HYTRIN Drug Patent Profile

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

Hytrin is a drug marketed by Abbott and is included in two NDAs.

The generic ingredient in HYTRIN is terazosin hydrochloride. There are twenty-four drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the terazosin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hytrin

A generic version of HYTRIN was approved as terazosin hydrochloride by APNAR PHARMA LP on March 30^th, 1998.

Summary for HYTRIN

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	260
Clinical Trials:	4
Patent Applications:	3,972
DailyMed Link:	HYTRIN at DailyMed

Recent Clinical Trials for HYTRIN

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

Sponsor	Phase
Michael J. Fox Foundation for Parkinson's Research	Phase 1
University of Iowa	Phase 1
University of Iowa	Phase 1/Phase 2

See all HYTRIN clinical trials

US Patents and Regulatory Information for HYTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbott	HYTRIN	terazosin hydrochloride	CAPSULE;ORAL	020347-001	Dec 14, 1994		DISCN	Yes	No
Abbott	HYTRIN	terazosin hydrochloride	TABLET;ORAL	019057-003	Aug 7, 1987		DISCN	No	No
Abbott	HYTRIN	terazosin hydrochloride	CAPSULE;ORAL	020347-004	Dec 14, 1994		DISCN	Yes	No
Abbott	HYTRIN	terazosin hydrochloride	TABLET;ORAL	019057-004	Aug 7, 1987		DISCN	No	No
Abbott	HYTRIN	terazosin hydrochloride	CAPSULE;ORAL	020347-002	Dec 14, 1994		DISCN	Yes	No
Abbott	HYTRIN	terazosin hydrochloride	CAPSULE;ORAL	020347-003	Dec 14, 1994		DISCN	Yes	No
Abbott	HYTRIN	terazosin hydrochloride	TABLET;ORAL	019057-002	Aug 7, 1987		DISCN	No	No

Expired US Patents for HYTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbott	HYTRIN	terazosin hydrochloride	TABLET;ORAL	019057-001	Aug 7, 1987	5,212,176
Abbott	HYTRIN	terazosin hydrochloride	TABLET;ORAL	019057-004	Aug 7, 1987	5,412,095
Abbott	HYTRIN	terazosin hydrochloride	CAPSULE;ORAL	020347-002	Dec 14, 1994	5,504,207
Abbott	HYTRIN	terazosin hydrochloride	CAPSULE;ORAL	020347-004	Dec 14, 1994	5,212,176
Abbott	HYTRIN	terazosin hydrochloride	TABLET;ORAL	019057-003	Aug 7, 1987	4,026,894
Abbott	HYTRIN	terazosin hydrochloride	TABLET;ORAL	019057-003	Aug 7, 1987	5,294,615
Abbott	HYTRIN	terazosin hydrochloride	TABLET;ORAL	019057-001	Aug 7, 1987	4,112,097

International Patents for HYTRIN

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

Country	Patent Number	Title	Estimated Expiration
Greece	960300047
Sweden	437157	1-(4-AMINO-6,7-DIMETOXI-2-KINAZOLINYL)-4-(2-TETRAHYDROFUROYL)PIPERAZINHYDROKLORID-DIHYDRAT OCH FARMACEUTISK KOMPOSITION (1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-tetrahydrofuryl)piperazine hydrochloride dihydrate and pharmaceutical composition)
Japan	S5543474
Hong Kong	124397	Terazosin polymorph and pharmaceutical composition
Spain	2093579
Sweden	8008533
Greece	960300046

HYTRIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for HYTRIN (Terazosin)

Market Overview

HYTRIN, also known as terazosin, is a medication primarily used to treat benign prostatic hyperplasia (BPH) and hypertension. The market for terazosin is influenced by several key factors.

Increasing Prevalence of BPH and Hypertension

The rising prevalence of BPH and hypertension, particularly among the aging population, is a significant market driver. As people age, the likelihood of developing these conditions increases, creating a sustained demand for medications like terazosin[1][4].

Growing Awareness and Medical Treatment

Growing patient awareness of the importance of managing BPH and hypertension has led to more individuals seeking medical treatment. This increased awareness contributes to the steady demand for terazosin and similar drugs[1][4].

Developments in Healthcare

Advancements in personalized medicine and changes in healthcare delivery methods also shape the market for terazosin. These developments often lead to better treatment options and increased accessibility, further driving the demand for this medication[1].

Global Market Trends

Historical Market Performance

The global terazosin market has shown stable growth over the past few years. From 2018 to 2023, the market experienced steady expansion driven by the increasing prevalence of BPH and hypertension[4].

Market Forecast

The market is expected to continue growing from 2024 to 2032, driven by demographic changes and increasing healthcare expenditures. The forecast indicates a positive outlook for terazosin manufacturers, with projected revenue growth in both developed and emerging markets[4].

Market Breakup by Segment and Region

The global terazosin market can be segmented by region and by the type of application (BPH and hypertension). The market is dominated by regions with aging populations, such as North America and Europe. However, emerging markets in Asia and Latin America are also showing significant growth due to improving healthcare infrastructure and increasing awareness[4].

Manufacturing and Production Costs

Raw Material Requirements

The production of terazosin involves specific raw materials, the costs of which can fluctuate based on market trends. The price analysis of these feedstocks is crucial for determining the overall production cost. Raw material suppliers play a significant role in maintaining the stability of the supply chain[1][4].

Process Flow and Unit Operations

The manufacturing process of terazosin involves several unit operations, including synthesis, purification, and formulation. Understanding the detailed process flow and mass balance is essential for optimizing production efficiency and reducing costs[1][4].

Utility and Operating Costs

Utility costs, such as energy and water, and operating costs, including labor and maintenance, are significant components of the total production cost. Efficient management of these costs is critical for maintaining profitability[4].

Financial Trajectory

Capital Investments and Project Funding

Setting up a terazosin manufacturing plant requires substantial capital investments. The project economics include detailed analyses of capital investments, project funding, operating expenses, and income and expenditure projections. Investors need to consider fixed and variable costs, direct and indirect costs, and expected ROI and NPV to make informed decisions[1][4].

Revenue and Profit Projections

The revenue from terazosin sales is expected to grow as the market expands. Profit margins are influenced by production costs, pricing strategies, and market competition. Manufacturers need to optimize product pricing to maximize profitability while maintaining market competitiveness[1][4].

Financial Analysis

A comprehensive financial analysis includes a profit and loss account, financial ratios, and cash flow statements. This analysis helps stakeholders understand the financial health of the project and make strategic decisions. Key financial metrics such as gross margin, operating expenses, and net loss are crucial for evaluating the financial trajectory of the project[1][4].

Competitive Landscape

Market Structure

The terazosin market is characterized by a mix of large pharmaceutical companies and smaller generic drug manufacturers. The market structure is competitive, with key players competing on the basis of price, quality, and innovation[4].

Key Players

Major pharmaceutical companies, along with generic drug manufacturers, dominate the terazosin market. These players have significant market strategies, production capacities, and financial resources that influence the market dynamics[4].

Regulatory Frameworks and Sustainability

Regulatory Compliance

Manufacturers must comply with stringent regulatory frameworks to ensure the quality and safety of terazosin. Regulatory compliance is a critical aspect of the production process, and non-compliance can result in significant financial and reputational losses[4].

Environmental and Sustainability Measures

The production of terazosin also involves environmental and sustainability considerations. Manufacturers need to implement sustainable practices to minimize environmental impact and ensure long-term viability[4].

Key Takeaways

• Growing Demand: The market for terazosin is driven by the increasing prevalence of BPH and hypertension, particularly among the aging population.
• Manufacturing Costs: Raw material costs, utility costs, and operating expenses are critical components of the total production cost.
• Financial Projections: Revenue and profit projections are influenced by production costs, pricing strategies, and market competition.
• Competitive Landscape: The market is competitive, with key players competing on price, quality, and innovation.
• Regulatory Compliance: Manufacturers must comply with regulatory frameworks to ensure quality and safety.
• Sustainability: Implementing sustainable practices is essential for minimizing environmental impact and ensuring long-term viability.

FAQs

Q: What are the primary uses of HYTRIN (terazosin)?

A: HYTRIN is primarily used to treat benign prostatic hyperplasia (BPH) and hypertension.

Q: What drives the demand for HYTRIN?

A: The demand for HYTRIN is driven by the increasing prevalence of BPH and hypertension, particularly among the aging population, and growing patient awareness of the importance of managing these conditions.

Q: What are the key components of the production cost of HYTRIN?

A: The key components include raw material costs, utility costs, and operating expenses such as labor and maintenance.

Q: How does the competitive landscape of the terazosin market look?

A: The market is competitive, with a mix of large pharmaceutical companies and smaller generic drug manufacturers competing on the basis of price, quality, and innovation.

Q: What regulatory considerations do manufacturers of HYTRIN need to adhere to?

A: Manufacturers must comply with stringent regulatory frameworks to ensure the quality and safety of the medication.

Sources

1. IMARC Group: Terazosin (Hytrin) Manufacturing Plant Project Report 2024: Industry Trends, Plant Setup, Machinery, Raw Materials, Investment Opportunities, Cost and Revenue.
2. Globenewswire: Hyperfine, Inc. Reports Third Quarter 2024 Financial Results.
3. FDA: HYTRIN - terazosin hydrochloride tablet Abbott Laboratories.
4. Expert Market Research: Terazosin (Hytrin) Manufacturing Plant Project Report 2024 Edition: Industry Trends, Capital Investment, Price Trends, Manufacturing Process, Raw Materials Requirement, Plant Setup, Operating Cost, and Revenue Statistics.
5. Businesswire: Hyliion Holdings Reports Third-Quarter 2024 Financial Results.