LOTENSIN Drug Patent Profile

When do Lotensin patents expire, and what generic alternatives are available?

Lotensin is a drug marketed by Validus Pharms and is included in two NDAs.

The generic ingredient in LOTENSIN is benazepril hydrochloride; hydrochlorothiazide. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the benazepril hydrochloride; hydrochlorothiazide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lotensin

A generic version of LOTENSIN was approved as benazepril hydrochloride; hydrochlorothiazide by ANI PHARMS on February 11^th, 2004.

Summary for LOTENSIN

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	13
Patent Applications:	2,050
Drug Prices:	Drug price information for LOTENSIN
What excipients (inactive ingredients) are in LOTENSIN?	LOTENSIN excipients list
DailyMed Link:	LOTENSIN at DailyMed

See drug prices for LOTENSIN

See drug sales revenues for LOTENSIN

Recent Clinical Trials for LOTENSIN

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

Sponsor	Phase
Nanjing Children's Hospital	Phase 2
University of Nebraska	Phase 4
Peking University First Hospital	Phase 1/Phase 2

See all LOTENSIN clinical trials

Pharmacology for LOTENSIN

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

US Patents and Regulatory Information for LOTENSIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Validus Pharms	LOTENSIN	benazepril hydrochloride	TABLET;ORAL	019851-001	Jun 25, 1991		DISCN	Yes	No
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-004	May 19, 1992	AB	RX	Yes	No
Validus Pharms	LOTENSIN	benazepril hydrochloride	TABLET;ORAL	019851-004	Jun 25, 1991	AB	RX	Yes	No

Expired US Patents for LOTENSIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LOTENSIN	benazepril hydrochloride	TABLET;ORAL	019851-001	Jun 25, 1991
Validus Pharms	LOTENSIN	benazepril hydrochloride	TABLET;ORAL	019851-004	Jun 25, 1991
Validus Pharms	LOTENSIN	benazepril hydrochloride	TABLET;ORAL	019851-003	Jun 25, 1991

International Patents for LOTENSIN

See the table below for patents covering LOTENSIN around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	207091	SUBSTITUTED BENZAZEPINONES AND PHARMACEUTICAL COMPOSITIONS
Austria	18397
Japan	H0421665

LOTENSIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: LOTENSIN (Benazepril)

Introduction

LOTENSIN, known generically as benazepril, is an angiotensin-converting enzyme (ACE) inhibitor used primarily to treat hypertension and certain types of heart failure. The market dynamics and financial trajectory of benazepril are influenced by several key factors, including the global prevalence of hypertension, market competition, and economic trends.

Global Prevalence of Hypertension

The primary driver for the benazepril market is the increasing global prevalence of hypertension. According to the World Health Organization, hypertension affects over 1.28 billion people worldwide, making it a major risk factor for cardiovascular disorders such as heart attacks and strokes[1][4].

Market Size and Growth

The global benazepril market is substantial and growing. As of 2024, the global market size is estimated at USD 102,514.2 million, with a projected compound annual growth rate (CAGR) of 5.50% from 2024 to 2031[1].

Regional Market Breakdown

• North America: This region holds the largest market share, with a market size of USD 57,562.4 million in 2024 and a CAGR of 3.7% from 2024 to 2031. The United States is the dominant market within North America, with a market size of USD 32,353.5 million and a CAGR of 3.5%[1].
• Europe: Europe accounts for over 30% of the global revenue, with a market size of USD 30,754.3 million in 2024 and a CAGR of 4.0% from 2024 to 2031. Key markets include the United Kingdom, France, and Germany[1].
• Asia Pacific: This region holds around 23% of the global revenue, with a market size of USD 23,578.27 million in 2024 and a CAGR of 7.5% from 2024 to 2031, making it one of the fastest-growing regions[1].
• Latin America and Middle East & Africa: These regions contribute smaller but significant shares, with market sizes of USD 5,125.7 million and USD 2,050.28 million respectively in 2024, and CAGRs of 4.9% and 5.2% from 2024 to 2031[1].

Key Drivers

Growing Demand for Antihypertensive Medications

The increasing prevalence of hypertension, driven by lifestyle factors such as poor diet, lack of exercise, and stress, is a major driver for the benazepril market. Health care professionals are prescribing benazepril more frequently to manage blood pressure and prevent cardiovascular complications[1][4].

Generic Availability

The availability of generic versions of benazepril has made the medication more affordable for cost-conscious healthcare systems and patients. This has bolstered the market presence of benazepril, especially in regions where generic drugs are preferred[4].

Combination Therapies

Benazepril is often used in combination with other medications such as diuretics or calcium channel blockers. This trend towards combination therapies reflects the evolving treatment landscape for hypertension and related cardiovascular conditions[4].

Research and Innovation

Ongoing research into new formulations and dosage regimens of benazepril promises further innovation in the ACE inhibitor market. This continuous improvement helps maintain the drug's relevance and effectiveness in treating hypertension[4].

Financial Performance of Key Players

Companies involved in the production and distribution of benazepril, such as Viatris, report strong financial and operational results. For example, Viatris reported total net sales of $3.93 billion in the third quarter of 2023, with a year-over-year operational revenue growth on a divestiture-adjusted basis[2].

Revenue and Profit Margins

The financial performance of these companies is influenced by the sales of benazepril and other pharmaceutical products. Adjusted gross margins and adjusted EBITDA are key indicators of financial health, with Viatris reporting an adjusted gross margin of 59.2% and adjusted EBITDA of $1.36 billion in the third quarter of 2023[2].

Impact of Drug Price Dynamics

Drug price dynamics play a significant role in the cost-effectiveness and financial trajectory of benazepril. Studies have shown that price increases during the exclusivity period and price decreases after the loss of exclusivity can significantly impact the cost per quality-adjusted life-year (QALY) gained. For instance, a 2% yearly price increase followed by a 25% post-exclusivity price decrease can result in varying cost-effectiveness ratios[3].

Manufacturing and Cost Analysis

The setup and cost analysis of benazepril manufacturing plants are crucial for understanding the financial viability of producing this drug. The report on benazepril manufacturing plants provides insights into the industry landscape, segment-wise and region-wise breakups, and price analysis of feedstocks used in manufacturing. It also details industry profit margins, which are essential for pharmaceutical companies to maintain profitability[4].

Key Takeaways

• The global benazepril market is driven by the increasing prevalence of hypertension and the need for effective antihypertensive medications.
• North America, particularly the United States, holds the largest market share, followed by Europe and the Asia Pacific.
• Generic availability and combination therapies are significant factors influencing market dynamics.
• Ongoing research and innovation in benazepril formulations are crucial for maintaining market relevance.
• Financial performance of key players is strong, with adjusted gross margins and EBITDA being key indicators.
• Drug price dynamics significantly impact the cost-effectiveness and financial trajectory of benazepril.

FAQs

What is the current global market size for benazepril?

The global benazepril market size is estimated at USD 102,514.2 million as of 2024[1].

What is the projected CAGR for the global benazepril market from 2024 to 2031?

The global benazepril market is projected to grow at a CAGR of 5.50% from 2024 to 2031[1].

Which region holds the largest market share for benazepril?

North America holds the largest market share, with over 40% of the global revenue, primarily driven by the United States market[1].

How does the generic availability of benazepril impact the market?

The generic availability of benazepril makes it more affordable, bolstering its market presence, especially in cost-conscious healthcare systems and among patients[4].

What are the key drivers for the benazepril market?

Key drivers include the growing global prevalence of hypertension, lifestyle factors, generic availability, combination therapies, and ongoing research into new formulations[1][4].

How do drug price dynamics affect the cost-effectiveness of benazepril?

Drug price dynamics, including price increases during exclusivity and decreases post-exclusivity, can significantly impact the cost per QALY gained, affecting the cost-effectiveness of benazepril[3].

Sources

1. Cognitive Market Research: Benazepril Market Report 2024 (Global Edition)
2. Viatris Newsroom: Viatris Reports Strong Financial and Operational Results for the Third Quarter 2023
3. PubMed: The Influence of US Drug Price Dynamics on Cost-Effectiveness Analyses
4. IMARC Group: Benazepril (Lotensin) Manufacturing Plant Report: Setup & Cost