SECTRAL Drug Patent Profile

Which patents cover Sectral, and what generic alternatives are available?

Sectral is a drug marketed by Promius Pharma and is included in one NDA.

The generic ingredient in SECTRAL is acebutolol hydrochloride. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acebutolol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sectral

A generic version of SECTRAL was approved as acebutolol hydrochloride by ANI PHARMS on October 18^th, 1995.

Summary for SECTRAL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	3
Patent Applications:	5,361
What excipients (inactive ingredients) are in SECTRAL?	SECTRAL excipients list
DailyMed Link:	SECTRAL at DailyMed

Recent Clinical Trials for SECTRAL

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

Sponsor	Phase
Centre Hospitalier Universitaire de Saint Etienne	Phase 4
University Hospital, Montpellier	Phase 3
Duke Clinical Research Institute	N/A

See all SECTRAL clinical trials

US Patents and Regulatory Information for SECTRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Promius Pharma	SECTRAL	acebutolol hydrochloride	CAPSULE;ORAL	018917-001	Dec 28, 1984		DISCN	Yes	No
Promius Pharma	SECTRAL	acebutolol hydrochloride	CAPSULE;ORAL	018917-003	Dec 28, 1984		DISCN	Yes	No

Expired US Patents for SECTRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Promius Pharma	SECTRAL	acebutolol hydrochloride	CAPSULE;ORAL	018917-001	Dec 28, 1984	3,726,919
Promius Pharma	SECTRAL	acebutolol hydrochloride	CAPSULE;ORAL	018917-003	Dec 28, 1984	3,857,952
Promius Pharma	SECTRAL	acebutolol hydrochloride	CAPSULE;ORAL	018917-003	Dec 28, 1984	3,726,919

International Patents for SECTRAL

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

Country	Patent Number	Title	Estimated Expiration
Austria	292671
Germany	1815808
Malaysia	7400060	BENZENE DERIVATIVES

SECTRAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SECTRAL

Introduction

SECTRAL, also known as acebutolol hydrochloride, is a selective, hydrophilic beta-adrenoreceptor blocking agent used primarily to treat hypertension and ventricular arrhythmias. Understanding the market dynamics and financial trajectory of SECTRAL involves analyzing various factors, including market trends, competition, regulatory environment, and financial performance.

Market Trends in Cardiovascular Disease Drugs

The global cardiovascular disease drugs market has experienced significant growth, particularly during the COVID-19 pandemic. This growth is driven by several factors, including an increase in the prevalence of cardiovascular diseases, favorable regulatory environments, and government investments in healthcare infrastructure[1].

Competitive Landscape

The cardiovascular disease drugs market is highly competitive, with several key players dominating the market. SECTRAL, as a beta-blocker, competes with other hypertension drugs such as Tracleer and Letairis, as well as traditional calcium channel blockers and beta-blockers like propranolol and hydrochlorothiazide[1][4].

Regional Market Performance

North America is expected to capture a major share of the global cardiovascular disease drugs market due to a favorable regulatory environment and significant government funding for life sciences research. The Asia Pacific region is also projected to grow rapidly, driven by increased research and development activities and government initiatives to improve healthcare[1].

Demand and Usage

SECTRAL has demonstrated effectiveness in treating hypertension and ventricular arrhythmias, with its antihypertensive effect shown to be superior to placebo and similar to other established treatments like propranolol and hydrochlorothiazide. The drug's efficacy and safety profile contribute to its demand, especially in elderly patients where it has been used successfully without significant dosage adjustments[4].

Pricing and Affordability

The cost of SECTRAL can be a significant factor in its market dynamics. For instance, a supply of 100 capsules of SECTRAL 200 mg can cost around $391, depending on the pharmacy. This pricing makes it a relatively expensive option, which could impact its adoption rate, especially in regions with limited healthcare budgets[5].

Financial Performance of Similar Drugs

To gauge the financial trajectory of SECTRAL, it is helpful to look at the performance of similar cardiovascular drugs. For example, AstraZeneca's cardiovascular drugs like Brilinta and Farxiga have shown strong revenue growth. Farxiga, in particular, saw a 43% increase in sales, driven by continued demand and the launch of an authorized generic in the US[2].

Research and Development Costs

The development of cardiovascular drugs, including beta-blockers like SECTRAL, involves significant research and development (R&D) costs. Studies have shown that for every dollar invested in R&D, the median return in sales income can be substantial. For example, a study on FDA-approved cancer drugs found that $1 invested in R&D generated a median return of $14.50 in sales income, although this figure can vary widely depending on the drug and its market performance[3].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pharmaceuticals. Favorable regulatory conditions can expedite the approval process and reduce barriers to market entry. In regions like North America, the regulatory environment is particularly supportive, which can enhance the financial trajectory of drugs like SECTRAL[1].

Government Initiatives and Healthcare Infrastructure

Government investments in healthcare infrastructure and initiatives to improve healthcare access are key drivers for the demand of cardiovascular disease drugs. In developing countries, these investments are expected to increase access to healthcare, thereby driving the demand for drugs like SECTRAL[1].

Patient Demographics and Needs

The geriatric population is a significant demographic for SECTRAL, given its efficacy in elderly patients. The bioavailability of SECTRAL and its metabolite is approximately doubled in elderly patients, which may require lower maintenance doses but does not necessitate specific dosage adjustments[4].

Market Projections and Growth Potential

The global cardiovascular disease drugs market is projected to continue growing, driven by the increasing prevalence of cardiovascular diseases and advancements in healthcare infrastructure. While SECTRAL faces competition, its established safety and efficacy profile position it for continued market presence and potential growth, especially in regions with aging populations and rising healthcare needs[1].

Key Takeaways

• Market Growth: The cardiovascular disease drugs market is expected to grow, driven by increasing prevalence and government investments.
• Competitive Landscape: SECTRAL competes with other hypertension drugs, but its efficacy and safety profile maintain its market presence.
• Regional Performance: North America and Asia Pacific are key regions for growth.
• Pricing and Affordability: SECTRAL's cost can impact its adoption, especially in budget-constrained regions.
• Financial Performance: Similar drugs have shown strong revenue growth, indicating potential for SECTRAL.
• Regulatory Environment: Favorable regulations can enhance market entry and growth.

FAQs

1. What is SECTRAL used for? SECTRAL (acebutolol hydrochloride) is used to treat hypertension and ventricular arrhythmias.

2. How does SECTRAL compare to other hypertension drugs? SECTRAL has an antihypertensive effect similar to propranolol and hydrochlorothiazide, but it competes with newer drugs like Tracleer and Letairis.

3. What is the cost of SECTRAL? A supply of 100 capsules of SECTRAL 200 mg can cost around $391, depending on the pharmacy.

4. How does the regulatory environment impact SECTRAL? A favorable regulatory environment, especially in regions like North America, can facilitate market entry and growth for SECTRAL.

5. What are the key regions for the growth of SECTRAL? North America and the Asia Pacific region are expected to be significant markets for SECTRAL due to favorable regulatory environments and growing healthcare needs.

Cited Sources

1. Biospace: Cardiovascular Disease Drugs Market Outlook, Competitive Landscape and Forecasts to 2031.
2. AstraZeneca: Q1 2024 results announcement.
3. JAMA Network: Sales Income and R&D Costs for FDA-Approved Cancer Drugs Sold in the United States.
4. DailyMed: Label: SECTRAL - acebutolol hydrochloride capsule.
5. Drugs.com: Sectral Prices, Coupons, Copay Cards & Patient Assistance.