DOXAZOSIN MESYLATE - Generic Drug Details

What are the generic drug sources for doxazosin mesylate and what is the scope of freedom to operate?

Doxazosin mesylate is the generic ingredient in three branded drugs marketed by Viatris, Accord Hlthcare, Actavis Elizabeth, Ani Pharms, Apotex, Aurobindo Pharma Usa, Chartwell Rx, Genpharm, Heritage Pharma, Ivax Sub Teva Pharms, Nesher Pharms, Pliva, Rising, Strides Pharma, Teva, Unichem, Upsher Smith Labs, Watson Labs Inc, and Zydus Pharms, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for doxazosin mesylate. Thirty-two suppliers are listed for this compound.

Summary for DOXAZOSIN MESYLATE

US Patents:	0
Tradenames:	3
Applicants:	19
NDAs:	21
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	32
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	2
Patent Applications:	3,094
Drug Prices:	Drug price trends for DOXAZOSIN MESYLATE
What excipients (inactive ingredients) are in DOXAZOSIN MESYLATE?	DOXAZOSIN MESYLATE excipients list
DailyMed Link:	DOXAZOSIN MESYLATE at DailyMed

See drug prices for DOXAZOSIN MESYLATE

See drug sales revenues for DOXAZOSIN MESYLATE

Recent Clinical Trials for DOXAZOSIN MESYLATE

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

Sponsor	Phase
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
National Heart, Lung, and Blood Institute (NHLBI)	Phase 2

See all DOXAZOSIN MESYLATE clinical trials

Pharmacology for DOXAZOSIN MESYLATE

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

Medical Subject Heading (MeSH) Categories for DOXAZOSIN MESYLATE

Adrenergic alpha-1 Receptor Antagonists

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for DOXAZOSIN MESYLATE

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

US Patents and Regulatory Information for DOXAZOSIN MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	DOXAZOSIN MESYLATE	doxazosin mesylate	TABLET;ORAL	075432-001	Oct 18, 2000		DISCN	No	No
Upsher Smith Labs	DOXAZOSIN MESYLATE	doxazosin mesylate	TABLET;ORAL	209013-001	Apr 17, 2018	AB	RX	No	No
Teva	DOXAZOSIN MESYLATE	doxazosin mesylate	TABLET;ORAL	075353-004	Jan 12, 2001		DISCN	No	No

Expired US Patents for DOXAZOSIN MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-004	Nov 2, 1990
Viatris	CARDURA XL	doxazosin mesylate	TABLET, EXTENDED RELEASE;ORAL	021269-002	Feb 22, 2005
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-003	Nov 2, 1990

DOXAZOSIN MESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Doxazosin Mesylate

Introduction to Doxazosin Mesylate

Doxazosin mesylate, marketed under the brand name CARDURA, is a quinazoline compound that acts as a selective inhibitor of the alpha1 subtype of alpha-adrenergic receptors. It is primarily used to treat hypertension and benign prostatic hyperplasia (BPH)[5].

Market Growth and Projections

The global doxazosin mesylate market is experiencing significant growth, driven by the increasing prevalence of hypertension and BPH.

• Market Size and Growth Rate: The market is projected to grow at a CAGR of 10.2%, reaching a market size of USD 2,487.21 million by 2030, up from the current valuation of USD 1,298.45 million[1].
• Alternative Projections: Some reports suggest a more conservative growth rate of 3 to 5% CAGR, but still indicate a substantial increase in market size over the next decade[4].

Key Drivers of Market Growth

Several factors are contributing to the robust growth of the doxazosin mesylate market:

• Increasing Prevalence of Hypertension and BPH: The rising incidence of these conditions, particularly among the aging population, is driving the demand for effective treatments like doxazosin mesylate[1].
• Advancements in Healthcare Infrastructure: Improvements in healthcare facilities and access to medical services in various regions are enhancing the market's potential[1].
• Government Policies and Regulatory Support: Favorable regulatory environments and government initiatives to improve healthcare outcomes are also boosting the market[1].

Market Segmentation

The doxazosin mesylate market is segmented based on several criteria:

• Applications: Hypertension, heart attack, kidney problems, benign prostatic hyperplasia, and others[1].
• Type: Doxazosin mesylate tablets and capsules[1].
• End User: Hospitals & clinics, ambulatory surgical centers[1].
• Geographical Regions: North America, South America, Europe, Asia Pacific, and Middle East & Africa[1][4].

Regional Market Analysis

The market is distributed across various regions, each with its own growth dynamics:

• North America: This region is a significant market due to high healthcare spending and advanced medical infrastructure. The U.S., Canada, and Mexico are key countries in this segment[1].
• Europe: Countries like Germany, France, Italy, and the UK drive the European market, which is also influenced by strong healthcare systems and regulatory support[1].
• Asia Pacific: This region is expected to see rapid growth due to the large population and increasing healthcare needs in countries such as China, Japan, India, and South Korea[1].
• South America and MEA: These regions are also growing, albeit at a slower pace, due to improving healthcare access and economic conditions[1].

Competitive Landscape

The doxazosin mesylate market is highly competitive, with several key players:

• Pfizer Inc.
• Upsher-Smith Laboratories
• Zydus Pharmaceuticals
• Heritage Pharmaceuticals
• Accord Healthcare
• Par Pharmaceuticals
• APOTEX
• Hefei Lifeon Pharmaceutical
• Shandong ShanChuan Pharmaceutical
• Kangmei Pharmaceutical
• Zhejiang CONBA Pharmaceutical
• Reddy Laboratory
• **Viatris Inc.[1][4].

Pharmacokinetics and Clinical Significance

Understanding the pharmacokinetics of doxazosin mesylate is crucial for its clinical use:

• Metabolism and Excretion: Doxazosin is extensively metabolized, with only about 5% of the administered dose excreted unchanged in urine. It has a terminal elimination half-life of approximately 22 hours[2][5].
• Bioavailability: Oral bioavailability is about 65%, and the drug is highly bound to plasma proteins (98.3%)[2][5].
• Clinical Effects: Doxazosin produces significant reductions in blood pressure and is suitable for once-daily administration. It also has small effects on serum cholesterol levels[5].

Regulatory and Safety Considerations

• Orthostatic Hypotension: A key safety concern is the risk of orthostatic hypotension, particularly in patients taking higher doses. This requires careful monitoring and patient education[5].
• Government Policies: Regulatory support and guidelines play a crucial role in the market's growth and the safe use of doxazosin mesylate[1].

Market Entry Strategies and Value Chain Analysis

New entrants into the market need to consider several strategies:

• Market Entry: Understanding the competitive landscape, regulatory environment, and market demand is essential for successful market entry[1].
• Value Chain Analysis: This involves analyzing the entire supply chain from raw material sourcing to end-user delivery to optimize costs and efficiency[1].

Impact of Macro-Economic Factors

Macro-economic factors such as economic growth, healthcare spending, and demographic changes significantly impact the market:

• Economic Growth: Economic stability and growth in various regions can increase healthcare spending and demand for pharmaceuticals like doxazosin mesylate[1].
• Demographic Changes: An aging population increases the prevalence of conditions treated by doxazosin mesylate, driving market growth[1].

Key Takeaways

• The doxazosin mesylate market is expected to grow significantly, driven by increasing prevalence of hypertension and BPH.
• The market is segmented by application, type, end user, and geographical region.
• Key players dominate the market, and new entrants must consider competitive strategies and regulatory environments.
• Pharmacokinetic properties support once-daily dosing, but safety considerations like orthostatic hypotension must be managed.

FAQs

Q: What is the projected growth rate of the doxazosin mesylate market? A: The market is expected to grow at a CAGR of 10.2% until 2030[1].

Q: Which regions are key markets for doxazosin mesylate? A: North America, Europe, Asia Pacific, South America, and Middle East & Africa are the primary regions[1][4].

Q: What are the main applications of doxazosin mesylate? A: The main applications include hypertension, heart attack, kidney problems, and benign prostatic hyperplasia[1].

Q: Who are the major players in the doxazosin mesylate market? A: Major players include Pfizer Inc., Upsher-Smith Laboratories, Zydus Pharmaceuticals, and others[1][4].

Q: What is the terminal elimination half-life of doxazosin mesylate? A: The terminal elimination half-life of doxazosin mesylate is approximately 22 hours[2][5].

Cited Sources

1. HTF Market Intelligence: Global Doxazosin Mesylate Market Growing High for Next Decade Return.
2. PubMed: Pharmacokinetic overview of doxazosin.
3. Stats and Data: Global Doxazosin Mesylate Tablets Market Technological ...
4. Market Research Intellect: Global Doxazosin Mesylate Market Size And Forecast.
5. FDA: CARDURA® (doxazosin mesylate) Tablets DESCRIPTION.