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, Norvium Bioscience, Sun Pharm, Torrent Pharms, Unichem, Wockhardt, and Concordia, 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:	104
Clinical Trials:	45
Patent Applications:	427
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	N/A
Beth Israel Deaconess Medical Center	N/A
Gundersen Lutheran Medical Foundation	Phase 4

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
Invagen Pharms	ALFUZOSIN HYDROCHLORIDE	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090284-001	Jan 17, 2012	AB	RX	No	No
Norvium Bioscience	ALFUZOSIN HYDROCHLORIDE	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079014-001	Jul 18, 2011		DISCN	No	No
Apotex Inc	ALFUZOSIN HYDROCHLORIDE	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079013-001	Jul 18, 2011	AB	RX	No	No
Torrent Pharms	ALFUZOSIN HYDROCHLORIDE	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079054-001	Jul 18, 2011		DISCN	No	No
Wockhardt	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
Concordia	UROXATRAL	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021287-001	Jun 12, 2003
Concordia	UROXATRAL	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021287-001	Jun 12, 2003

ALFUZOSIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Alfuzosin Hydrochloride

Introduction

Alfuzosin hydrochloride, marketed under brand names such as Uroxatral and Xatral, is an alpha-1 adrenergic blocker used primarily for the symptomatic treatment of benign prostatic hyperplasia (BPH). Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global alfuzosin market has been experiencing steady growth. As of 2023, the market size was valued at USD 0.5 billion and is projected to reach USD 0.68 billion by 2031, growing at a compound annual growth rate (CAGR) of 4% from 2024 to 2031[4].

Demand Drivers

Several factors drive the demand for alfuzosin hydrochloride:

Prevalence of BPH

BPH is a common condition among older men, with a prevalence of 50%-60% in men in their 60s and increasing to 80%-90% in those over 70. This high prevalence ensures a consistent demand for treatments like alfuzosin hydrochloride[2].

Efficacy and Safety Profile

Alfuzosin has demonstrated sustained efficacy in reducing lower urinary tract symptoms (LUTS) and improving sexual function in men with BPH. Studies have shown that men treated with alfuzosin experience significant improvements in urinary symptoms and sexual function over long-term use[3].

Competitive Landscape

The market for BPH treatments is competitive, but alfuzosin hydrochloride maintains a strong position due to its uroselective properties, which minimize systemic side effects compared to other alpha-blockers. This selectivity contributes to its market appeal and patient preference[2].

Financial Performance

The financial performance of alfuzosin hydrochloride is influenced by several factors:

Revenue Streams

The primary revenue stream for alfuzosin hydrochloride comes from prescription sales. The drug is widely prescribed by urologists and primary care physicians for the management of BPH symptoms.

Pricing and Reimbursement

The pricing of alfuzosin hydrochloride can vary by region and is influenced by local healthcare policies and reimbursement schemes. In many countries, the drug is covered by health insurance plans, which helps maintain a stable revenue stream.

Generic Competition

The introduction of generic versions of alfuzosin hydrochloride has impacted the market dynamics. Generic competition can reduce the market share of branded products, but the established brand reputation and patient loyalty to Uroxatral and Xatral help mitigate this impact to some extent[2].

Key Market Trends

Increasing Geriatric Population

The global population is aging, which increases the incidence of BPH and subsequently drives the demand for alfuzosin hydrochloride.

Advances in Treatment Options

Continuous research and development in the field of urology may lead to new treatment options, but alfuzosin hydrochloride's established efficacy and safety profile ensure it remains a preferred choice for many patients.

Regulatory Environment

Regulatory approvals and compliance with FDA guidelines are crucial for the continued market presence of alfuzosin hydrochloride. The drug has been approved and is compliant with all necessary regulatory requirements[1][5].

Adverse Events and Safety Considerations

While alfuzosin hydrochloride is generally well-tolerated, it does come with some safety considerations that can impact its financial trajectory:

Postural Hypotension and Syncope

The risk of postural hypotension and syncope, particularly in patients with symptomatic hypotension or those taking antihypertensive medications, requires careful patient selection and monitoring. This can affect prescribing rates and patient compliance[5].

Hepatic and Renal Impairment

Caution is advised in patients with mild hepatic impairment and severe renal impairment, which may limit the drug's use in certain patient populations[5].

Market Projections and Future Outlook

Long-Term Efficacy

Studies have shown that alfuzosin hydrochloride provides sustained benefits over two years, which reinforces its long-term market potential[3].

Expanding Indications

Although alfuzosin hydrochloride is primarily used for BPH, research into other potential indications could expand its market reach.

Global Expansion

The drug's market is expected to grow in emerging economies where healthcare infrastructure is improving and the aging population is increasing.

Key Takeaways

• Market Growth: The alfuzosin hydrochloride market is projected to grow at a CAGR of 4% from 2024 to 2031.
• Demand Drivers: High prevalence of BPH, efficacy, and safety profile drive demand.
• Financial Performance: Revenue is primarily from prescription sales, influenced by pricing, reimbursement, and generic competition.
• Market Trends: Increasing geriatric population, advances in treatment options, and regulatory environment are key trends.
• Safety Considerations: Postural hypotension, syncope, and impairment in hepatic and renal functions are important safety considerations.

FAQs

What is the primary indication for alfuzosin hydrochloride?

Alfuzosin hydrochloride is primarily indicated for the symptomatic treatment of benign prostatic hyperplasia (BPH)[2].

How does alfuzosin hydrochloride work?

Alfuzosin hydrochloride works by selectively inhibiting alpha-1 adrenergic receptors in the lower urinary tract, leading to the relaxation of smooth muscle in the prostate and bladder neck, thereby improving urine flow and reducing BPH symptoms[2].

What are the common side effects of alfuzosin hydrochloride?

Common side effects include dizziness, upper respiratory tract infection, headache, and fatigue[5].

Can alfuzosin hydrochloride be used in patients with hepatic or renal impairment?

Alfuzosin hydrochloride should be used with caution in patients with mild hepatic impairment and should not be used in patients with moderate or severe hepatic insufficiency. It should also be used with caution in patients with severe renal insufficiency[5].

Is alfuzosin hydrochloride available in generic form?

Yes, alfuzosin hydrochloride is available in generic form, which can impact the market share of branded products[2].

Sources

1. FDA: Alfuzosin Clinical BPCA - FDA[1]
2. DrugBank: Alfuzosin: Uses, Interactions, Mechanism of Action | DrugBank Online[2]
3. Sanofi: UROXATRAL® (alfuzosin HCl) STUDY SHOWS IMPROVEMENT UP ...[3]
4. Market Research Intellect: Alfuzosin Market Size and Projections - Market Research Intellect[4]
5. Drugs.com: Alfuzosin Tablets: Package Insert / Prescribing Info - Drugs.com[5]