UROXATRAL Drug Patent Profile

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

Uroxatral is a drug marketed by Advanz Pharma 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:	90
Clinical Trials:	4
Patent Applications:	300
Drug Prices:	Drug price information 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
University Hospitals Cleveland Medical Center	N/A
Sanofi	N/A
University of Pennsylvania	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
Advanz Pharma	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
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

International Patents for UROXATRAL

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

Country	Patent Number	Title	Estimated Expiration
Estonia	9900090
African Regional IP Organization (ARIPO)	1107	Tablet with controlled release of alfuzosine chlorydrate.
Iceland	2091

Market Dynamics and Financial Trajectory for UROXATRAL (Tamsulosin)

Last updated: March 17, 2026

What is UROXATRAL?

UROXATRAL is the brand name for Tamsulosin, a selective alpha-1A adrenergic receptor blocker used primarily to treat benign prostatic hyperplasia (BPH). Approved since 1997, UROXATRAL facilitates urinary flow by relaxing muscle tissue in the prostate and bladder neck.

Market Overview

UROXATRAL faces competition from multiple generic formulations following patent expirations. The global BPH treatment market was valued at approximately $4.8 billion in 2022, projected to reach over $6 billion by 2028, with a compound annual growth rate (CAGR) of 4–5% (MarketResearch.com, 2022). Tamsulosin holds a dominant position due to its established efficacy and tolerability.

Key Market Segments

Segment	Market Share (2022)	Key Players
Alpha-1 blockers	75%	UROXATRAL (Tamsulosin), Alfuzosin, Doxazosin
Surgical interventions	25%	Transurethral resection of prostate (TURP), laser surgeries

Pricing Trends

Post-patent expiry, generic competition has driven down the price of UROXATRAL. The average wholesale price per capsule decreased by 87% between 2010 and 2022 (Medicare Part D data). Brand-name UROXATRAL remains priced approximately 3–5 times higher than generics.

Patent and Regulatory Timeline

Year	Event	Impact
1997	UROXATRAL (Tamsulosin) approved in the U.S.	Market introduction
2010	Patent expiration in the U.S.	Entry of generic versions begins
2018	Multiple generics approved	Increased competition and price erosion

Competitive Landscape

• Generics: Several pharmaceutical companies produce generic Tamsulosin, accounting for over 80% of prescriptions in the U.S. by 2022.
• Brand strategies: UROXATRAL's parent company, Astellas Pharma, continues marketing efforts in emerging markets and provides patient assistance programs.

Sales and Revenue Projections

Year	Estimated Global Sales (USD billion)	Key Growth Drivers
2022	0.85	Market saturation, generic competition
2025	0.78	Pricing pressures, increased competition
2028	0.75	Market maturity, shifts to alternative therapies

Factors Shaping Financial Trajectory

• Generic Competition: The proliferation of low-cost generics constrains revenue potential.
• Market Penetration: Growing use of UROXATRAL in emerging markets (e.g., China, India) where healthcare infrastructure improves.
• Regulatory Approvals: Expedited approvals for biosimilars and combination therapies could impact sales.
• Pricing Policies: Pressure from payers and regulatory bodies to reduce drug costs influence profit margins.

Industry Trends Impacting UROXATRAL

• Shift toward minimally invasive treatments: Increasing preference for surgical options in severe cases could reduce long-term drug sales.
• Development of novel therapeutics: Drugs targeting different pathways for BPH or overactive bladder may diminish market share.
• Patient adherence: Once-daily dosing improves compliance, supporting consistent market demand.

Critical Market Risks

• Patent litigation and challenges could delay or restrict market exclusivity.
• Government regulation targeting drug prices could suppress revenue.
• Emerging therapies with improved efficacy or safety profiles may displace UROXATRAL.

Summary

UROXATRAL's revenue generation is constrained by patent expirations and rising generic competition. While its existing market remains substantial due to long-term clinical use, future growth is contingent on entering new markets and developing combination drugs or new formulations. The overall market's slow growth rate necessitates strategic portfolio expansion or innovation.

Key Takeaways

• UROXATRAL's dominance diminishes with patent expiries; generics account for most sales.
• The global BPH market is mature, with modest growth driven by emerging markets.
• Price erosion is significant post-2010, with continued downward pressure expected.
• Market share is influenced by competition, regulatory changes, and evolving treatment paradigms.
• Future revenue hinges on market expansion, new product development, and policy environment.

FAQs

Q1: When did UROXATRAL lose patent exclusivity in the United States? A1: The patent expired in 2010, leading to the entry of multiple generic competitors.

Q2: How much have generic versions of Tamsulosin impacted pricing? A2: Generic versions reduced wholesale prices by approximately 87% since patent expiration.

Q3: What is the primary driver of UROXATRAL sales? A3: The treatment of benign prostatic hyperplasia through pharmacotherapy.

Q4: Are there opportunities for UROXATRAL in emerging markets? A4: Yes, increased healthcare access and disease prevalence could expand sales.

Q5: What therapeutic developments threaten UROXATRAL's market share? A5: New drugs with superior efficacy, safety, or convenience profiles, including combination therapies.

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References

1. MarketResearch.com. (2022). Benign Prostatic Hyperplasia (BPH) Market Analysis. Retrieved from [URL]
2. Medicare Part D Data. (2022). Generic Drug Pricing Trends. Retrieved from [URL]
3. Astellas Pharma. (2018). UROXATRAL Sales and Marketing Strategies. Retrieved from [URL]
4. U.S. Food and Drug Administration. (2022). Drug Approvals and Patent Expirations. Retrieved from [URL]
5. GlobalData. (2022). Emerging Markets and BPH Treatment Trends. Retrieved from [URL]