Alfuzosin hydrochloride - Generic Drug Details

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

Alfuzosin hydrochloride is the generic ingredient in two branded drugs marketed by Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Invagen Pharms, Pharmobedient, Sun Pharm, Torrent Pharms, Unichem, Wockhardt Bio Ag, and Advanz Pharma, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for alfuzosin hydrochloride. Eleven suppliers are listed for this compound.

Summary for alfuzosin hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	48
Patent Applications:	452
What excipients (inactive ingredients) are in alfuzosin hydrochloride?	alfuzosin hydrochloride excipients list
DailyMed Link:	alfuzosin hydrochloride at DailyMed

Recent Clinical Trials for alfuzosin hydrochloride

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

Sponsor	Phase
Pharma Nueva	PHASE1
International Bio service	PHASE1
AJU Pharm Co., Ltd.	PHASE4

See all alfuzosin hydrochloride clinical trials

Pharmacology for alfuzosin hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for alfuzosin hydrochloride

G04CA	Alpha-adrenoreceptor antagonists
G04C	DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for ALFUZOSIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
UROXATRAL	Extended-release Tablets	alfuzosin hydrochloride	10 mg	021287	9	2007-06-12

US Patents and Regulatory Information for alfuzosin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	ALFUZOSIN HYDROCHLORIDE	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079057-001	Jul 18, 2011		DISCN	No	No
Aurobindo Pharma Ltd	ALFUZOSIN HYDROCHLORIDE	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079060-001	Aug 30, 2012	AB	RX	No	No
Wockhardt Bio Ag	ALFUZOSIN HYDROCHLORIDE	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090221-001	Aug 10, 2012		DISCN	No	No
Chartwell Rx	ALFUZOSIN HYDROCHLORIDE	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079056-001	Jul 18, 2011		DISCN	No	No

Expired US Patents for alfuzosin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Advanz Pharma	UROXATRAL	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021287-001	Jun 12, 2003
Advanz Pharma	UROXATRAL	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021287-001	Jun 12, 2003

Market Dynamics and Financial Trajectory for Alfuzosin Hydrochloride

Last updated: July 27, 2025

Introduction

Alfuzosin Hydrochloride, a selective alpha-1 adrenergic receptor antagonist, is primarily prescribed for the management of benign prostatic hyperplasia (BPH). Since its approval, the drug has carved out a significant niche within Urology therapeutics owing to its efficacy and favorable side-effect profile. Analyzing the market dynamics and financial trajectory of Alfuzosin Hydrochloride unveils key opportunities and challenges shaping its future landscape.

Pharmacological Profile and Therapeutic Significance

Alfuzosin Hydrochloride acts by relaxing smooth muscle tissue in the prostate and bladder neck, thereby improving urine flow in BPH patients. Its selectivity minimizes cardiovascular side effects associated with non-selective alpha-blockers, increasing patient compliance [1].

The drug's favorable safety profile and proven efficacy have facilitated its widespread adoption, especially in regions prioritizing outpatient BPH management solutions. Its once-daily dosing compliance further enhances its market appeal amid growing patient preferences for convenience.

Market Dynamics

Global and Regional Market Landscape

The Alfuzosin Hydrochloride market is predominantly influenced by regional healthcare infrastructure, regulatory approval status, and epidemiological trends of BPH. North America remains the largest market, driven by high prevalence rates of BPH among aging men, advanced healthcare systems, and high awareness levels [2]. The European market follows, benefiting from extensive clinical practice adoption and robust reimbursement frameworks.

Emerging markets in Asia-Pacific demonstrate promising growth due to increasing aging populations and rising healthcare expenditures. Countries like China and India are witnessing a surge in pharmaceutical R&D investments, broadening access to BPH therapeutics, including Alfuzosin.

Market Drivers

• Aging Population: The global demographic shift towards an older population significantly heightens BPH prevalence, thereby augmenting demand for effective therapeutics like Alfuzosin.

• Increased Diagnosis and Awareness: Improved screening protocols and increased awareness about BPH management have led to earlier diagnosis, expanding the treated patient base.

• Product Innovation and Extended Indications: Ongoing clinical trials exploring Alfuzosin's off-label uses or combination therapies could further augment its market, provided regulatory approvals are obtained.

• Pricing and Reimbursement Strategies: Competitive pricing and favorable reimbursement policies in developed markets boost accessibility and sales volumes.

Market Challenges

• Generic Competition: Patent expirations and market entry of generic formulations depress prices and erode profit margins.

• Regulatory Barriers: Varying approval processes and strict clinical trial requirements can delay market penetration, particularly in emerging markets.

• Patient Preferences and Market Penetration: The proliferation of alternative treatments, including minimally invasive procedures, has somewhat constrained pharmaceutical sales.

• Supply Chain Disruptions: Raw material sourcing for active pharmaceutical ingredients (APIs), especially amid geopolitical uncertainties, can hamper manufacturing and supply stability.

Competitive Landscape

The Alfuzosin market is characterized by a mix of branded formulations, generic products, and evolving combination therapies. Major pharmaceutical players like Sanofi, Boehringer Ingelheim, and Indian generic manufacturers dominate the landscape.

The entry of generic Alfuzosin formulations following patent expiries intensified price competition dramatically, leading to price erosion but expanding access globally. Strategic alliances and patent litigations continue to shape competitive dynamics.

Financial Trajectory

Revenue Trends

Historically, Alfuzosin Hydrochloride has demonstrated steady revenue growth, nurtured by expanding indications, demographics, and regional penetration. The global BPH drug market valuation, estimated at USD 5.6 billion in 2022 [3], underscores its significance.

In developed markets, annual growth rates have ranged between 3-5%, reflecting saturation and competitive pressures. Conversely, emerging markets present growth potential exceeding 8%, driven by increased adoption.

Impact of Patent Expiry & Generics

The expiration of primary patents in key regions has led to a decline in branded drug prices while simultaneously increasing overall market size through generic proliferation. Companies focusing on cost-effective manufacturing and broad access have experienced volume-driven revenue boosts.

Research & Development Investment

Investment in next-generation alpha-1 blockers and combination therapies influences future revenue streams. Ongoing clinical research targeting improved safety and multitherapeutic efficacy could spawn new patents, extending product lifecycle and opening additional revenue avenues.

Regulatory and Policy Influence

Regulatory policies impacting drug approval, reimbursement, and pricing in different jurisdictions directly influence Alfuzosin's financial outlook. For instance, the U.S. FDA’s evolving stance on generic drug approvals and pricing regulations in Europe affect market share and profitability.

Market Penetration and Expansion Strategies

Proactive marketing, patient education, and strategic partnerships with healthcare providers are critical for expanding Alfuzosin's market footprint. Moreover, the development of combination drugs—e.g., Alfuzosin with phosphodiesterase inhibitors—may unlock new revenue domains.

Future Outlook

The Alfuzosin Hydrochloride market is poised for stable growth, primarily fueled by demographic trends and ongoing clinical research. However, competitive pressures, regulatory hurdles, and market saturation in developed regions necessitate innovation and strategic agility. Manufacturers investing in formulation improvements, combination therapies, and expanding indications will likely outperform peers.

Conclusion

Alfuzosin Hydrochloride remains a cornerstone in BPH management, displaying a resilient market trajectory bolstered by demographic and technological drivers. The evolving landscape— characterized by generic entries, innovation, and regional expansion—requires players to adapt swiftly. Strategic focus on R&D, pricing, and market access will be decisive in shaping its financial trajectory in the coming decade.

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Key Takeaways

• The global Alfuzosin Hydrochloride market is driven by aging populations and increased BPH awareness, leading to sustained demand.
• Patent expiries have facilitated widespread generic competition, resulting in price adjustments but increased volume sales.
• Emerging markets offer significant growth opportunities due to rising healthcare investments and demographic shifts.
• Continued innovation and combination therapies will be essential to extend product lifecycles and capture new revenue streams.
• Regulatory landscapes and reimbursement policies critically influence market access, pricing strategies, and revenue potential.

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FAQs

Q1. What factors contribute to the growth of Alfuzosin Hydrochloride in emerging markets?
A1. Rising aging populations, increasing healthcare expenditure, improved awareness of BPH, and expanding access to affordable generic alternatives underpin growth in emerging markets.

Q2. How do patent expiries affect Alfuzosin Hydrochloride’s market dynamics?
A2. Patent expiries lead to generic entries, reducing prices and profit margins but increasing overall market volume and accessibility.

Q3. What are the main challenges facing Alfuzosin Hydrochloride’s market expansion?
A3. Challenges include intense generic competition, regulatory hurdles in various jurisdictions, market saturation in developed regions, and raw material supply disruptions.

Q4. Which innovations could influence Alfuzosin Hydrochloride’s future市场?
A4. Development of combination therapies, extended-release formulations, and new indications could prolong market relevance and drive revenue.

Q5. How significant is the role of regulatory agencies in shaping the financial trajectory of Alfuzosin Hydrochloride?
A5. Regulatory approvals, pricing policies, and reimbursement decisions directly impact product availability, pricing strategies, and overall financial performance.

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Sources
[1] Singh, K. et al., "Efficacy and Safety of Alfuzosin in BPH," Urology Journal, 2021.
[2] Grand View Research, "Benign Prostatic Hyperplasia Market Size & Trends," 2022.
[3] MarketsandMarkets, "Urology Drugs Market," 2022.