ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE - Generic Drug Details

What are the generic sources for enalapril maleate; hydrochlorothiazide and what is the scope of patent protection?

Enalapril maleate; hydrochlorothiazide is the generic ingredient in two branded drugs marketed by Chartwell Rx, Cosette, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Nostrum Labs Inc, Rising, Taro Pharm Inds, and Bausch, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	1
DailyMed Link:	ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE at DailyMed

Pharmacology for ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

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

US Patents and Regulatory Information for ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	VASERETIC	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	019221-003	Jul 12, 1995	AB	RX	Yes	No
Taro Pharm Inds	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	075788-002	Sep 18, 2001	AB	RX	No	No
Cosette	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	075727-002	Sep 18, 2001		DISCN	No	No
Taro Pharm Inds	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	075788-001	Sep 18, 2001	AB	RX	No	No

Expired US Patents for ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	VASERETIC	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	019221-003	Jul 12, 1995	4,374,829*PED
Bausch	VASERETIC	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	019221-001	Oct 31, 1986	4,472,380*PED
Bausch	VASERETIC	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	019221-001	Oct 31, 1986	4,374,829*PED
Bausch	VASERETIC	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	019221-003	Jul 12, 1995	4,472,380*PED

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Enalapril Maleate and Hydrochlorothiazide

Introduction

Enalapril maleate, an angiotensin-converting enzyme (ACE) inhibitor, and hydrochlorothiazide, a thiazide diuretic, are commonly used in combination to treat hypertension, heart failure, and asymptomatic left ventricular dysfunction. Understanding the market dynamics and financial trajectory of this drug combination is crucial for pharmaceutical companies, investors, and healthcare providers.

FDA Approval and Indications

Enalapril maleate was approved by the US Food and Drug Administration (FDA) for the treatment of heart failure, chronic hypertension, and asymptomatic left ventricular dysfunction. The FDA also approved a fixed-dose combination of enalapril with hydrochlorothiazide, which has become a standard treatment regimen for these conditions[4].

Market Competition

The market for antihypertensive drugs, including ACE inhibitors and diuretics, is highly competitive. The presence of a few dominant players and the availability of generic versions of these drugs influence market dynamics. Companies invest heavily in promotional activities to differentiate their products and maintain market share. For instance, in the market for oral diuretics, promotional expenditures account for a higher percentage of total sales compared to other pharmaceutical markets[3].

Pricing and Revenue

The pricing of enalapril maleate and hydrochlorothiazide combination tablets is influenced by several factors, including production costs, regulatory approvals, and market competition. Generic versions of these drugs are often priced lower than their brand-name counterparts, which can impact revenue for pharmaceutical companies. However, the combination of enalapril and hydrochlorothiazide remains a lucrative market segment due to its efficacy and widespread use.

Sales and Market Share

The combination of enalapril maleate and hydrochlorothiazide has maintained a significant market share in the antihypertensive drug market. This is attributed to its proven efficacy, as demonstrated by clinical trials showing a marked reduction in blood pressure when these drugs are used together compared to when used individually[1][2].

Promotional Expenditures

Pharmaceutical companies spend substantial amounts on promotional activities to promote their products. In the case of oral diuretics and ACE inhibitors, these expenditures are particularly high due to the competitive nature of the market. Companies use various strategies, including direct-to-consumer advertising, physician detailing, and sponsorship of clinical trials, to differentiate their products and increase market share[3].

Patient Compliance and Adherence

Patient compliance and adherence to treatment regimens are critical factors influencing the financial trajectory of enalapril maleate and hydrochlorothiazide. The combination's well-tolerated profile and the convenience of a fixed-dose formulation contribute to higher adherence rates. Studies have shown that the antihypertensive effects of enalapril maleate are maintained for at least 24 hours, which helps in ensuring patient compliance[2].

Regulatory Considerations

Regulatory approvals and guidelines play a significant role in shaping the market dynamics of enalapril maleate and hydrochlorothiazide. The FDA's approval and the inclusion of these drugs in guideline-directed medical therapy by organizations such as the American Heart Association (AHA) and the American College of Cardiology (ACC) enhance their market position[4].

Pharmacoeconomics

The pharmacoeconomic profile of enalapril maleate and hydrochlorothiazide is favorable due to their cost-effectiveness in managing hypertension and related conditions. The long-term use of these drugs can reduce the incidence of cardiovascular events, thereby lowering overall healthcare costs. This makes them an attractive option for both patients and healthcare systems.

Adverse Effects and Safety Profile

While enalapril maleate and hydrochlorothiazide are generally well-tolerated, their safety profile can impact market dynamics. Adverse effects such as symptomatic hypotension, hyperesthesia of the oral mucosa, and rare but serious conditions like agranulocytosis or hepatic failure need to be monitored. These factors can influence prescribing decisions and patient adherence[1][2][4].

Generic Competition

The availability of generic versions of enalapril maleate and hydrochlorothiazide has significantly impacted the market. Generic drugs offer a cost-effective alternative, which can erode the market share of brand-name products. However, the combination of these drugs remains a staple in antihypertensive therapy, ensuring a stable demand even in the presence of generic competition.

International Market

The global market for antihypertensive drugs, including enalapril maleate and hydrochlorothiazide, is vast and growing. Emerging markets, particularly in regions with increasing prevalence of hypertension, present opportunities for expansion. However, regulatory hurdles, pricing pressures, and local competition can affect the financial trajectory in these markets.

Future Outlook

The future outlook for enalapril maleate and hydrochlorothiazide remains positive due to their established efficacy and safety profile. Continued research and development in the field of cardiovascular diseases may lead to new indications or formulations, further solidifying their market position. Additionally, the increasing global burden of hypertension ensures a sustained demand for these drugs.

Key Takeaways

• FDA Approval: Enalapril maleate and hydrochlorothiazide are FDA-approved for treating hypertension, heart failure, and asymptomatic left ventricular dysfunction.
• Market Competition: The market is highly competitive, with significant promotional expenditures.
• Pricing and Revenue: Pricing is influenced by production costs, regulatory approvals, and market competition.
• Patient Compliance: The combination's well-tolerated profile and fixed-dose formulation enhance patient adherence.
• Regulatory Considerations: FDA approvals and guideline-directed medical therapy support their market position.
• Pharmacoeconomics: The drugs are cost-effective in managing hypertension and related conditions.
• Adverse Effects: Monitoring of adverse effects is crucial but does not significantly impact market dynamics.
• Generic Competition: Generic versions affect market share but do not eliminate demand for the combination.
• International Market: Emerging markets offer growth opportunities despite regulatory and pricing challenges.

FAQs

What are the FDA-approved indications for enalapril maleate and hydrochlorothiazide?

Enalapril maleate and hydrochlorothiazide are FDA-approved for the treatment of heart failure, chronic hypertension, and asymptomatic left ventricular dysfunction[4].

How does the combination of enalapril maleate and hydrochlorothiazide affect blood pressure?

The combination results in a marked further reduction in blood pressure that is greater than the sum of the reductions achieved by each drug individually[1][2].

What are the common adverse effects of enalapril maleate and hydrochlorothiazide?

Common adverse effects include symptomatic hypotension, hyperesthesia of the oral mucosa, and rare but serious conditions like agranulocytosis or hepatic failure[1][2][4].

How does generic competition impact the market for enalapril maleate and hydrochlorothiazide?

Generic versions offer a cost-effective alternative, eroding the market share of brand-name products but not eliminating demand for the combination due to its established efficacy and safety profile.

What is the future outlook for enalapril maleate and hydrochlorothiazide in the global market?

The future outlook remains positive due to their established efficacy, safety profile, and the increasing global burden of hypertension, ensuring sustained demand for these drugs.

Sources

1. Comparative antihypertensive effects of enalapril maleate... - PubMed
2. TABLETS VASERETIC (ENALAPRIL MALEATE-HYDROCHLOROTHIAZIDE) - FDA
3. Sales, Promotion, and Product Differentiation in Two Prescription Drug Markets - FTC
4. Enalapril - StatPearls - NCBI Bookshelf - NCBI Bookshelf