Dutasteride; tamsulosin hydrochloride - Generic Drug Details

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

Dutasteride; tamsulosin hydrochloride is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Aurobindo Pharma, Endo Operations, Zydus Pharms, and Waylis Therap, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for dutasteride; tamsulosin hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	6
Clinical Trials:	21
DailyMed Link:	dutasteride; tamsulosin hydrochloride at DailyMed

Recent Clinical Trials for dutasteride; tamsulosin hydrochloride

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

Sponsor	Phase
Beth Israel Deaconess Medical Center	N/A
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	N/A
Ministry of Health, France	Phase 3

See all dutasteride; tamsulosin hydrochloride clinical trials

Pharmacology for dutasteride; tamsulosin hydrochloride

Drug Class	5-alpha Reductase Inhibitor alpha-Adrenergic Blocker
Mechanism of Action	5-alpha Reductase Inhibitors Adrenergic alpha-Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for dutasteride; tamsulosin hydrochloride

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

G04CB	Testosterone-5-alpha reductase inhibitors
G04C	DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JALYN	Capsules	dutasteride; tamsulosin hydrochloride	0.5 mg/0.4 mg	022460	1	2010-10-26

US Patents and Regulatory Information for dutasteride; tamsulosin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	207769-001	May 24, 2018	AB	RX	No	No
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010	AB	RX	Yes	Yes
Actavis Labs Fl Inc	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	202975-001	Nov 20, 2015		DISCN	No	No
Endo Operations	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	202509-001	Feb 26, 2014	AB	RX	No	No
Aurobindo Pharma	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	213300-001	Jul 18, 2024	AB	RX	No	No

Expired US Patents for dutasteride; tamsulosin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010

Dutasteride; tamsulosin hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dutasteride and Tamsulosin Hydrochloride

Introduction

Dutasteride and tamsulosin hydrochloride, commonly used in the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate, are pivotal drugs in the urological pharmaceutical market. This article delves into the market dynamics and financial trajectory of these medications, highlighting key trends, drivers, and financial projections.

Market Size and Growth

The global market for tamsulosin, a key component of the combination therapy, is expected to exhibit significant growth. By 2032, the tamsulosin market is projected to reach USD 1.8 billion, with a Compound Annual Growth Rate (CAGR) of 6.3%[1].

Driving Factors

Several factors are driving the growth of the dutasteride and tamsulosin hydrochloride market:

Increased Incidence of BPH

The rising incidence of benign prostatic hyperplasia is a major driver. As the global population ages, the prevalence of BPH is expected to increase, thereby boosting the demand for these medications[1].

Increased Adoption of Generic Versions

The expiration of patents for branded versions of these drugs has led to an increase in the adoption of generic versions. This shift is driven by cost-effectiveness and the availability of AB-rated generic equivalents, such as those approved for Aurobindo Pharma Limited[4].

Market Segmentation

The market for dutasteride and tamsulosin hydrochloride can be segmented in several ways:

By Type

The market includes capsules and tablets as the primary forms of administration. The combination capsule of dutasteride and tamsulosin hydrochloride, such as Jalyn, is a significant segment[1][4].

By Application

The primary applications are in hospitals and drug stores. The ease of administration and the availability of these medications in various healthcare settings contribute to their widespread use[1].

Clinical Efficacy and Safety

Clinical trials have demonstrated the efficacy and safety of the combination therapy. The co-administration of dutasteride and tamsulosin has shown statistically significant improvements in symptoms, as measured by the International Prostate Symptom Score (IPSS) and maximum urinary flow rate (Qmax), compared to monotherapy[2].

Risk-Benefit Profile

The overall risk-benefit profile of the combination therapy is favorable. While there have been observations of a numerical imbalance in the incidence of cardiac failure, this has not precluded the approval of the combination capsule. The safety findings have been satisfactory, and the benefit of the combination therapy over monotherapy has been well-established[2].

Regulatory Landscape

The regulatory approval process for dutasteride and tamsulosin hydrochloride combination capsules has been complex due to patent and exclusivity issues. The FDA approved the combination capsule after the expiration of the exclusivity period for tamsulosin, allowing for the entry of generic versions into the market[2][4].

Financial Trajectory

Market Size and Revenue

The estimated market size for dutasteride and tamsulosin hydrochloride capsules is around $9 million for the twelve months ending May 2024, according to IQVIA data. This figure is expected to grow as the generic market expands and more patients are treated with these medications[4].

Generic Market Impact

The generic sector continues to thrive, driven by cost-effectiveness and increased adoption. Companies like Aurobindo Pharma Limited are benefiting from the approval of their generic versions, which are AB-rated equivalents to branded drugs like Jalyn[3][4].

Consolidation and Collaboration

The pharmaceutical industry, particularly the generic sector, is experiencing consolidation and collaboration. Companies are acquiring other firms and forming joint ventures to enhance their capabilities and market presence. This trend is expected to continue, influencing the financial trajectory of drugs like dutasteride and tamsulosin hydrochloride[3].

Competitive Landscape

The market for dutasteride and tamsulosin hydrochloride is competitive, with multiple players involved:

Branded vs. Generic

The branded market, initially dominated by drugs like Jalyn, is now facing competition from generic versions. Companies like Aurobindo Pharma Limited and others are gaining market share with their AB-rated generic equivalents[4].

Key Players

Aurobindo Pharma Limited, Teva, and other generic pharmaceutical companies are key players in this market. Their ability to produce cost-effective generic versions is driving market growth and changing the competitive dynamics[3][4].

Challenges and Opportunities

Cost Pressures

Despite the growth, the generic sector faces cost pressures due to government spending cuts and reduced reimbursement rates. This squeeze on margins can impact the financial performance of companies involved in this market[3].

Expanding Market Reach

The increasing adoption of generic versions and the growing incidence of BPH present significant opportunities for market expansion. Companies that can navigate the regulatory landscape and maintain cost-effectiveness are likely to benefit from these trends[1][3].

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 the adoption of generic versions are key drivers.
• The combination therapy of dutasteride and tamsulosin hydrochloride has a favorable risk-benefit profile.
• Regulatory approvals and the expiration of exclusivity periods have opened the market to generic versions.
• The financial trajectory is influenced by the generic market's growth, consolidation, and cost pressures.

FAQs

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

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

What is the CAGR of the tamsulosin market?

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

What are the primary drivers of the dutasteride and tamsulosin hydrochloride market?

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

What is the recommended dosage of Jalyn (dutasteride and tamsulosin hydrochloride) capsules?

The recommended dosage is 1 capsule (0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride) taken once daily approximately 30 minutes after the same meal each day[5].

Which companies have received FDA approval for generic versions of dutasteride and tamsulosin hydrochloride capsules?

Aurobindo Pharma Limited has received FDA approval for its generic version of dutasteride and tamsulosin hydrochloride capsules[4].

Sources

1. Business Research Insights: Tamsulosin Market Size, Trends & Growth Analysis by 2032.
2. FDA: 022460Orig1s000 - Dutasteride and Tamsulosin Hydrochloride (0.5mg/0.4mg) Combination Capsule.
3. PR Newswire: The World Generic Market Report 2012.
4. Chain Drug Review: Aurobindo gets FDA approval for dutasteride and tamsulosin hydrochloride capsules.
5. FDA: Jalyn (dutasteride and tamsulosin hydrochloride) capsules label.