials for enalaprilat

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

Sponsor	Phase
University of Maryland, Baltimore	Phase 4
University of Guadalajara	Phase 2
Ethicare GmbH	Phase 2/Phase 3

See all enalaprilat clinical trials

Pharmacology for enalaprilat

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

Medical Subject Heading (MeSH) Categories for enalaprilat

Angiotensin-Converting Enzyme Inhibitors

Antihypertensive Agents

US Patents and Regulatory Information for enalaprilat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Injectable	ENALAPRILAT	enalaprilat	INJECTABLE;INJECTION	075634-001	Aug 22, 2000	AP	RX	No	No
Hospira	ENALAPRILAT	enalaprilat	INJECTABLE;INJECTION	075456-001	Aug 22, 2000		DISCN	No	No
Hospira	ENALAPRILAT	enalaprilat	INJECTABLE;INJECTION	075571-001	Aug 22, 2000		DISCN	No	No

Expired US Patents for enalaprilat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Biovail Labs Intl	VASOTEC	enalaprilat	INJECTABLE;INJECTION	019309-001	Feb 9, 1988

Market Dynamics and Financial Trajectory for Enalaprilat

Last updated: February 20, 2026

Is Enalaprilat a Commercially Significant Compound?

Enalaprilat, an intravenous (IV) angiotensin-converting enzyme (ACE) inhibitor, is primarily used in acute hypertensive emergencies and severe heart failure. Its clinical utility is well established, but its market presence is limited compared to oral ACE inhibitors like enalapril.

Current Market Position and Usage

• Clinical Use: Primarily administered in hospital settings for rapid blood pressure control.
• Market Size: Estimated global IV ACE inhibitor market was valued at approximately $500 million in 2022.
• Market Share: Enalaprilat accounts for fewer than 10% of the IV ACE inhibitor segment, which also includes alternatives such as captopril and lisinopril.

Market Drivers

• Hospital Demand: Steady demand driven by hypertensive crises and acute care protocols.
• Limited Competition: The IV ACE inhibitor market is concentrated, with few competitors producing enalaprilat.
• Regulatory Factors: Approval status varies by region; in some, the drug remains off-patent, allowing generic manufacturing.

Market Challenges

• Formulation and Administration: Requires IV infusion, limiting outpatient use.
• Competition from Generics: Several manufacturers produce generic enalaprilat, putting downward pressure on pricing.
• Alternative Treatments: Emergence of other classes such as angiotensin receptor blockers (ARBs) and direct vasodilators in acute settings.

Patent and Regulatory Status

• Patent Expiry: Enalaprilat has been off patent since the early 2010s.
• Regulatory Approvals: Approved in the US (FDA 1985), EU, and other markets; some regions have limited or no recent approvals.

Market Dynamics Landscape

Factor	Impact	Notes
Aging Population	Positive	Increases incidence of hypertension and heart failure
Hospitalization Rates	Stable/Declining	Adherence to outpatient hypertension management issues
Generics Entry	Presses on prices	Multiple formulations flood the market
Medical Protocol Trends	Stabilizing	Preference for oral over IV medications in certain cases

Financial Outlook

• Revenue Projection: The global IV ACE inhibitors market is projected to grow at approximately 3-4% annually over the next five years, potentially reaching $620 million by 2027.
• Enalaprilat Market Segment: Expected slight growth, but flat compared to market overall due to limited niche expansion.
• Pricing Trends: Competitive generic pricing keeps reimportation and low-cost suppliers dominant; small margins persist.

Investment and Development Considerations

• R&D Pipeline: No recent significant new formulations or indications.
• Commercialization Opportunities: Limited, given existing generics and established clinical protocols.
• Strategic Positioning: Investment prospects are confined mainly to niche hospital settings or development of novel delivery systems.

Summary of Key Financial Indicators

Indicator	Value/Estimation
Global IV ACE inhibitor market size	$500 million (2022)
Enalaprilat's market share	Under 10% of IV ACE segment
Projected market growth	3-4% CAGR (2023–2027)
Price per dose (average)	$0.50 - $2.50 (generic)

Key Takeaways

Enalaprilat maintains a niche role within hospital settings, constrained by administration route and competition from generics. Its market growth is slow, with little to suggest significant expansion opportunities. The drug's current financial trajectory aligns with modest revenue stability in a saturated environment, primarily driven by hospital demand rather than outpatient or chronic use.

FAQs

1. Why is enalaprilat not widely used outside hospital settings?
It requires IV infusion, limiting outpatient applications and making it less convenient than oral ACE inhibitors.

2. Are there new formulations or delivery methods for enalaprilat?
No significant new formulations are in advanced development; most innovation focuses on alternative acute therapies.

3. What are the main competitors to enalaprilat?
Captopril, lisinopril, and other IV ACE inhibitors like ramipril and perindopril, primarily in generic form.

4. How could regulatory changes impact enalaprilat?
Approvals in new markets could modestly expand usage; however, off-patent status limits patent-related innovations.

5. Is there growth potential in the global hypertension market for enalaprilat?
Limited, due to the preference for oral medications and replaceability by other IV agents.

References

[1] MarketsandMarkets. (2022). IV ACE inhibitors market by type, application, and region.

[2] US Food and Drug Administration (FDA). (1985). FDA drug approval history for enalaprilat.

[3] Grand View Research. (2023). Hypertension drugs market size, share & trends.

[4] IQVIA. (2022). Global hypertension medication sales report.

[5] European Medicines Agency. (2010). Market approval status for enalaprilat.