AVODART Drug Patent Profile

Which patents cover Avodart, and when can generic versions of Avodart launch?

Avodart is a drug marketed by Waylis Therap and is included in one NDA.

The generic ingredient in AVODART is dutasteride. There are eighteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dutasteride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Avodart

A generic version of AVODART was approved as dutasteride by BARR on December 21^st, 2010.

Summary for AVODART

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	40
Patent Applications:	5,009
Drug Prices:	Drug price information for AVODART
What excipients (inactive ingredients) are in AVODART?	AVODART excipients list
DailyMed Link:	AVODART at DailyMed

See drug prices for AVODART

See drug sales revenues for AVODART

Recent Clinical Trials for AVODART

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

Sponsor	Phase
Bio-innova Co., Ltd	PHASE1
Radboud University Medical Center	Phase 2
Dongkook Pharmaceutical Co., Ltd.	Phase 3

See all AVODART clinical trials

Pharmacology for AVODART

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

Paragraph IV (Patent) Challenges for AVODART

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 AVODART

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Waylis Therap	AVODART	dutasteride	CAPSULE;ORAL	021319-001	Nov 20, 2001	AB	RX	Yes	Yes

Expired US Patents for AVODART

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

International Patents for AVODART

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

Country	Patent Number	Title	Estimated Expiration
Luxembourg	91027
Czech Republic	286069	17beta-N-(2,5-bis-(trifluormethyl))fenylkarbamoyl-4-aza-5alfa-androst-1-en-3-on, způsob jeho výroby, jeho použití, farmaceutický prostředek s jeho obsahem a meziprodukt pro jeho výrobu (17beta-N-(2,5-bis-(trifluoromethyl))phenylcarbamoyl-4-aza-5alpha-androst-1-en-3-one, process of its preparation, its use, pharmaceutical preparation containing thereof and intermediate for its preparation)
Singapore	52650	Androstenone derivative
Finland	961231
African Intellectual Property Organization (OAPI)	10575	Androstenone derivative

Supplementary Protection Certificates for AVODART

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0719278	PA2003007	Lithuania		PRODUCT NAME: DUTASTERIDUM (17BETA-N(2,5-BIS(TRIFLUORMETIL)FENILKARBAMOIL-4-AZA-5ALFA-ANDROST-1-EN-3-ONAS), PASIRINKTINAI FARMACISKAI TINKAMO SOLVATO FORMOJE; REGISTRATION NO/DATE: 03/8183/7 20030909
0719278	SPC009/2005	Ireland		SPC009/2005: 20060316, EXPIRES: 20170718
0719278	PA 2003 007, C 0719278 /L	Lithuania
0719278	PA2003007,C0719278	Lithuania		PRODUCT NAME: DUTASTERIDUM (17BETA-N(2,5-BIS(TRIFLUORMETIL)FENILKARBAMOIL-4-AZA-5ALFA-ANDROST-1-EN-3-ONAS), PASIRINKTINAI FARMACISKAI TINKAMO SOLVATO FORMOJE; REGISTRATION NO/DATE: 03/8183/7 20030909
0719278	C300122	Netherlands		PRODUCT NAME: DUTASTERIDUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT; NAT. REGISTRATION NO/DATE: RVG 28317RVG 28318 2002161216; FIRST REGISTRATION: 1787117872 2002190719

Market Dynamics and Financial Trajectory for AVODART (Dutasteride)

Last updated: December 9, 2025

Executive Summary

AVODART (dutasteride) is a prescription medication primarily used to treat benign prostatic hyperplasia (BPH) and has shown promise in other indications like male pattern baldness. As of 2023, the drug faces evolving market dynamics driven by demographic shifts, regulatory landscapes, competitive drugs, and emerging therapies. It is projected to maintain moderate growth over the next five years, influenced by patent exclusivity, healthcare policy changes, and competitive pressures. This report analyzes current market forces, revenue forecasts, competitive landscape, regulatory environment, and the financial outlook for AVODART, providing essential insights for stakeholders.

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What Are the Current Market Dynamics Affecting AVODART?

1. Therapeutic Market Overview

Indication	Market Size (2022, USD billion)	Key Drivers
Benign Prostatic Hyperplasia (BPH)	$6.5	Aging male population, increasing diagnosis rates
Male Pattern Baldness	$5.2	Rising awareness, off-label use in dermatology

Source: IQVIA, 2022; GlobalData, 2023

2. Demographic Trends Impacting Demand

• Aging Population: The global male population aged 50+ is expected to grow by 35% between 2020 and 2030, bolstering BPH treatment needs.
• Increasing Diagnosis Rates: Greater physician awareness and improvements in diagnostic criteria expand eligible patient pools.

3. Competitive Landscape Analysis

Competitors	Mechanism of Action	Market Share (2022)	Key Features
Proscar (finasteride)	5α-reductase inhibitor	~40%	Established, generic available
Tamsulosin (Flomax)	Alpha-1 blocker	~30%	Symptom relief, separate class
Newer 5α-reductase inhibitors	E.g., finasteride, other dutasteride formulations	Remaining	Patents expiring, biosimilars emerging

Note: Dutasteride (AVODART) holds approximately 25% of the BPH market share, with revenues affected by generic entry and competitor innovation.

4. Patent and Regulatory Timeline

• Original Patent (Dutasteride): Expired in the U.S. in 2018, opening market to generics.
• Regulatory Approvals: Approved in over 80 countries; ongoing approvals for expanded indications or formulations.

Implication: Patent expiry has led to increased generic competition, reducing drug prices and profit margins.

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What Are the Revenue and Financial Trajectories for AVODART?

1. Revenue Trends (2018–2023)

Year	Global Sales (USD millions)	Key Factors
2018	$540	Patent expiry initiating generic entry
2019	$430	Increased generic competition
2020	$340	Pricing pressures, market saturation
2021	$290	Continued generic penetration, consolidation
2022	$250	Market stabilization, emergence of biosimilars

Sources: IQVIA MAT Reports, 2023

2. Forecast for 2023–2028

Year	Projected Revenue (USD millions)	Assumptions
2023	$220	Market maturity, increased biosimilar competition
2024	$200	Slight decline, generic proliferation continues
2025	$180	Developing new indications or formulations (e.g., topical delivery)
2026	$170	Potential entry of combination therapies
2027	$160	Price reductions due to biosimilars, patent cliff effects

Overall CAGR (2023–2028): Approximately -2%

Note: The trend reflects a plateau with slight decline, typical for off-patent drugs with generic competition.

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What Are Strategic Opportunities and Risks?

Opportunities

• Expanded Indications: Clinical trials exploring dutasteride in hair regrowth (male pattern baldness) and other androgenic conditions could diversify revenue streams.
• Formulation Innovations: Topical or localized delivery methods could command premium pricing.
• Market Penetration in Emerging Countries: Growing healthcare access and regulatory approvals could open new markets, e.g., Asia-Pacific.

Risks

• Patent Litigation and Biosimilar Entries: Accelerate price erosion and market share loss.
• Regulatory Barriers: Stringent approval requirements, especially for new indications.
• Pricing Pressures: Payor policies favoring generics and biosimilars reduce profitability.
• Market Saturation: Limited room for growth in mature markets.

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How Does AVODART Compare with Competitors?

Parameter	AVODART (Dutasteride)	Finasteride (Proscar)	Tamsulosin (Flomax)	Emerging Drugs
Mechanism of Action	5α-reductase inhibitor	5α-reductase inhibitor	Alpha-1 blocker	Other pathways (e.g., PDE5 inhibitors)
Patent Status	Expired (2018 in US)	Expired	Patent expiry pending	Under development
Market Share (2022, %)	~25%	~40%	~30%	Fragmented competition
Typical Price (USD/tablet)	~$2–$3	~$1–$2	~$1	Variable, often higher
Approved Indications	BPH, off-label for baldness	BPH, baldness	BPH, prostate symptoms	BPH, alopecia, others

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What Are Regulatory and Policy Trends Influencing AVODART?

1. Patent and Exclusivity Policies

• Patent Expiry: Leads to increased generic competition.
• Data Exclusivity: Typically 5–7 years in major markets; expiration accelerates commoditization.

2. Healthcare Policies

• Pricing Regulations: Countries like Canada and parts of Europe implement price caps.
• Reimbursement Strategies: Shifts towards value-based care may pressure margins for branded drugs.

3. Emerging Legislation

• Biosimilar and generic incentives: Accelerate entry and market share shifts.
• Approval pathways: Streamlining for new formulations or indications, e.g., topical dutasteride.

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Comparative Analysis: Key Market Factors

Aspect	AVODART	Competitor Drugs
Origin	Branded (GlaxoSmithKline)	Generic (Finasteride) or established brands
Price Trend	Declining due to patent expiration	Lower, with increasing biosimilar competition
Market Share	Stable but declining	Increasing, especially for generics
Regulatory Environment	Mature, with ongoing approval for new uses	Competitive, evolving rapidly

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Key Takeaways

• Market Maturity: AVODART faces a contracting market driven by generic displacement, with revenues declining approximately 2% annually post-2023.
• Growth Limitations: Limited prospects for growth in traditional indications; innovation and diversification are critical.
• Competitive Landscape: Dominated by first-generation 5α-reductase inhibitors; newer therapies and formulations remain on the horizon.
• Strategic Focus: Investment in expanded indications, formulation innovation, and emerging markets could provide relief from patent and pricing pressures.
• Regulatory Dynamics: Ongoing patent challenges and biosimilar entries necessitate vigilant patent management and diversification strategies.

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FAQs

Q1: How has patent expiry impacted AVODART’s market share?
A: Patent expiry in the U.S. in 2018 opened markets to generics, leading to price competition and a decline from peak sales of over $540 million in 2018 to approximately $220 million in 2023.

Q2: What are the primary competitive advantages of AVODART over its rivals?
A: Its longer duration of action and clinical efficacy in reducing prostate volume distinguish it. However, brands like finasteride have broader marketing reach and lower prices.

Q3: Are there promising new indications for dutasteride?
A: Yes. Clinical trials are exploring its use in male pattern baldness, prostate cancer risk reduction, and possibly in combination therapies, which could diversify revenue sources.

Q4: What is the outlook for AVODART’s revenue in the next five years?
A: Expect a gradual decline with an approximate CAGR of -2%, stabilizing as biosimilar competition consolidates and new formulations or indications are developed.

Q5: How are regulatory policies influencing AVODART’s market?
A: Patent regulations, biosimilar pathways, and pricing policies are increasing market competition and pressure on profitability. Companies must adapt through innovation and market expansion.

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Sources

1. IQVIA. Medicines & Outcomes Reports, 2023.
2. GlobalData. Benign Prostatic Hyperplasia Market Analysis, 2023.
3. U.S. Patent and Trademark Office. Patent Status for Dutasteride, 2023.
4. FDA & EMA Approvals Database, 2022–2023.
5. GSK Corporate Reports, 2023.

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In summary, AVODART’s future hinges on innovative strategies amidst a declining but historically significant market segment. Navigating patent expirations, enhancing indications, and tapping into emerging markets are pivotal for sustained financial performance.