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. Fifteen 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:	92
Clinical Trials:	39
Patent Applications:	4,209
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
Radboud University Medical Center	Phase 2
Dongkook Pharmaceutical Co., Ltd.	Phase 3
Addpharma Inc.	Phase 1

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
European Patent Office	0783001	Androsténones (Androstenones)
Slovakia	281869
Spain	2113127
World Intellectual Property Organization (WIPO)	9507927

Supplementary Protection Certificates for AVODART

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0719278	03C0030	France		PRODUCT NAME: DUTASTERIDE; NAT. REGISTRATION NO/DATE: NL 28 131 20030327; FIRST REGISTRATION: SE - 17 871 20020719
0719278	23/2003	Austria		PRODUCT NAME: DUTASTERIDE, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SOLVATES; NAT. REGISTRATION NO/DATE: 1-24844, 1-24845 20030217; FIRST REGISTRATION: SE 17871, 17872 20020719
0719278	300122	Netherlands
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

Market Dynamics and Financial Trajectory for Avodart (Dutasteride)

Introduction

Avodart, known generically as dutasteride, is a medication primarily used to treat benign prostatic hyperplasia (BPH) or enlarged prostate in men. Here, we will delve into the market dynamics and financial trajectory of Avodart, highlighting key trends, drivers, and challenges.

Market Segmentation

The global dutasteride market is segmented based on type and end user.

By Type

• Avodart: The branded version of dutasteride, which is a significant segment due to its established market presence and brand loyalty.
• Generic Avodart: Generic versions of dutasteride, which have gained traction due to their cost-effectiveness and similar efficacy[1][4].

By End User

• Hospitals: Avodart is often prescribed and administered in hospital settings, particularly for severe cases of BPH.
• Drug Stores: Retail pharmacies also play a crucial role in the distribution of Avodart, catering to patients who prefer outpatient treatment[1][4].

Market Size and Growth

The global dutasteride market is expected to grow at a CAGR of 3 to 5 percent from 2024 to 2031. This growth is driven by increasing prevalence of BPH, aging populations, and the expanding availability of both branded and generic versions of the drug[4].

Regional Dynamics

North America

North America is the largest market for Avodart, driven by a high prevalence of BPH and a well-established healthcare system. The region saw significant sales in 2023, with a strong presence of major pharmaceutical companies like GSK and Teva[1][4].

Europe

Europe is another key market, with a growing demand for Avodart due to an aging population and increased awareness of BPH treatment options.

Asia-Pacific

The Asia-Pacific region is the fastest-growing market for Avodart, driven by increasing healthcare spending, a large patient population, and the rise of generic drug manufacturers[1].

Key Players and Competitive Landscape

The market for Avodart is highly competitive, with several major players:

• GSK: The original developer and marketer of Avodart, GSK continues to hold a significant market share despite the emergence of generic competitors[1][3].
• Bionpharma, Rising Pharmaceuticals, Teva, Mylan, Zydus, Amneal Pharma, Apotex, Marksans Pharma, Breckenridge Pharmaceutical: These companies offer both branded and generic versions of dutasteride, contributing to the market's competitive landscape[1][4].

Financial Performance

Revenue Growth

Recordati, a company that has acquired rights to Avodart in some regions, reported a significant increase in revenue from the drug. For the first nine months of 2024, the Urology franchise, which includes Avodart, saw a 51.4% growth, contributing €82.9 million to the company's revenue[2].

Market Share

GSK, the original manufacturer, continues to maintain a strong market share despite competition from generics. The company's financial reports indicate robust sales performance across its Specialty Medicines segment, which includes Avodart[3].

Drivers and Opportunities

Increasing Prevalence of BPH

The growing prevalence of BPH among aging men is a significant driver for the Avodart market. As populations age, the demand for effective treatments like Avodart is expected to rise[1][4].

Technological Innovations

While Avodart itself is not a new drug, innovations in delivery systems and formulations could enhance its market appeal. For instance, combination therapies like Combodart (dutasteride and tamsulosin) have shown promising results[2].

Expanding Generic Market

The availability of generic versions of Avodart has opened up the market to a broader patient base, particularly in regions where cost is a significant factor. This has driven growth and increased competition[1][4].

Challenges and Restraints

Competition from Generics

The entry of generic versions of dutasteride has posed a significant challenge to branded Avodart. Generic drugs offer similar efficacy at lower prices, which can erode the market share of the branded version[1][4].

Regulatory Environment

Changes in regulatory policies and patent expirations can impact the market dynamics. For example, the expiration of patents for Avodart has allowed generic manufacturers to enter the market[1].

Side Effects and Alternatives

Avodart, like other 5-alpha-reductase inhibitors, can have side effects such as sexual dysfunction and breast tenderness. These side effects and the availability of alternative treatments can deter some patients from using the drug[1].

Financial Highlights

Revenue and Profit Margins

For the first nine months of 2024, Recordati reported a consolidated net revenue of €1,743.1 million, with a significant contribution from the Urology franchise, which includes Avodart. The company's adjusted operating income and net income also saw double-digit growth, reflecting strong business momentum[2].

Cost and Operating Leverage

GSK's financial reports highlight the company's focus on cost discipline and operating leverage. Despite the challenges posed by generic competition, GSK has managed to maintain strong operating margins and cash flow, partly due to its diversified portfolio and strategic investments[3].

Key Takeaways

• The global dutasteride market is expected to grow at a CAGR of 3 to 5 percent from 2024 to 2031.
• North America and Europe are significant markets, with the Asia-Pacific region showing the fastest growth.
• GSK and other major pharmaceutical companies face competition from generic manufacturers.
• The market is driven by the increasing prevalence of BPH and the availability of both branded and generic versions of the drug.
• Regulatory changes and side effects are key challenges to the market.

FAQs

What is Avodart used for?

Avodart, or dutasteride, is primarily used to treat benign prostatic hyperplasia (BPH) or enlarged prostate in men.

Who are the major players in the Avodart market?

Major players include GSK, Bionpharma, Rising Pharmaceuticals, Teva, Mylan, Zydus, Amneal Pharma, Apotex, Marksans Pharma, and Breckenridge Pharmaceutical.

What is the expected growth rate of the global dutasteride market?

The global dutasteride market is expected to grow at a CAGR of 3 to 5 percent from 2024 to 2031.

Which region is the fastest-growing market for Avodart?

The Asia-Pacific region is the fastest-growing market for Avodart, driven by increasing healthcare spending and a large patient population.

How has the entry of generic versions affected the Avodart market?

The entry of generic versions has increased competition, eroding the market share of the branded version but also expanding the market to a broader patient base due to lower costs.

Sources

1. Market Research Engine: Dutasteride Market Size, Share, Analysis Report.
2. Biospace: RECORDATI: CONTINUED DOUBLE-DIGIT GROWTH IN THE FIRST NINE MONTHS OF 2024.
3. GSK: Annual Report 2023.
4. Market Research Intellect: Global Dutasteride Market Size And Forcast.