UROXATRAL Drug Patent Profile

When do Uroxatral patents expire, and when can generic versions of Uroxatral launch?

Uroxatral is a drug marketed by Concordia and is included in one NDA.

The generic ingredient in UROXATRAL 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 Uroxatral

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

Summary for UROXATRAL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	4
Patent Applications:	280
Drug Prices:	Drug price information for UROXATRAL
Drug Sales Revenues:	Drug sales revenues for UROXATRAL
What excipients (inactive ingredients) are in UROXATRAL?	UROXATRAL excipients list
DailyMed Link:	UROXATRAL at DailyMed

See drug prices for UROXATRAL

See drug sales revenues for UROXATRAL

Recent Clinical Trials for UROXATRAL

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

Sponsor	Phase
Sanofi	N/A
University Hospitals Cleveland Medical Center	N/A
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3

See all UROXATRAL clinical trials

Pharmacology for UROXATRAL

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

Paragraph IV (Patent) Challenges for UROXATRAL

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 UROXATRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Concordia	UROXATRAL	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021287-001	Jun 12, 2003	AB	RX	Yes	Yes

Expired US Patents for UROXATRAL

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	4,661,491*PED
Concordia	UROXATRAL	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021287-001	Jun 12, 2003	6,149,940*PED

International Patents for UROXATRAL

See the table below for patents covering UROXATRAL around the world.

Country	Patent Number	Title	Estimated Expiration
Ireland	861395
Poland	331862
Norway	326206

UROXATRAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for UROXATRAL (Alfuzosin HCl)

Introduction

UROXATRAL, the brand name for alfuzosin HCl, is a selective alpha1-adrenergic receptor antagonist used to treat the signs and symptoms of benign prostatic hyperplasia (BPH). Here, we will delve into the market dynamics and financial trajectory of this medication.

Mechanism of Action and Clinical Benefits

UROXATRAL works by relaxing the smooth muscle in the prostate, bladder neck, and prostatic urethra, thereby improving urine flow and reducing symptoms of BPH. This mechanism is crucial for its clinical efficacy, as evidenced by significant reductions in the International Prostate Symptom Score (IPSS) and improvements in peak urinary flow rates[1][4].

Market Position and Competition

In the market for BPH treatments, UROXATRAL competes with other alpha-blockers such as tamsulosin and doxazosin. However, its uroselective profile, which targets alpha1-adrenergic receptors in the lower urinary tract, minimizes systemic side effects like hypotension, giving it a competitive edge[1][4].

Economic Impact and Cost-Effectiveness

Studies have shown that treating patients with UROXATRAL during hospitalization for acute urinary retention (AUR) and in the first 6 months after a successful trial without catheter (TWOC) is cost-effective. It reduces the need for emergency surgery and lowers treatment costs. For instance, a study in the UK's National Health Service (NHS) found that alfuzosin treatment generated significant cost savings compared to placebo and immediate prostatectomy[2].

Patient Outcomes and Quality of Life

UROXATRAL not only improves urinary symptoms but also has a positive impact on sexual function. Long-term studies have demonstrated sustained benefits in reducing LUTS and improving sexual function, including stiffness of erection, volume of ejaculate, and pain upon ejaculation[4].

Safety and Tolerability

The drug is generally well-tolerated, with common side effects including dizziness, upper respiratory tract infections, headache, and fatigue. It is contraindicated in patients with moderate or severe hepatic insufficiency and should be used cautiously in those with severe renal insufficiency or a known history of QT prolongation[1][4][5].

Market Trends and Growth

The market for BPH treatments is driven by the increasing prevalence of the condition, particularly among aging populations. UROXATRAL, with its established efficacy and safety profile, continues to be a preferred treatment option. The drug's long-term benefits and cost-effectiveness contribute to its stable market presence and growth potential.

Financial Performance

The financial performance of UROXATRAL is influenced by several factors, including prescription rates, pricing strategies, and competition. While specific financial data for UROXATRAL is not publicly disclosed, the overall market for BPH treatments is substantial. For example, the potential U.S. market for therapies in advanced prostate conditions, which includes BPH treatments, is estimated to be over $5 billion[3].

Regulatory Environment

UROXATRAL has been approved by regulatory bodies such as the FDA, and its use is guided by strict prescribing information. The drug should not be administered with potent CYP3A4 inhibitors, and caution is advised in patients with certain medical conditions[1][4].

Future Outlook

Given the aging population and the increasing incidence of BPH, the demand for effective treatments like UROXATRAL is expected to remain strong. Pharmaceutical companies, such as those mentioned in the annual reports, continue to invest in urology products, including new formulations and combinations that could further enhance the market dynamics of BPH treatments[3].

Key Takeaways

• Clinical Efficacy: UROXATRAL is effective in reducing LUTS and improving urinary flow and sexual function.
• Cost-Effectiveness: The drug offers significant cost savings by reducing the need for emergency surgery and lowering treatment costs.
• Market Position: It competes favorably with other alpha-blockers due to its uroselective profile.
• Safety and Tolerability: Generally well-tolerated, but with specific contraindications and precautions.
• Financial Performance: Part of a substantial market for BPH treatments, with growth potential driven by demographic trends.

FAQs

What is UROXATRAL used for?

UROXATRAL is used to treat the signs and symptoms of benign prostatic hyperplasia (BPH), including lower urinary tract symptoms.

How does UROXATRAL work?

UROXATRAL works by relaxing the smooth muscle in the prostate, bladder neck, and prostatic urethra, thereby improving urine flow and reducing symptoms of BPH.

What are the common side effects of UROXATRAL?

Common side effects include dizziness, upper respiratory tract infections, headache, and fatigue.

Is UROXATRAL cost-effective?

Yes, studies have shown that UROXATRAL is cost-effective by reducing the need for emergency surgery and lowering treatment costs.

Can UROXATRAL be used in patients with hepatic or renal insufficiency?

UROXATRAL is contraindicated in patients with moderate or severe hepatic insufficiency and should be used cautiously in those with severe renal insufficiency.

Sources

1. UROXATRAL® (alfuzosin HCl extended-release tablets) Label. FDA.
2. The economic impact of using alfuzosin 10 mg once daily .... PubMed.
3. 2018 ANNUAL REPORT - Annual Reports. Veru Inc.
4. UROXATRAL® (alfuzosin HCl) STUDY SHOWS IMPROVEMENT UP .... Sanofi US.
5. Alfuzosin (oral route) - Mayo Clinic. Mayo Clinic.