TAMSULOSIN HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for tamsulosin hydrochloride and what is the scope of freedom to operate?

Tamsulosin hydrochloride is the generic ingredient in two branded drugs marketed by Sanofi, Alkem Labs Ltd, Ascent Pharms Inc, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Impax Labs, Macleods Pharms Ltd, Norvium Bioscience, Sandoz, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Wockhardt, and Zydus Pharms Usa Inc, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for tamsulosin hydrochloride. Forty-three suppliers are listed for this compound.

Summary for TAMSULOSIN HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	15
NDAs:	15
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	201
Patent Applications:	2,963
What excipients (inactive ingredients) are in TAMSULOSIN HYDROCHLORIDE?	TAMSULOSIN HYDROCHLORIDE excipients list
DailyMed Link:	TAMSULOSIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for TAMSULOSIN HYDROCHLORIDE

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

Sponsor	Phase
Hackensack Meridian Health	N/A
NorthShore University HealthSystem	Phase 3
Benha University	N/A

See all TAMSULOSIN HYDROCHLORIDE clinical trials

Pharmacology for TAMSULOSIN HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for TAMSULOSIN HYDROCHLORIDE

G04CA	Alpha-adrenoreceptor antagonists
G04C	DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for TAMSULOSIN HYDROCHLORIDE

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 TAMSULOSIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	202010-001	Jan 4, 2013		DISCN	No	No
Teva Pharms	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	077630-001	Apr 27, 2010	AB	RX	No	No
Wockhardt	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	078938-001	Apr 27, 2010	AB	RX	No	No
Alkem Labs Ltd	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	207405-001	Aug 11, 2017	AB	RX	No	No
Ascent Pharms Inc	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	214730-001	May 4, 2022		DISCN	No	No
Synthon Pharms	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	078801-001	Apr 27, 2010	AB	RX	No	No
Sandoz	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	078015-001	Apr 27, 2010	AB	RX	No	No

Expired US Patents for TAMSULOSIN HYDROCHLORIDE

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	4,731,478
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997	4,772,475

TAMSULOSIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tamsulosin Hydrochloride

Introduction to Tamsulosin Hydrochloride

Tamsulosin hydrochloride is a medication primarily used to treat lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH), a common condition in older men. The drug works by relaxing the muscles in the prostate and the opening of the bladder, thereby improving urine flow and reducing symptoms[3].

Market Size and Growth

The global tamsulosin market has been experiencing significant growth and is projected to continue this trend. By 2032, the market is expected to reach a value of USD 1.8 billion, driven by a compound annual growth rate (CAGR) of 6.3%[1].

Driving Factors

Several factors are driving the growth of the tamsulosin market:

Increased Incidence of BPH

The rising incidence of BPH among the aging male population is a major driver. As the global population ages, the demand for treatments like tamsulosin is expected to increase[1].

Adoption of Generic Versions

The increased adoption of generic versions of tamsulosin has expanded the market reach. Generic formulations, such as those developed by Krka d.d., offer cost-effective alternatives to the original branded products, making the treatment more accessible to a broader patient base[5].

Market Segmentation

The tamsulosin market is segmented based on type and application:

Type

The market includes capsules and tablets, with prolonged-release formulations being particularly popular due to their convenience and efficacy[1][5].

Application

The primary applications are in hospitals and drug stores. The hospital segment accounted for a significant share of the global tamsulosin market in 2023 and is expected to experience significant growth in the near future[4].

Regional Analysis

The tamsulosin market is analyzed across several major regions, including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region has its own growth trends and market dynamics:

North America and Europe

These regions have well-established healthcare systems and a high prevalence of BPH, contributing to a substantial market share.

Asia Pacific

This region is expected to show significant growth due to the large and aging population, along with increasing healthcare expenditure[4].

Competitive Landscape

The tamsulosin market is competitive, with several key players focusing on strategy building and product portfolio expansion. Companies like CSL Biotherapies Limited and Krka d.d. are prominent in the market, offering both branded and generic versions of tamsulosin[2][5].

Economic Analysis

Economic evaluations of tamsulosin have shown mixed results:

Cost-Effectiveness

In some analyses, such as the one conducted by the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia, tamsulosin was found to have an unacceptably high and uncertain incremental cost-utility ratio. This led to the rejection of its listing on the PBS due to concerns over cost-effectiveness[2].

Financial Implications

Despite these challenges, the financial implications of tamsulosin use are significant. For instance, the estimated financial cost to the PBS in Australia was projected to be up to $10-30 million per year[2].

Clinical and Safety Profile

Tamsulosin is generally well-tolerated but has some notable side effects:

Efficacy

Tamsulosin has been shown to be effective in reducing LUTS symptoms, with comparative effectiveness similar to other treatments like prazosin. However, its superiority in terms of safety is a subject of ongoing evaluation[2].

Safety Concerns

Common side effects include ejaculation problems, priapism, and increased risks during cataract surgery. These safety concerns are part of the risk management plan submitted by the Marketing Authorisation Holder (MAH)[5].

Regulatory Approvals and Bioequivalence

Generic versions of tamsulosin, such as Tamsulosine HCl Krka, have been approved based on bioequivalence studies. These studies ensure that the generic products have a similar dissolution profile and gelling behavior to the innovator product, Omnic Ocas 0.4[5].

Environmental and Non-Clinical Aspects

The environmental risk assessment for tamsulosin is not deemed necessary since it is intended for generic substitution and does not lead to increased environmental exposure. Non-clinical aspects, including ecotoxicity and pharmacokinetic parameters, have been evaluated to ensure compliance with regulatory standards[5].

Future Prospects and Trends

The tamsulosin market is expected to continue growing, driven by demographic changes and the increasing need for effective treatments for BPH. Here are some key trends:

Technological Advancements

Advancements in drug delivery systems, such as prolonged-release formulations, are expected to enhance patient compliance and treatment efficacy.

Market Expansion

The market is likely to expand into new regions, particularly in Asia Pacific, where there is a large and growing population with increasing healthcare needs.

Generic Competition

The rise of generic versions will continue to play a significant role in market dynamics, offering cost-effective alternatives and increasing market accessibility.

Key Takeaways

• The global tamsulosin market is projected to reach USD 1.8 billion by 2032, with a CAGR of 6.3%.
• Increased incidence of BPH and adoption of generic versions are key drivers.
• The market is segmented into capsules and tablets, with applications in hospitals and drug stores.
• Regional growth varies, with Asia Pacific expected to show significant expansion.
• Economic evaluations highlight the need for careful cost-effectiveness analysis.
• Tamsulosin is generally well-tolerated but has specific safety concerns.
• Regulatory approvals and bioequivalence studies ensure the quality of generic products.

Frequently Asked Questions (FAQs)

1. What is the expected market size of tamsulosin by 2032?

The global tamsulosin market is expected to reach USD 1.8 billion by 2032[1].

2. What is the CAGR of the tamsulosin market?

The tamsulosin market is expected to exhibit a CAGR of 6.3% by 2032[1].

3. What are the primary drivers of the tamsulosin market?

The primary drivers include the increased incidence of BPH and the increased adoption of generic versions of tamsulosin[1].

4. What are the common side effects of tamsulosin?

Common side effects include ejaculation problems, priapism, and increased risks during cataract surgery[2][5].

5. How is the tamsulosin market segmented?

The market is segmented based on type (capsules and tablets) and application (hospitals and drug stores)[1][4].

Sources:

1. Business Research Insights - Tamsulosin Market Size, Trends & Growth Analysis by 2032
2. PBS Australia - Tamsulosin hydrochloride, prolonged release tablet, 400 microgram
3. Mayo Clinic - Tamsulosin (oral route)
4. Cognitive Market Research - Tamsulosin Market Report 2024 (Global Edition)
5. Geneesmiddeleninformatiebank.nl - Public Assessment Report Scientific discussion Tamsulosine HCl Krka 0.4 mg prolonged-release tablets