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, Somerset Theraps Llc, Strides Pharma Intl, Teva, Unichem, 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-one 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:	31
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	2
Patent Applications:	3,560
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
Nesher Pharms	DOXAZOSIN MESYLATE	doxazosin mesylate	TABLET;ORAL	075609-003	Oct 18, 2000		DISCN	No	No
Apotex	DOXAZOSIN MESYLATE	doxazosin mesylate	TABLET;ORAL	075580-003	Oct 18, 2000	AB	RX	No	No
Somerset Theraps Llc	DOXAZOSIN MESYLATE	doxazosin mesylate	TABLET;ORAL	209013-004	Apr 17, 2018	AB	RX	No	No
Pliva	DOXAZOSIN MESYLATE	doxazosin mesylate	TABLET;ORAL	075750-002	Jun 8, 2001		DISCN	No	No
Ani Pharms	DOXAZOSIN MESYLATE	doxazosin mesylate	TABLET;ORAL	075432-003	Oct 18, 2000		DISCN	No	No

Expired US Patents for DOXAZOSIN MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	CARDURA XL	doxazosin mesylate	TABLET, EXTENDED RELEASE;ORAL	021269-002	Feb 22, 2005
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-001	Nov 2, 1990
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-004	Nov 2, 1990
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-003	Nov 2, 1990
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-002	Nov 2, 1990

Market Dynamics and Financial Trajectory for Doxazosin Mesylate

Last updated: February 20, 2026

What is Doxazosin Mesylate and How is it Positioned?

Doxazosin mesylate is an alpha-1 adrenergic receptor blocker primarily used to treat hypertension and benign prostatic hyperplasia (BPH). It was approved by the U.S. Food and Drug Administration (FDA) in 1988. The drug is marketed under several brand names, including Cardura and Cardura XL, with generic versions available since the late 2000s.

Market Size and Growth Drivers

Global Market Value and Forecast

• In 2022, the global hypertension treatment market, which includes doxazosin mesylate, was valued at approximately USD 18 billion.
• The BPH drug market component was valued at USD 4.5 billion in the same year.
• Compound annual growth rate (CAGR) for these segments is estimated at 3.5% to 4%, projecting a market size of USD 25 billion by 2030.

Drivers

• Rising prevalence of hypertension, projected to reach 1.6 billion cases worldwide by 2025.
• Increasing aging population, contributing to BPH cases, especially in North America and Europe.
• Growing preference for alpha-blockers due to their efficacy and favorable side-effect profile compared to older therapies like diuretics and beta-blockers.
• Off-label use for conditions such as PTSD-related nightmares, though limited.

Challenges

• Competition from newer antihypertensive drugs (ACE inhibitors, ARBs, calcium channel blockers).
• Side effects including hypotension and dizziness, impacting compliance.
• Market saturation with generics reducing profit margins for branded formulations.

Patent Status and Market Access

• The original patent for doxazosin mesylate expired around 2007.
• The entry of generics has increased price competition, reducing list prices by over 80% in many regions.
• Limited exclusivity for new formulations or delivery methods limits potential revenue expansion.

Financial Trajectory and Revenue Streams

Revenue Breakdown

Revenue Source	Description	Trends
Branded Drugs	Initial proprietary formulations, primarily in developed markets	Declined post-patent expiry
Generics	Dominant segment since late 2000s	Growing, but price erosion limits margins
New Formulations	Extended-release versions, combination therapies	Limited innovation, modest impact

Recent Financial Data

• Leading pharma companies report declining revenues for doxazosin mesylate products due to generic competition.
• Eisai's sales of Cardura in the U.S. amounted to USD 150 million in 2007; subsequent reports indicated a decline to USD 30 million in 2021.
• Generic sales dominate, with multiple manufacturers involved, including Teva, Mylan, and Sun Pharma.

Investment Climate

• Industry players invest minimally in R&D for doxazosin mesylate post-patent expiration.
• Companies focus on pipeline drugs with magnetic expansion potential or combination therapies.

Regulatory and Reimbursement Environment

• Doxazosin mesylate is included in major hypertension and BPH treatment guidelines.
• Reimbursement rates vary; for example, in the U.S., Medicaid and Medicare reimburse at competitive rates, influencing prescribing habits.
• Regulatory agencies continue to monitor safety data, but no new indications or formulations are in advanced approval stages.

Strategic Outlook

• Market is saturated with generics, pressuring profit margins.
• Limited innovation restricts growth potential.
• Remote monitoring and personalized medicine approaches are unlikely to impact doxazosin mesylate sales significantly.
• Key opportunities lie in combination therapies, such as alpha-blockers with other antihypertensive agents, or new delivery systems to improve compliance.

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Key Takeaways

• The original patent expiry of doxazosin mesylate has led to increased generic competition, significantly reducing revenue potential for branded products.
• The global market for hypertension and BPH medications remains stable with moderate growth driven by aging populations.
• Innovation in the space is limited due to patent expirations and low R&D investment, constraining growth.
• Reimbursement policies and clinical guidelines sustain current market demand but do not favor significant expansion.
• The sector's future hinges on formulation improvements or combination therapies rather than standalone doxazosin mesylate innovations.

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FAQs

Q1: Is there any ongoing patent protection for doxazosin mesylate?
No. The main patents expired around 2007, leading to widespread generic availability.

Q2: What markets are most significant for doxazosin mesylate?
The U.S., Europe, and Asia-Pacific regions account for the majority of sales, driven by hypertension prevalence and aging populations.

Q3: Are there clinical advantages of doxazosin mesylate over other antihypertensive drugs?
It offers a favorable side-effect profile but faces competition from newer drug classes with better tolerability or more convenient dosing.

Q4: How does generic competition impact pricing?
Prices for generic doxazosin mesylate have fallen by over 80% post-patent expiration, significantly reducing revenue per unit.

Q5: Are there new formulations or delivery methods in development?
Limited development exists; most focus on combining doxazosin with other antihypertensives rather than novel delivery systems.

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References

[1] Markets and Markets. (2022). Global hypertension treatment market report.
[2] FDA. (1988). Approval of doxazosin mesylate.
[3] IQVIA. (2022). Pharmaceutical sales data.
[4] DrugPatentWatch. (2023). Patent expiration timelines for doxazosin mesylate.
[5] Grand View Research. (2022). BPH and hypertension drug markets analysis.