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
OM Pharma SA	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
Unichem	ALFUZOSIN HYDROCHLORIDE	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	203192-001	Jan 28, 2016	AB	RX	No	No
Apotex Inc	ALFUZOSIN HYDROCHLORIDE	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079013-001	Jul 18, 2011	AB	RX	No	No
Wockhardt Bio Ag	ALFUZOSIN HYDROCHLORIDE	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090221-001	Aug 10, 2012		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	4,661,491*PED
Advanz Pharma	UROXATRAL	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021287-001	Jun 12, 2003	6,149,940*PED

ALFUZOSIN HYDROCHLORIDE Market Analysis and Financial Projection

Last updated: February 11, 2026

What Are the Current Market Dynamics for Alfuzosin Hydrochloride?

Alfuzosin hydrochloride is primarily marketed for benign prostatic hyperplasia (BPH). It is a selective alpha-1 adrenergic receptor blocker that relaxes muscles in the prostate and bladder neck, improving urine flow.

Market Structure

The global BPH treatment market, including alfuzosin, is characterized by high competition among generic brands and a few branded products. The therapy landscape is dominated by alpha-blockers such as tamsulosin, doxazosin, and terazosin, with alfuzosin occupying a niche due to its selectivity and side-effect profile.

Market Size and Growth

The global BPH drugs market was valued at approximately $4.8 billion in 2021. The alpha-blocker segment accounts for about 60% of this, translating to roughly $2.88 billion. Alfuzosin's market share within this is estimated at 10-15%, with sales around $290 million to $430 million globally in 2022.

The market is projected to grow at a compound annual growth rate (CAGR) of 4-6% through 2028, driven by increasing aging populations, higher prevalence of BPH, and a preference for minimally invasive treatments.

Regional Dynamics

• North America: Largest regional share due to high BPH prevalence among men aged over 50 and advanced healthcare infrastructure.

• Europe: Similar to North America, with evolving prescribing patterns favoring uroselective alpha-blockers.

• Asia-Pacific: Rapid growth expected, owing to increasing healthcare expenditure and expanding aging demographics.

Competitive Landscape

Market leaders include Essilor (for branded formulations), and several generics manufacturers operating in India, China, and Europe. Major players such as Teva Pharmaceutical and Sun Pharmaceutical have both generic alfuzosin products.

Key Factors Influencing Market Dynamics

• Pricing and Reimbursement: Generics lead to lower prices and wider access.
• Regulatory Approvals: Patents for specific formulations influence market exclusivity.
• Physician Prescribing Patterns: Preference for uroselective agents impacts market share.
• Labeling and Safety Data: Label updates addressing QT interval prolongation concerns influence usage.

What Is the Financial Trajectory of Alfuzosin Hydrochloride?

Revenue Trends

Significant revenue for alfuzosin is derived from generic sales, with a lack of new patented formulations. Revenue growth tracks with the expansion of generic markets, especially in emerging economies.

• Historical Revenue: Estimated at approximately $350 million in 2019, with flat to moderate growth until 2022.
• 2022 to 2028 Projections: Expected CAGR of 4-5%, reaching around $400-$450 million, contingent on regional adoption and formulary preferences.

Cost Structure and Profitability

• Manufacturing Costs: Marginally lower for generics due to streamlined production.
• Pricing Trends: Pressure from increasing generic competition reduces margins.
• Market Entry Barriers: Low, leading to high competition and price erosion.

Regulatory and Patent Factors

The absence of recent patents for alfuzosin formulations has resulted in robust generic competition, limiting revenue growth but enabling broader market access.

Investment and R&D Forecasts

Investments focus primarily on pharmacovigilance and formulation improvements to mitigate safety concerns. Limited R&D is directed at new indications, reflecting market maturity.

What Are the Key Market Drivers and Constraints?

Drivers

• Aging populations increasing BPH prevalence.
• Growing healthcare access in emerging markets.
• Increasing acceptance of oral alpha-blocker therapies.

Constraints

• Competition from newer alpha-1 blockers, such as tamsulosin.
• Safety concerns related to QT interval prolongation.
• Limited innovation due to patent expiration and market saturation.

Key Takeaways

• The global alfuzosin market remains sizable but mature, with steady growth driven by demographic trends.
• Generic competition exerts downward pressure on prices and margins.
• The primary revenue source is established markets in North America and Europe; Asia-Pacific shows expanding potential.
• Market dynamics are influenced by safety profiles, prescribing habits, and regulatory environments.
• Financial growth prospects are moderate, with a focus on maintaining market share amid competition.

FAQs

1. How does alfuzosin compare to other alpha-blockers for BPH?
Alfuzosin is uroselective, with fewer cardiovascular side effects compared to older non-selective alpha-blockers. However, tamsulosin often has higher market penetration due to its widespread prescriber familiarity.

2. What impact do safety concerns have on alfuzosin's market?
QT prolongation risks have led to updated labeling and selective prescribing, which can restrict usage. These safety considerations affect market share and market growth potential.

3. Are there upcoming formulation or patented innovations for alfuzosin?
No significant patents or innovative formulations are currently in development; focus remains on generic manufacturing and safety profile management.

4. How vital are emerging markets for alfuzosin’s future sales?
Highly significant; markets such as China, India, and Southeast Asia are experiencing rapid growth in BPH treatment adoption, offering expansion opportunities.

5. What regulatory hurdles could influence alfuzosin’s market?
Labeling updates related to safety, regional reformulations, and patent expirations are primary hurdles that can impact market access and sales.

References

1. Markets and Markets, “Benign Prostatic Hyperplasia (BPH) Drugs Market,” 2022.
2. IQVIA, “Global Pharma Market Reports,” 2022.
3. IMS Health, “Generic Drugs Market Analysis,” 2021.
4. US FDA, “Drug Safety Labels,” 2022.
5. European Medicines Agency, “BPH Treatments Overview,” 2022.