ACEBUTOLOL HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for acebutolol hydrochloride and what is the scope of patent protection?

Acebutolol hydrochloride is the generic ingredient in two branded drugs marketed by Amneal Pharm, Ani Pharms, Norvium Bioscience, and Promius Pharma, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for acebutolol hydrochloride. Six suppliers are listed for this compound.

Summary for ACEBUTOLOL HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	7
Patent Applications:	2,933
What excipients (inactive ingredients) are in ACEBUTOLOL HYDROCHLORIDE?	ACEBUTOLOL HYDROCHLORIDE excipients list
DailyMed Link:	ACEBUTOLOL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ACEBUTOLOL HYDROCHLORIDE

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

Sponsor	Phase
Weill Medical College of Cornell University	Phase 4
National Institute on Aging (NIA)	Phase 4
The New York Community Trust	Phase 4

See all ACEBUTOLOL HYDROCHLORIDE clinical trials

Pharmacology for ACEBUTOLOL HYDROCHLORIDE

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for ACEBUTOLOL HYDROCHLORIDE

Adrenergic beta-1 Receptor Antagonists

Anti-Arrhythmia Agents

Antihypertensive Agents

Sympathomimetics

Anatomical Therapeutic Chemical (ATC) Classes for ACEBUTOLOL HYDROCHLORIDE

C07AB	Beta blocking agents, selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for ACEBUTOLOL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	ACEBUTOLOL HYDROCHLORIDE	acebutolol hydrochloride	CAPSULE;ORAL	074288-002	Apr 24, 1995		DISCN	No	No
Amneal Pharm	ACEBUTOLOL HYDROCHLORIDE	acebutolol hydrochloride	CAPSULE;ORAL	075047-002	Dec 30, 1999	AB	RX	No	Yes
Ani Pharms	ACEBUTOLOL HYDROCHLORIDE	acebutolol hydrochloride	CAPSULE;ORAL	074007-001	Oct 18, 1995	AB	RX	No	No
Amneal Pharm	ACEBUTOLOL HYDROCHLORIDE	acebutolol hydrochloride	CAPSULE;ORAL	075047-001	Dec 30, 1999	AB	RX	No	Yes

Expired US Patents for ACEBUTOLOL HYDROCHLORIDE

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

ACEBUTOLOL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acebutolol Hydrochloride

Introduction to Acebutolol Hydrochloride

Acebutolol hydrochloride is a selective β1-receptor antagonist used primarily for the management of hypertension and ventricular premature beats in adults. It is known for its cardioselective properties and mild intrinsic sympathomimetic activity (ISA)[2][5].

Market Size and Growth

The global market for acebutolol hydrochloride has been valued at approximately USD 400 million in 2023. Projections indicate that this market is expected to grow significantly, reaching USD 680 million by 2032. This growth is driven by increasing demand for effective hypertension management and the expanding geriatric population, which is more prone to cardiovascular diseases[4].

Competitive Landscape

Acebutolol hydrochloride operates in a competitive market dominated by various beta-blockers. However, its unique profile, which includes less antagonistic effects on peripheral vascular β2-receptors and minimal bronchoconstriction, positions it favorably against nonselective beta-blockers like propranolol[2][5].

Recent Market Developments

In 2022, ANI Pharmaceuticals announced the launch of acebutolol hydrochloride capsules, marking another entry into a limited-competition market. This launch is part of ANI’s strategy to leverage its library of approved ANDAs (Abbreviated New Drug Applications) to bring back older generic drugs to the market. The current annual U.S. market for acebutolol hydrochloride capsules is approximately $10 million, according to IQVIA/IMS Health[1].

Financial Performance

The financial performance of acebutolol hydrochloride is influenced by several factors, including market demand, competition, and regulatory approvals. The launch by ANI Pharmaceuticals is expected to enhance the drug's market presence and contribute to its financial growth. Here are some key financial indicators:

• Market Value: The global market value is projected to increase from USD 400 million in 2023 to USD 680 million by 2032, indicating a significant growth trajectory[4].
• Revenue Streams: The revenue from acebutolol hydrochloride is generated through prescription sales, with the drug available in various formulations such as capsules and tablets. The pricing varies by region and formulation, but it generally remains competitive within the beta-blocker market[2][5].

Pricing and Cost Analysis

The pricing of acebutolol hydrochloride varies based on the formulation and dosage. Here are some examples of pricing:

• Capsules: The cost of acebutolol hydrochloride capsules can range from approximately $1.39 per 400 mg capsule to $1.01 per 200 mg capsule[2].
• Tablets: The cost of tablets is similarly competitive, with prices ranging from $0.51 per 400 mg tablet to $0.17 per 100 mg tablet[2].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of acebutolol hydrochloride. Approvals and compliance with regulatory standards are essential for maintaining market presence. For instance, ANI Pharmaceuticals' launch of acebutolol hydrochloride capsules was facilitated by the drug's approval as a generic version of the Reference Listed Drug (RLD) Sectral[1].

Market Drivers

Several factors drive the market for acebutolol hydrochloride:

• Increasing Prevalence of Hypertension: The growing prevalence of hypertension globally drives the demand for effective antihypertensive medications like acebutolol hydrochloride.
• Aging Population: The increasing geriatric population, which is more susceptible to cardiovascular diseases, contributes to the growing demand for beta-blockers.
• Generic Competition: The entry of generic versions, such as ANI Pharmaceuticals' launch, increases market competition and can drive down prices, making the drug more accessible to a wider population[1][4].

Market Challenges

Despite the growth potential, the market for acebutolol hydrochloride faces several challenges:

• Competition from Other Beta-Blockers: The market is highly competitive with other beta-blockers, some of which may have broader indications or stronger brand recognition.
• Regulatory Risks: Changes in regulatory policies or delays in approvals can impact the commercialization and sales of the drug.
• Adverse Effects and Safety Concerns: Beta-blockers, including acebutolol, can have significant adverse effects such as bradycardia, heart failure, and hypotension, which can affect patient compliance and market growth[2][3][5].

Future Outlook

The future outlook for acebutolol hydrochloride is positive, driven by the growing demand for antihypertensive medications and the expanding generic market. Here are some key points:

• Growth Projections: The market is expected to grow to USD 680 million by 2032, indicating a robust financial trajectory[4].
• Market Expansion: The launch of generic versions and the increasing acceptance of beta-blockers in various therapeutic indications are expected to expand the market.
• Innovation and Development: Continuous innovation in drug formulations and delivery systems could further enhance the market position of acebutolol hydrochloride[1][4].

Key Takeaways

• Market Growth: The global market for acebutolol hydrochloride is projected to grow significantly, reaching USD 680 million by 2032.
• Competitive Landscape: The drug operates in a competitive beta-blocker market but has unique properties that position it favorably.
• Financial Performance: The financial performance is influenced by market demand, competition, and regulatory approvals.
• Regulatory Environment: Compliance with regulatory standards is crucial for maintaining market presence.
• Market Drivers and Challenges: Increasing prevalence of hypertension, aging population, and generic competition drive the market, while competition from other beta-blockers and regulatory risks pose challenges.

FAQs

Q: What is the primary use of acebutolol hydrochloride? A: Acebutolol hydrochloride is primarily used for the management of hypertension and ventricular premature beats in adults.

Q: Who recently launched a generic version of acebutolol hydrochloride? A: ANI Pharmaceuticals announced the launch of acebutolol hydrochloride capsules in 2022.

Q: What is the projected global market size for acebutolol hydrochloride by 2032? A: The global market for acebutolol hydrochloride is expected to reach USD 680 million by 2032.

Q: What are the unique properties of acebutolol hydrochloride compared to other beta-blockers? A: Acebutolol hydrochloride has less antagonistic effects on peripheral vascular β2-receptors and minimal bronchoconstriction, and it possesses mild intrinsic sympathomimetic activity (ISA).

Q: What are the potential adverse effects of acebutolol hydrochloride? A: Potential adverse effects include bradycardia, heart failure, hypotension, and in susceptible patients, bronchospasm and hypoglycemia.

Sources

1. ANI Pharmaceuticals Announces the Launch of Acebutolol Hydrochloride Capsules USP - Business Wire
2. Acebutolol: Uses, Interactions, Mechanism of Action | DrugBank Online - DrugBank
3. Drug Class Review Beta Adrenergic Blockers - OHSU
4. Acebutolol Hydrochloride Market Research Report 2032 - Dataintelo
5. ACEBUTOLOL HYDROCHLORIDE CAPSULES, USP - DailyMed