FLOMAX Drug Patent Profile

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

Flomax is a drug marketed by Sanofi and is included in one NDA.

The generic ingredient in FLOMAX is tamsulosin hydrochloride. There are thirty-three drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the tamsulosin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Flomax

A generic version of FLOMAX was approved as tamsulosin hydrochloride by IMPAX LABS on March 2^nd, 2010.

Summary for FLOMAX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	47
Patent Applications:	2,381
Drug Prices:	Drug price information for FLOMAX
Drug Sales Revenues:	Drug sales revenues for FLOMAX
What excipients (inactive ingredients) are in FLOMAX?	FLOMAX excipients list
DailyMed Link:	FLOMAX at DailyMed

See drug prices for FLOMAX

See drug sales revenues for FLOMAX

Recent Clinical Trials for FLOMAX

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

Sponsor	Phase
Emory University	PHASE3
ABRAHAM J & PHYLLIS KATZ FOUNDATION	PHASE3
Hackensack Meridian Health	N/A

See all FLOMAX clinical trials

Pharmacology for FLOMAX

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

Paragraph IV (Patent) Challenges for FLOMAX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FLOMAX	Capsules	tamsulosin hydrochloride	0.4 mg	020579	1	2004-12-20

US Patents and Regulatory Information for FLOMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997		DISCN	Yes	No

Expired US Patents for FLOMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997	4,703,063*PED
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997	4,868,216
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997	4,772,475
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997	4,731,478

International Patents for FLOMAX

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

Country	Patent Number	Title	Estimated Expiration
Canada	1177849	METHODE D'OBTENTION DE PHENETHYLAMINES SULFAMYLEES (PROCESS OF PRODUCING SULFAMOYL-SUBSTITUTED PHENETHYLAMINE DERIVATIVES)
Argentina	230433	PROCEDIMIENTO PARA PRODUCIR DERIVADOS FENETILAMINICOS SULFAMOIL SUSTITUIDOS
U.S.S.R.	1248533	"CПOCOБ ПOЛУЧEHИЯ CУЛЬФAMOИЛЗAMEЩEHHЫX ПPOИЗBOДHЫX ФEHЭTИЛAMИHA ИЛИ EГO COЛЯHOKИCЛOЙ COЛИ" (METHOD OF PRODUCING SULFAMOYL-SUBSTITUTED DERIVATIVES OF PHENETHYLAMINE OR HYDROCHLORIDE THEREOF)
European Patent Office	0034432	SULFAMOYL-SUBSTITUTED PHENETHYLAMINE DERIVATIVES, THEIR PREPARATION, AND PHARMACEUTICAL COMPOSITIONS, CONTAINING THEM
U.S.S.R.	1181540	"CПOCOБ ПOЛУЧEHИЯ CУЛЬФAMOИЛЗAMEЩEHHOГO ПPOИЗBOДHOГO ФEHЭTИЛAMИHA И EГO KИCЛOTHOЙ COЛИ" (METHOD OF PRODUCING SULFAMOYL-SUBSTITUTED DERIVATIVES OF PHENETHYLAMINE AND ITS ACID SALT)
Austria	7223
Greece	73827

Supplementary Protection Certificates for FLOMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0034432	96C0048	Belgium		PRODUCT NAME: SAQUINAVIR; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
0034432	SPC/GB96/017: EXPIRE	United Kingdom		SPC/GB96/017: EXPIRES: 20060201

Market Dynamics and Financial Trajectory for FloMax (Tamsulosin)

Last updated: July 29, 2025

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Introduction

FloMax, the flagship brand for tamsulosin, a selective alpha-1 adrenergic receptor antagonist, plays a significant role in managing benign prostatic hyperplasia (BPH). As BPH prevalence increases globally, particularly among aging male populations, FloMax’s market dynamics and financial trajectory have become focal points for industry stakeholders. This analysis delineates current market conditions, competitive landscape, regulatory developments, and revenue forecasts shaping FloMax’s future.

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Global Market Overview

Prevalence of BPH and Treatment Demand

Benign prostatic hyperplasia affects approximately 50% of men aged 51–60 and up to 90% of men over 80, according to the American Urological Association.[1] The rising aging demographic, coupled with increased awareness and diagnosis rates, fuels demand for pharmacological interventions such as FloMax.

Market Size and Growth Trends

The global BPH therapeutics market was valued at an estimated USD 4.2 billion in 2022, with a compound annual growth rate (CAGR) forecasted at 5.3% from 2023 to 2030.[2] Tamsulosin accounts for a significant share, especially in North America and Europe, where it remains a first-line oral therapy.

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Product Profile and Market Position

Mechanism and Advantages

FloMax’s selective alpha-1A adrenergic blockade leads to relaxation of prostatic smooth muscle, improving urine flow with minimal cardiovascular side effects, contrasting with non-selective agents.[3] Its once-daily dosing and established safety profile underpin its popularity.

Market Share and Competition

Despite the presence of generics, FloMax retains a dominant position through brand loyalty, physician prescribing habits, and extensive clinical data. However, generic tamsulosin formulations have eroded some market share, predicted to expand as patent exclusivity wanes (patent expiry typically around 2024-2025 for FloMax).[4]

Key competitors include:

• Silodosin (Uroselective alpha-1A blocker)
• Doxazosin (non-selective alpha-1 blocker)
• Alfuzosin (cardiovascular risk profile)

These alternatives, often priced lower, challenge FloMax’s premium positioning.

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Regulatory and Patent Landscape

Patent Expirations and Generic Entry

FloMax’s patent protection prevents generics from entering the market, securing higher margins until around 2024–2025. The imminent expiration presents a pivotal point, likely precipitating a sharp decline in sales unless mitigated by new formulations or indications.

Regulatory Developments

Regulatory agencies, including the FDA, continue to approve biosimilars and generics, pressuring branded products. Recent guideline updates favor cost-effective therapies, influencing prescribing patterns.[5]

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Financial Trajectory

Revenue Trends

Leading manufacturers report steady revenues for FloMax, with global sales approximating USD 1.1 billion in 2022.[6] However, sales growth is plateauing due to market saturation, patent expiration, and competition.

Impact of Patent Expiry

Post-patent expiry, generic market penetration is projected to cause up to 30-50% revenue erosion within 2-3 years. Companies counteract this through:

• Expanding indications (e.g., early-stage BPH)
• Developing combination therapies
• Implementing pricing strategies

Emerging Market Opportunities

Growth prospects in emerging economies (China, India, Brazil) remain promising, driven by increasing healthcare access and rising BPH awareness. These markets, however, often favor generic formulations, affecting Branded FloMax’s revenues.

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Future Outlook and Strategic Considerations

Product Life Cycle and Innovation

Innovative formulations—such as sustained-release capsules—and combination therapies (e.g., tamsulosin with 5-alpha-reductase inhibitors) could extend FloMax’s profitability past patent expiry.

Market Penetration of Biosimilars and Generics

Regulatory approval of biosimilars and generics will intensify price competition, necessitating strategic investments in marketing, clinical research, and lifecycle management.

Potential for New Indications

Research exploring FloMax’s role in other urological or cardiovascular conditions could diversify revenue streams, but current evidence remains limited.

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Conclusion

FloMax's market dynamics are characterized by a mature, competitive landscape heavily influenced by patent expiration, generic entry, and regional market differences. While the drug commands a strong global footprint due to its efficacy and safety, its financial trajectory faces headwinds from patent expiry, prompting companies to explore innovation, diversification, and market expansion to sustain revenue.

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Key Takeaways

• The global BPH market continues to grow, sustaining demand for drugs like FloMax.
• Patent expiration (~2024-2025) is poised to cause significant sales decline due to generic competition.
• Competition from other selective and non-selective alpha-1 blockers intensifies pricing pressures.
• Strategic diversification into new formulations, combination therapies, and emerging markets can mitigate revenue erosion.
• Regulatory landscape shifts toward cost-effective therapies emphasizing the importance of lifecycle management.

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FAQs

1. When does FloMax’s patent protection expire, and how will this affect sales?
   Patent protection is expected to expire around 2024–2025, likely leading to increased generic competition and a substantial decline in branded sales.

2. How does FloMax compare to its competitors in treating BPH?
   FloMax’s selective alpha-1A blockade offers good efficacy with fewer cardiovascular side effects, maintaining a strong position despite competition from other agents like silodosin and doxazosin.

3. What strategies are manufacturers employing to sustain FloMax’s profitability post-patent expiry?
   Strategies include developing new formulations, expanding indications, marketing combination therapies, and targeting emerging markets.

4. Are biosimilars or generics impacting FloMax’s market share?
   Yes, as patents expire, biosimilars and generics will provide lower-cost options, eroding FloMax’s market share, especially in price-sensitive regions.

5. What is the outlook for FloMax in emerging markets?
   Growth potential remains high due to increasing healthcare access and BPH awareness, though reliance on cost-effective generics may limit branded sales expansion.

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Sources

[1] American Urological Association. (2021). Guidelines on the management of BPH.
[2] MarketWatch. (2023). Global BPH therapeutics market size & forecast.
[3] Roehrborn, C. G. (2006). Alpha-adrenoceptor blockers for BPH.
[4] FDA Patent and Exclusivity Data. (2023).
[5] World Health Organization. (2022). Guidelines for treatment of BPH.
[6] IQVIA. (2022). Pharmaceutical sales data for tamsulosin.