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. Forty-three 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:	2
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	46
Patent Applications:	1,795
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
Hackensack Meridian Health	N/A
St. Joseph's Healthcare Hamilton	Phase 4
NeoTract, Inc.	Phase 4

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	AB	RX	Yes	Yes

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
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997

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)
Spain	8201966
Japan	S6252742

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

FLOMAX Market Analysis and Financial Projection Experimental

The Market Dynamics and Financial Trajectory of Flomax (Tamsulosin)

Introduction

Flomax, known generically as tamsulosin, is a medication widely used to treat the symptoms of benign prostatic hyperplasia (BPH), a common condition in older men. This article delves into the market dynamics and financial trajectory of Flomax, highlighting its current status, growth drivers, and future prospects.

What is Flomax?

Flomax is an alpha-1 adrenergic antagonist that works by relaxing the muscles in the prostate and bladder neck, facilitating easier urination. It is primarily prescribed to alleviate urinary symptoms associated with BPH, such as difficulty starting urination, weak urine flow, and frequent urination[1].

Market Size and Growth

The market for BPH treatments, including Flomax, is experiencing significant growth. The global market for BPH medications is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next few years. This growth is driven by an aging population and increasing awareness about men's health issues[1].

By 2028, the market for drugs treating benign prostatic hypertrophy is expected to reach $5.45 billion, growing at a CAGR of 6.0%. This expansion is attributed to emerging markets, new drug developments, increasing awareness and education, and regulatory approvals[4].

Key Drivers of Growth

Increasing Prevalence of BPH

About 50% of men over the age of 50 experience BPH symptoms, creating a substantial demand for effective treatments like Flomax. The aging population globally is a significant driver of this market[1].

Growing Awareness of Men's Health

Campaigns promoting health screenings and education about prostate health have contributed to higher diagnosis rates and greater demand for treatments. This trend indicates a shift toward proactive health management among older men[1].

Innovations in Drug Formulations

Recent innovations in drug formulations have made Flomax more accessible and effective. Extended-release versions of Flomax allow for once-daily dosing, improving patient adherence and satisfaction. Combination therapies incorporating Flomax with other medications are also gaining traction, offering comprehensive treatment solutions for BPH patients[1].

Impact of Telehealth Services

The rise of telehealth services has made it easier for patients to access healthcare professionals, enabling timely diagnosis and treatment of BPH symptoms. This shift has led to increased prescriptions of Flomax as men are more likely to seek help for urinary issues when they can do so from the comfort of their homes[1].

Financial Performance and Market Impact

Historical Financials

The launch of generic Flomax by companies like Impax Laboratories has had a significant impact on the market. During its exclusive launch period, Impax Laboratories generated substantial revenue from generic Flomax sales, contributing $104.7 million to their net income in the first quarter of 2011. However, the entry of competing generic versions led to price erosion and a reduction in market share[2].

Current Market Value

The global market for drugs treating benign prostatic hypertrophy, which includes Flomax, is valued at $4.02 billion in 2023 and is expected to grow to $4.31 billion in 2024 at a CAGR of 7.1%. By 2028, the market is projected to reach $5.45 billion[4].

Market Trends and Strategies

Minimally Invasive Treatments

There is a growing trend toward minimally invasive treatments for BPH, which includes medications like Flomax. These treatments are preferred due to their lower risk and faster recovery times compared to surgical options[4].

Personalized Medicine and Combination Therapies

The market is seeing an increase in personalized medicine approaches and combination therapies that include Flomax. These strategies enhance the efficacy and convenience of treatment, driving market growth[4].

Telemedicine and Digital Health

The integration of telemedicine and digital health services is transforming the way patients access and manage their BPH treatments. This trend is expected to continue, further boosting the demand for Flomax and other BPH medications[4].

Major Players

The BPH treatment market includes several major players, such as Astellas Pharma, the original developer of Flomax. Other companies like Impax Laboratories and generic manufacturers also play significant roles in the market. These companies are investing heavily in research and development to innovate and expand their product offerings[2][4].

Investment Opportunities

The Flomax market presents numerous investment opportunities, particularly for companies innovating in the men's health space and focusing on sustainability. With the growing prevalence of BPH and an aging population, the potential for growth in this sector is promising. Investors are drawn to companies that are developing new drug formulations and leveraging technological advancements like telehealth[1].

Regulatory and Economic Factors

Impact of High Inflation and Global Events

The market for BPH treatments, including Flomax, can be affected by macroeconomic factors such as high inflation and global events like the Ukraine-Russia war. However, the essential nature of these medications tends to make the market more resilient to such external factors[4].

COVID-19 Impact

The COVID-19 pandemic has accelerated the adoption of telehealth services, which has positively impacted the market for Flomax and other BPH treatments. This shift is expected to be a long-term trend, supporting continued market growth[4].

Key Takeaways

• The Flomax market is driven by an increasing prevalence of BPH, growing awareness of men's health issues, and innovations in drug formulations.
• The market is expected to grow steadily, with a projected CAGR of 6.0% by 2028.
• Telehealth services and personalized medicine are key trends influencing the market.
• Major players are investing in research and development to innovate and expand their product offerings.
• The market presents significant investment opportunities, particularly in the areas of sustainability and technological advancements.

FAQs

What is the primary use of Flomax?

Flomax, or tamsulosin, is primarily used to treat the symptoms of benign prostatic hyperplasia (BPH), such as difficulty urinating and weak urine flow.

How does Flomax work?

Flomax works by relaxing the muscles in the prostate and bladder neck, which helps improve urine flow and reduce urinary symptoms associated with BPH.

What are the key drivers of the Flomax market?

The key drivers include the increasing prevalence of BPH, growing awareness of men's health issues, innovations in drug formulations, and the impact of telehealth services.

Who are the major players in the Flomax market?

Major players include Astellas Pharma, the original developer of Flomax, and other companies like Impax Laboratories that produce generic versions.

What is the projected growth of the Flomax market?

The market for BPH treatments, including Flomax, is expected to grow at a CAGR of approximately 6.0% by 2028, reaching $5.45 billion.

How has telehealth impacted the Flomax market?

Telehealth services have made it easier for patients to access healthcare professionals, leading to increased prescriptions of Flomax and other BPH medications.

Sources

1. Market Research Intellect: "The Rising Demand for Tamsulosin: A Deep Dive into the Urological Health Sector" - November 8, 2024.
2. Impax Laboratories: "Impax Laboratories Reports First Quarter 2011 Financial Results" - May 3, 2011.
3. Credence Research: "Benign Prostatic Hyperplasia Treatment Market Size & Forecast 2032".
4. The Business Research Company: "Drugs For Benign Prostatic hypertrophy Global Market Report 2024".