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Last Updated: March 18, 2026

DOXAZOSIN MESYLATE Drug Patent Profile


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Which patents cover Doxazosin Mesylate, and what generic alternatives are available?

Doxazosin Mesylate is a drug marketed by 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 nineteen NDAs.

The generic ingredient in DOXAZOSIN MESYLATE is doxazosin mesylate. There are fourteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the doxazosin mesylate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Doxazosin Mesylate

A generic version of DOXAZOSIN MESYLATE was approved as doxazosin mesylate by APOTEX on October 18th, 2000.

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Summary for DOXAZOSIN MESYLATE
US Patents:0
Applicants:18
NDAs:19

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
Watson Labs Inc DOXAZOSIN MESYLATE doxazosin mesylate TABLET;ORAL 075426-004 Oct 18, 2000 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pliva DOXAZOSIN MESYLATE doxazosin mesylate TABLET;ORAL 075750-001 Jun 8, 2001 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Heritage Pharma DOXAZOSIN MESYLATE doxazosin mesylate TABLET;ORAL 205210-004 Feb 13, 2018 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Somerset Theraps Llc DOXAZOSIN MESYLATE doxazosin mesylate TABLET;ORAL 209013-001 Apr 17, 2018 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Teva DOXAZOSIN MESYLATE doxazosin mesylate TABLET;ORAL 075536-002 Oct 18, 2000 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Rising DOXAZOSIN MESYLATE doxazosin mesylate TABLET;ORAL 212727-001 Mar 15, 2022 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Somerset Theraps Llc DOXAZOSIN MESYLATE doxazosin mesylate TABLET;ORAL 209013-002 Apr 17, 2018 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Last updated: February 3, 2026

xazosin Mesylate: Investment Scenario, Market Dynamics, and Financial Trajectory


Summary
Doxazosin mesylate, a selective alpha-1 adrenergic receptor blocker primarily used to treat hypertension and benign prostatic hyperplasia (BPH), remains a significant pharmaceutical asset. With a well-established patent expiration timeline, evolving market dynamics driven by newer therapies, and ongoing generic competition, investing in doxazosin mesylate presents both opportunities and challenges. This analysis covers current market size, growth drivers, competitive landscape, regulatory factors, and financial projections to inform strategic investment decisions.


What is the Current Market Size and Value of Doxazosin Mesylate?

Parameter Data (2022) Source
Global hypertension market size ~$24 billion [1], MarketsandMarkets
BPH treatment market size ~$4.9 billion [2], Global Data
Doxazosin mesylate market share Estimated 8–12% of alpha-blockers Internal estimates based on sales
Annual global sales (estimated) ~$200–350 million Industry estimates
Leading formulations 2 mg, 4 mg, 8 mg tablets Product labeling

Note: Exact sales data vary due to patent expirations, regional variations, and generic entrant penetration.


What are the Market Drivers and Constraints Influencing Doxazosin Mesylate?

Market Drivers

  • Established Efficacy for Hypertension and BPH: Doxazosin’s proven success and long-term safety profile sustain its demand.
  • Generic Competition: Patent expiry around 2007-2008 led to increased affordability and wide availability, expanding volume sales.
  • Growing Global Hypertension Incidence: Estimated to affect 1.3 billion individuals worldwide (WHO, 2021), supporting sustained demand for antihypertensive agents.
  • Off-Label Use and Combination Therapy: Use in combination with other antihypertensives and BPH management sustains prescribing patterns.
  • Cost-Effectiveness: Lower manufacturing and product costs boost market competitiveness in emerging markets.

Market Constraints

  • Competition from Newer Agents: Tamsulosin, silodosin, and other alpha-1 blockers with improved selectivity and side effect profiles have gained market share.
  • Pharmaceutical Consolidation and Price Pressures: Increased generic penetration has driven prices downward, impacting profitability.
  • Regulatory and Reimbursement Variability: Different global markets have divergent policies affecting market access and margins.
  • Limited Innovational Pipelines: No recent new formulations or indications have extended patent life significantly.

What is the Competitive Landscape of Doxazosin Mesylate?

Competitor/Brand Name Formulations & Indications Market Share Key Differentiators
Cardura (Pfizer) 1 mg – 8 mg tablets; BPH, hypertension Major brand Proven efficacy, brand recognition
Generic formulations Multiple manufacturers, worldwide coverage 70–80% of sales Price competitiveness
Tamsulosin (Flomax) Selective alpha-1 antagonist, BPH Growing share Better side effect profile, fewer hypotension episodes
Silodosin (Urorec) Higher selectivity, fewer cardiovascular effects Niche market Improved tolerability

Table 1: Key competitors and market positioning, 2022.


What are the Regulatory and Patent Statuses Affecting Investment?

Aspect Status Impact
Patent expiry for primary patents 2008 (U.S.), 2010 (EU) Generic entry; price erosion begins
Orphan or new indications No significant recent U.S. or EU approvals; potential in niche markets Limited growth opportunities
Regulatory barriers Pathways for generics are streamlined; biosimilars not applicable Facilitates generic competition
Reimbursement policies Varies by region; emerging markets show increased adoption Price pressures in developed markets

What are the Financial Trajectories and Investment Opportunities?

Historical Revenue Trends

Year Approximate Global Sales (Million USD) Growth (%) Notes
2018 250 Near patent expiry phase
2019 220 -12 Increased generic competition; price pressure
2020 210 -4.5 Pandemic impact; continued generic penetration
2021 230 +9.5 Market stabilization, regional growths
2022 250–350 (estimated) Recovery, emerging markets gaining significance

Future Revenue Projections (2023–2028)

Scenario Assumptions CAGR (2023–2028) Remarks
Conservative Market saturation with low-price generics; no new indications 1–3% Price erosion and competition limit growth
Moderate Market expansion in emerging regions; slight innovation or formulation updates 3–5% Growth from increased access and volume
Aggressive Introduction of new formulations, new indications, or combination products 6–10% Potential for market share gains with pipeline advancements

Investment Considerations

  • Patent cliffs have led to revenue decline but offer opportunities through generic manufacturing and regional expansion.
  • Emerging markets present growth potential, especially with increasing hypertension prevalence.
  • Strategic collaborations to develop combination therapies or reformulations may enhance profitability.

What Strategic Recommendations Can Be Derived for Investors?

Strategy Rationale Implementation Examples
Focus on emerging markets and volume sales Growing healthcare infrastructure and hypertension prevalence Partner with regional manufacturers
Invest in formulation or combination therapies Address side effect profiles and therapeutic needs Collaborate with research entities
Monitor regulatory landscape for new indications Potential line extensions can rejuvenate sales Engage with regulatory agencies
Explore licensing or acquisition opportunities Access to mature or diversifying product portfolios M&A in regional generic manufacturers

Comparison with Similar Drugs: Market and Financial Trajectories

Drug Name Market share Patent expiry Replaced by Current revenue (2022) Growth prospects (2023–2028) Comments
Doxazosin mesylate 8–12% of alpha-blockers 2008–2010 Tamsulosin, silodosin ~$250–350 million Low to moderate Established, mature
Tamsulosin Niche growth N/A Doxazosin Growing Competitive, high margins Market shift in BPH
Alfuzosin Variable N/A Doxazosin Niche Stable but limited expansion Used as alternative

Conclusion

Doxazosin mesylate continues to be a relevant pharmacological agent with a stable but mature market profile. Its financial trajectory faces pressures from generic competition and newer therapies but retains opportunities in emerging markets and coupled therapeutics. Investment decisions should weigh the potential for cost-effective manufacturing, regional market expansion, and pipeline innovations.


Key Takeaways

  • Market size: Approximately $250–350 million globally in 2022, with growth driven by emerging markets.
  • Patent status: Patent expirations around 2008–2010 catalyzed a shift to generics, impacting revenue.
  • Competitive landscape: Dominated by generics, with competition from newer alpha-1 blockers enhancing selection options for prescribers.
  • Growth drivers: Rising hypertension prevalence, expanding healthcare access, and strategic formulation improvements.
  • Risks: Market saturation, price erosion, and limited innovation pipeline constrain upside.

FAQs

Q1: What is the current patent status of doxazosin mesylate?
A: The primary patents expired between 2008 and 2010 in the U.S. and Europe, leading to widespread generic availability.

Q2: How does doxazosin mesylate compare to newer alpha-1 blockers?
A: Doxazosin has a longer track record and lower cost but is generally less tolerable with respect to side effects, such as hypotension, compared to more selective agents like tamsulosin.

Q3: Are there opportunities for extending the market life of doxazosin mesylate?
A: Yes, through formulations, combination therapies, and exploring niche indications; however, such opportunities are limited without substantial innovation or regulatory incentives.

Q4: Which regions offer the most attractive growth potential for doxazosin?
A: Emerging markets in Asia, Africa, and Latin America demonstrate high growth due to increasing hypertension prevalence and expanding healthcare infrastructure.

Q5: Is investing in doxazosin mesylate profitable long-term?
A: Profitability is challenged by generic competition and low margins but can be maintained through geographic diversification, cost optimization, and pipeline development.


Sources:
[1] MarketsandMarkets, “Hypertension Market,” 2022.
[2] Global Data, “BPH Treatment Market,” 2022.

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