Dutasteride - Generic Drug Details

What are the generic drug sources for dutasteride and what is the scope of patent protection?

Dutasteride is the generic ingredient in four branded drugs marketed by Waylis Therap, Acella, Actavis Labs Fl Inc, Adaptis, Amneal Pharms, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Barr, Chartwell, Heritage Pharms Inc, Hikma, Humanwell Puracap, Norvium Bioscience, Nostrum Labs Inc, Rising, Strides Pharma, Vintage, Zydus Lifesciences, Aurobindo Pharma, Endo Operations, and Zydus Pharms, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for dutasteride. Eighteen suppliers are listed for this compound.

Summary for dutasteride

US Patents:	0
Tradenames:	4
Applicants:	22
NDAs:	25
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	111
Patent Applications:	6,359
Drug Prices:	Drug price trends for dutasteride
What excipients (inactive ingredients) are in dutasteride?	dutasteride excipients list
DailyMed Link:	dutasteride at DailyMed

See drug prices for dutasteride

See drug sales revenues for dutasteride

Recent Clinical Trials for dutasteride

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

Sponsor	Phase
Masonic Cancer Center, University of Minnesota	Phase 2
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal	Phase 2
Radboud University Medical Center	Phase 2

See all dutasteride clinical trials

Pharmacology for dutasteride

Drug Class	5-alpha Reductase Inhibitor
Mechanism of Action	5-alpha Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for dutasteride

5-alpha Reductase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dutasteride

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AVODART	Capsules	dutasteride	0.5 mg	021319	1	2007-10-29

US Patents and Regulatory Information for dutasteride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nostrum Labs Inc	DUTASTERIDE	dutasteride	CAPSULE;ORAL	204705-001	Nov 20, 2015		DISCN	No	No
Norvium Bioscience	DUTASTERIDE	dutasteride	CAPSULE;ORAL	203241-001	Jun 14, 2016		DISCN	No	No
Adaptis	DUTASTERIDE	dutasteride	CAPSULE;ORAL	204376-001	Apr 7, 2017	AB	RX	No	No
Actavis Labs Fl Inc	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	202975-001	Nov 20, 2015		DISCN	No	No
Humanwell Puracap	DUTASTERIDE	dutasteride	CAPSULE;ORAL	209909-001	Nov 21, 2017	AB	RX	No	No

Expired US Patents for dutasteride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	AVODART	dutasteride	CAPSULE;ORAL	021319-001	Nov 20, 2001
Waylis Therap	AVODART	dutasteride	CAPSULE;ORAL	021319-001	Nov 20, 2001
Waylis Therap	AVODART	dutasteride	CAPSULE;ORAL	021319-001	Nov 20, 2001

Dutasteride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dutasteride

Introduction

Dutasteride, marketed under the brand name Avodart among others, is a medication primarily used to treat benign prostatic hyperplasia (BPH) in men. This article delves into the market dynamics and financial trajectory of dutasteride, highlighting key segments, drivers, restraints, and future projections.

Market Segmentation

The global dutasteride market is segmented based on several criteria:

By Type

• Avodart: The branded version of dutasteride, which has been a significant player in the market since its introduction.
• Generic Avodart: With the patent expiry of Avodart, generic versions have entered the market, offering a more affordable alternative[1][4].

By End User

• Hospitals: Dutasteride is prescribed and administered in hospital settings, particularly for severe cases of BPH.
• Drug Stores: The medication is also available through retail pharmacies, catering to patients who prefer outpatient treatment[1][4].

By Geography

The market is analyzed across various regions, including North America, Europe, Asia-Pacific, and the Rest of the World. North America currently holds the largest market share due to a higher prevalence of BPH and advanced healthcare infrastructure[1][3].

Market Drivers

Several factors drive the growth of the dutasteride market:

Increasing Prevalence of BPH

The rising incidence of benign prostatic hyperplasia, particularly among the aging population, is a significant driver. As the global population ages, the demand for BPH treatments is expected to increase[3].

Expired Patents and Generic Availability

The expiry of patents for branded dutasteride has led to the entry of generic versions, making the medication more accessible and affordable. This has expanded the market reach and increased sales volumes[3][4].

Economic Benefits

Studies have shown that dutasteride can reduce medical costs compared to other treatments like finasteride. Patients treated with dutasteride incur lower monthly medical costs, which can be a compelling factor for healthcare plans and patients alike[2].

Market Restraints

Despite the growth drivers, there are several restraints to consider:

Competition from Established Players

New vendors face strong competition from established international vendors, who have a strong foothold in the market. Technological innovations, reliability, and quality issues can hinder the entry of new players[1].

Side Effects and Safety Concerns

Dutasteride, like other 5-alpha reductase inhibitors, can have side effects such as sexual dysfunction, which can affect patient compliance and market growth[5].

Financial Trajectory

The financial outlook for the dutasteride market is promising:

Market Size and Growth

The global dutasteride market is expected to grow at a CAGR of 3 to 5% from 2024 to 2031. The market size is projected to increase significantly, driven by the factors mentioned above[4].

Regional Performance

North America is currently the largest market for dutasteride, followed by Europe and Asia-Pacific. The Asia-Pacific region is expected to be the fastest-growing market due to increasing healthcare spending and a growing geriatric population[1][3].

Revenue Projections

The benign prostatic hyperplasia treatment market, which includes dutasteride, is forecasted to grow from $10.8 billion in 2021 to $14.1 billion by 2026, at a CAGR of 5.3%[3].

Competitive Landscape

The market is highly competitive with several key players:

Major Players

Companies like GSK, Bionpharma, Rising Pharmaceuticals, Teva, Mylan, Zydus, Amneal Pharma, Apotex, Marksans Pharma, and Breckenridge Pharmaceutical are major participants. These companies are involved in various growth and expansion strategies, including value chain integration and product innovation[1][4].

Economic Evaluation

A real-world economic evaluation comparing dutasteride and finasteride found that patients treated with dutasteride incurred $20.50 less per month in medical costs. This reduction is significant and can influence healthcare plans' decisions when evaluating these treatments[2].

Product Pipeline and Generics

The expiry of patents for branded BPH medications, including Avodart, has opened up opportunities for generic manufacturers. The availability of generics has increased access to treatment, although it may affect overall revenue in the short term due to lower prices[3].

Conclusion on Market Dynamics

The dutasteride market is driven by increasing demand for BPH treatments, the availability of generics, and economic benefits. However, it faces competition from established players and side effect concerns. The market is expected to grow steadily, with significant contributions from the Asia-Pacific region.

Key Takeaways

• The global dutasteride market is segmented by type (Avodart and Generic Avodart), end user (hospitals and drug stores), and geography.
• The market is driven by the increasing prevalence of BPH, expired patents, and economic benefits.
• North America is the largest market, but the Asia-Pacific region is expected to be the fastest-growing.
• Major players include GSK, Bionpharma, and others, who are involved in various growth strategies.
• The market is expected to grow at a CAGR of 3 to 5% from 2024 to 2031.

FAQs

What is the current market size of the global dutasteride market?

The current market size of the global dutasteride market is estimated to be in the range of several hundred million USD, with precise figures varying by source and year[1][4].

How does dutasteride compare to finasteride in terms of cost?

Patients treated with dutasteride incur $20.50 less per month in medical costs compared to those treated with finasteride[2].

What are the major regions for the dutasteride market?

The major regions include North America, Europe, Asia-Pacific, and the Rest of the World, with North America currently holding the largest market share[1][3].

What is the impact of generic versions on the dutasteride market?

Generic versions of dutasteride have increased access to the medication, although they may affect overall revenue due to lower prices. This has led to higher sales volumes overall[3][4].

What are the common side effects of dutasteride?

Common side effects include sexual dysfunction, which can be reversible. Other side effects may also occur, but sexual dysfunction is the most commonly reported[5].

Sources

1. Market Research Engine: Dutasteride Market Size, Share, Analysis Report | Marketresearch
2. PubMed: Finasteride versus dutasteride: a real-world economic evaluation
3. MarketsandMarkets: Benign Prostatic Hyperplasia Treatment Market
4. Market Research Intellect: Global Dutasteride Market Size And Forcast
5. Indian Journal of Dermatology, Venereology and Leprology: Superiority of dutasteride over finasteride in hair regrowth and reversal of miniaturization in men with androgenetic alopecia: a randomized controlled open-label evaluator-blinded study