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Last Updated: December 22, 2024

ALFUZOSIN HYDROCHLORIDE Drug Patent Profile


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Which patents cover Alfuzosin Hydrochloride, and when can generic versions of Alfuzosin Hydrochloride launch?

Alfuzosin Hydrochloride is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Invagen Pharms, Norvium Bioscience, Sun Pharm, Torrent Pharms, Unichem, and Wockhardt. and is included in nine NDAs.

The generic ingredient in ALFUZOSIN HYDROCHLORIDE is alfuzosin hydrochloride. There are nineteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the alfuzosin hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Alfuzosin Hydrochloride

A generic version of ALFUZOSIN HYDROCHLORIDE was approved as alfuzosin hydrochloride by APOTEX INC on July 18th, 2011.

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Drug patent expirations by year for ALFUZOSIN HYDROCHLORIDE
Recent Clinical Trials for ALFUZOSIN HYDROCHLORIDE

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SponsorPhase
Beth Israel Deaconess Medical CenterN/A
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)N/A
Gundersen Lutheran Medical FoundationPhase 4

See all ALFUZOSIN HYDROCHLORIDE clinical trials

Pharmacology for ALFUZOSIN HYDROCHLORIDE
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
Apotex Inc ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 079013-001 Jul 18, 2011 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Torrent Pharms ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 079054-001 Jul 18, 2011 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Invagen Pharms ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 090284-001 Jan 17, 2012 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Unichem ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 203192-001 Jan 28, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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]

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