PRAZOSIN HYDROCHLORIDE - Generic Drug Details

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

Prazosin hydrochloride is the generic ingredient in three branded drugs marketed by Pfizer, Alembic, Am Therap, Ani Pharms, Appco, Aurobindo Pharma Ltd, Dava Pharms Inc, Granules, Lannett Co Inc, Mankind Pharma, MSN, Mylan, Novitium Pharma, Purepac Pharm, Teva Pharms, and Watson Labs, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for prazosin hydrochloride. Twenty-nine suppliers are listed for this compound.

Summary for PRAZOSIN HYDROCHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	16
NDAs:	25
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	67
Patent Applications:	2,711
What excipients (inactive ingredients) are in PRAZOSIN HYDROCHLORIDE?	PRAZOSIN HYDROCHLORIDE excipients list
DailyMed Link:	PRAZOSIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PRAZOSIN HYDROCHLORIDE

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

Sponsor	Phase
Kinnov Therapeutics	Phase 1
Ottawa Hospital Research Institute	Early Phase 1
The Royal's Institute of Mental Health Research	Early Phase 1

See all PRAZOSIN HYDROCHLORIDE clinical trials

Pharmacology for PRAZOSIN HYDROCHLORIDE

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

Medical Subject Heading (MeSH) Categories for PRAZOSIN HYDROCHLORIDE

Adrenergic alpha-1 Receptor Antagonists

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for PRAZOSIN HYDROCHLORIDE

C02CA	Alpha-adrenoreceptor antagonists
C02C	ANTIADRENERGIC AGENTS, PERIPHERALLY ACTING
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

US Patents and Regulatory Information for PRAZOSIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Appco	PRAZOSIN HYDROCHLORIDE	prazosin hydrochloride	CAPSULE;ORAL	213406-003	Oct 21, 2022	AB	RX	No	No
Appco	PRAZOSIN HYDROCHLORIDE	prazosin hydrochloride	CAPSULE;ORAL	213406-002	Oct 21, 2022	AB	RX	No	No
Alembic	PRAZOSIN HYDROCHLORIDE	prazosin hydrochloride	CAPSULE;ORAL	217268-001	Mar 6, 2023	AB	RX	No	No
Dava Pharms Inc	PRAZOSIN HYDROCHLORIDE	prazosin hydrochloride	CAPSULE;ORAL	072707-001	May 16, 1989		DISCN	No	No
Appco	PRAZOSIN HYDROCHLORIDE	prazosin hydrochloride	CAPSULE;ORAL	213406-001	Oct 21, 2022	AB	RX	No	No
Purepac Pharm	PRAZOSIN HYDROCHLORIDE	prazosin hydrochloride	CAPSULE;ORAL	072992-001	May 16, 1989		DISCN	No	No
Lannett Co Inc	PRAZOSIN HYDROCHLORIDE	prazosin hydrochloride	CAPSULE;ORAL	214083-002	Jan 3, 2024		DISCN	No	No

Expired US Patents for PRAZOSIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	MINIPRESS XL	prazosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019775-002	Jan 29, 1992	5,082,668
Pfizer	MINIPRESS	prazosin hydrochloride	CAPSULE;ORAL	017442-001	Approved Prior to Jan 1, 1982	3,663,706
Pfizer	MINIPRESS XL	prazosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019775-001	Jan 29, 1992	4,783,337
Pfizer	MINIPRESS XL	prazosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019775-002	Jan 29, 1992	4,765,989
Pfizer	MINIPRESS XL	prazosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019775-001	Jan 29, 1992	4,327,725
Pfizer	MINIPRESS	prazosin hydrochloride	CAPSULE;ORAL	017442-003	Approved Prior to Jan 1, 1982	3,511,836
Pfizer	MINIPRESS	prazosin hydrochloride	CAPSULE;ORAL	017442-001	Approved Prior to Jan 1, 1982	3,511,836

PRAZOSIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prazosin Hydrochloride

Introduction

Prazosin hydrochloride, a versatile drug with applications in hypertension, prostate cancer, and other medical conditions, is experiencing significant market dynamics. This article delves into the current market size, growth projections, key drivers, and financial trajectory of prazosin hydrochloride.

Market Size and Growth Projections

The prazosin hydrochloride market has shown substantial growth in recent years and is expected to continue this trend. As of 2023, the market size was valued at several billion USD, with projections indicating it will reach even higher values by 2031, exhibiting a notable compound annual growth rate (CAGR)[1][4].

Segmentation of the Market

The market for prazosin hydrochloride is segmented based on several key factors:

By Type

• Pharmaceutical Grade: This segment is dominant due to the drug's widespread use in medical treatments.
• Industrial Grade: Although smaller, this segment also plays a crucial role in various industrial applications[1].

By Application

• Bases & Related Reagents: Used in chemical synthesis and research.
• Pharmaceuticals: The primary application, including treatment of hypertension and prostate cancer.
• Intermediates & Fine Chemicals: Used in the production of other pharmaceuticals and chemicals[1].

By Geography

• North America: A significant market due to advanced healthcare infrastructure.
• Europe: Another major market with a high demand for pharmaceuticals.
• Asia-Pacific: Rapidly growing due to increasing healthcare needs and economic development.
• South America and Middle-East & Africa: Emerging markets with growing potential[1].

Drivers of Market Growth

Several factors are driving the growth of the prazosin hydrochloride market:

Increasing Prevalence of Hypertension

The global rise in hypertension cases is a major driver, as prazosin hydrochloride is commonly used to treat this condition[5].

Research and Development

The drug's potential in treating prostate cancer and other conditions is being explored, leading to increased demand in research settings[2].

Economic Factors

The cost-effectiveness of prazosin hydrochloride compared to other treatments is another significant driver. For instance, Medicaid saw a 37.8% savings in expenditures on prazosin HCl from 2018 to 2022 due to a decrease in cost per dose-day[3].

Financial Trajectory

The financial performance of the prazosin hydrochloride market is marked by several key trends:

Revenue Growth

The market is expected to grow at a CAGR of around 5.5% during the forecast period, indicating robust revenue growth[4].

Expenditure Trends

Medicaid data shows that while expenditures on prazosin HCl decreased significantly from 2018 to 2022, this was largely due to a reduction in cost per dose-day rather than a decrease in patient numbers. This trend suggests that the drug remains a cost-effective option[3].

Competitive Landscape

The market is characterized by a competitive landscape with key players such as TCI Chemicals, Merck Millipore, Toronto Research Chemicals, and others. These companies are profiled based on their market entry year, product offerings, and other market-related factors[1].

Challenges and Opportunities

Challenges

• Regulatory Environment: Changes in regulatory policies can impact the market.
• Competition from Alternatives: The emergence of new treatments for hypertension and prostate cancer could pose a challenge.
• Economic Fluctuations: Global economic conditions can affect the affordability and accessibility of the drug[1].

Opportunities

• Emerging Markets: Growing healthcare needs in regions like Asia-Pacific and South America present significant opportunities.
• Research and Development: Continued research into new applications of prazosin hydrochloride can expand its market.
• Cost-Effectiveness: The drug's cost-effectiveness makes it an attractive option in cost-sensitive markets[1][4].

Market Outlook

The market outlook for prazosin hydrochloride is positive, driven by its established use in treating hypertension and its potential in other medical applications. Here are some key points:

Porter's 5 Forces Framework

An analysis using Porter's 5 Forces Framework reveals that the market is influenced by factors such as competitive rivalry, threat of new entrants, bargaining power of suppliers and buyers, and the threat of substitute products[1].

Value Chain Analysis

A thorough value chain analysis highlights the importance of efficient supply chain management, research and development, and marketing strategies in maintaining market competitiveness[1].

Pricing Analysis

The pricing of prazosin hydrochloride is critical, with cost reductions and competitive pricing strategies playing a significant role in its market success[1].

"Prazosin HCl is the drug category with the second largest decrease in expenditures. The $2,308,350 savings was created with the $6,099,095 expenditures in 2018 dropped to $3,780,845 in 2022. That 37.8% savings occurred despite a 14.7% increase in patients because the cost per dose-day fell 50.0% from $6 in 2018 to $3 in 2022."[3]

Key Players

The market is dominated by several key players:

• TCI Chemicals
• Merck Millipore
• Toronto Research Chemicals
• Cayman Chemical
• R&D Systems
• Axon MedChem BV

These companies are profiled in detail, including their market entry year and various market-related factors[1].

Conclusion

The prazosin hydrochloride market is poised for significant growth, driven by its established medical applications and potential in new areas. The market's financial trajectory is marked by revenue growth, cost-effectiveness, and a competitive landscape. As the healthcare sector continues to evolve, prazosin hydrochloride is likely to remain a vital component.

Key Takeaways

• The prazosin hydrochloride market is expected to grow significantly by 2031.
• The market is segmented by type, application, and geography.
• Key drivers include the increasing prevalence of hypertension and research into new applications.
• The financial trajectory is characterized by revenue growth and cost-effectiveness.
• Challenges include regulatory changes and competition from alternatives.
• Opportunities lie in emerging markets and continued research.

FAQs

What is the primary use of prazosin hydrochloride?

Prazosin hydrochloride is primarily used to treat high blood pressure (hypertension) and can also be used for other conditions such as prostate cancer.

Which regions are the largest markets for prazosin hydrochloride?

North America and Europe are significant markets, but the Asia-Pacific region is also growing rapidly.

What are the key drivers of the prazosin hydrochloride market?

The increasing prevalence of hypertension, research and development into new applications, and the drug's cost-effectiveness are major drivers.

How has the cost of prazosin hydrochloride impacted its market?

The cost per dose-day of prazosin hydrochloride has decreased significantly, leading to cost savings and making it a more attractive option.

Who are the key players in the prazosin hydrochloride market?

Key players include TCI Chemicals, Merck Millipore, Toronto Research Chemicals, Cayman Chemical, R&D Systems, and Axon MedChem BV.

Sources

1. Market Research Intellect: Prazosin Hydrochloride Market Size, Scope And Forecast Report.
2. Tocris Bioscience: Prazosin hydrochloride.
3. New Hampshire Department of Health and Human Services: Prescription Drug Affordability Board - 2023 Annual Report.
4. DataIntelo: Prazosin Hydrochloride (CAS 19237-84-4) Market Research Report.
5. Mayo Clinic: Prazosin (oral route).