PROSCAR Drug Patent Profile

When do Proscar patents expire, and what generic alternatives are available?

Proscar is a drug marketed by Organon and is included in one NDA.

The generic ingredient in PROSCAR is finasteride. There are fourteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the finasteride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Proscar

A generic version of PROSCAR was approved as finasteride by DR REDDYS LABS INC on July 28^th, 2006.

Summary for PROSCAR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	22
Patent Applications:	3,500
Drug Prices:	Drug price information for PROSCAR
What excipients (inactive ingredients) are in PROSCAR?	PROSCAR excipients list
DailyMed Link:	PROSCAR at DailyMed

See drug prices for PROSCAR

Recent Clinical Trials for PROSCAR

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

Sponsor	Phase
Baylor College of Medicine	Phase 3
Astellas Pharma Korea, Inc.	Phase 4
Seoul National University Hospital	Phase 4

See all PROSCAR clinical trials

Pharmacology for PROSCAR

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

US Patents and Regulatory Information for PROSCAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	AB	RX	Yes	Yes

Expired US Patents for PROSCAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	6,046,183
Organon	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	4,377,584
Organon	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	5,942,519
Organon	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	5,886,184
Organon	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	4,760,071

International Patents for PROSCAR

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

Country	Patent Number	Title	Estimated Expiration
Iceland	4034
Japan	S63139196	17 BETA-ACYL-4-AZA-5 ALPHA-ANDROST-1-ENE-3-ONES BEING 5 ALPHA REDUCTASE INHIBITOR
Australia	527030
Singapore	128794
Slovakia	65995	PROCESS FOR PRODUCTION OF FINASTERIDE AND INTERMEDIATES FOR REALIZATION OF THIS METHOD

Supplementary Protection Certificates for PROSCAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0155096	SPC/GB93/006	United Kingdom		SPC/GB93/006:, EXPIRES: 20070526
0155096	93C0055	Belgium		PRODUCT NAME: FINASTERIDUM; NAT. REG..: 922 IS 151 F 3 19930125; FIRST REG.: GB PL 0025/0279 19920527

PROSCAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Finasteride (Proscar)

Introduction to Finasteride (Proscar)

Finasteride, commonly known by the brand name Proscar, is a medication used to treat benign prostatic hyperplasia (BPH) and male pattern baldness (androgenetic alopecia). The drug has been a significant player in the pharmaceutical market, driven by increasing demand for effective treatments for these conditions.

Global Market Size and Growth

The global finasteride market has demonstrated steady growth over the years. As of 2021, the market size was valued at $362.1 million and is projected to reach $546.7 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.2% from 2022 to 2031[4][5].

Key Drivers of Market Growth

Increasing Demand for Effective Treatments

The rising demand for effective treatments for male pattern baldness and BPH is a significant driver of the finasteride market. Consumers, especially in Europe and emerging economies, are increasingly focusing on physical appearance, which has led to higher demand for finasteride[1][3].

Expansion of Pharmaceutical Sector

The expansion of the pharmaceutical sector, particularly in countries like China and India, has contributed to the growth of the finasteride market. Lower costs of finasteride drugs in these regions have made them more accessible, thereby increasing market penetration[1][4].

Healthcare Infrastructure and Expenditure

The rise in healthcare expenditure in emerging economies and the development of advanced healthcare infrastructure in regions like North America have boosted the demand for finasteride. This infrastructure supports better diagnosis and treatment of BPH and male pattern baldness, driving market growth[4].

Online Pharmacies and Supply Chain Management

The increasing adoption of online pharmacies and improved supply chain management within the distribution channels have positively impacted the market. These factors have made finasteride more accessible to a wider audience, contributing to market expansion[1][3].

Regional Market Analysis

North America

North America is expected to witness the highest growth in terms of revenue due to the rise in prevalence of male pattern baldness cases and the presence of advanced healthcare infrastructure. Increased awareness about finasteride in this region also contributes to its market dominance[4].

Asia-Pacific

The Asia-Pacific region, particularly China and India, is anticipated to witness notable growth. This is driven by an increase in BPH cases, the rise of key players offering finasteride, and significant investments in the development of finasteride[1][4].

Europe

Europe has seen a significant increase in finasteride usage, primarily due to a higher focus on physical appearance among consumers. This region continues to be a key market for finasteride, driven by consumer demand and the availability of the drug at competitive prices[1].

Financial Trajectory

Revenue and Growth

The finasteride market has shown a steady financial trajectory. For instance, the market size exceeded $110 million in 2019 and is estimated to grow to $130 million by 2026, with a CAGR of 2.9% between 2020 and 2026[3].

Key Players and Strategies

Major pharmaceutical companies such as Merck, Teva Pharmaceuticals, and Cipla are driving the market through various strategies. These include mergers and acquisitions, investments in bio-pharmaceuticals, and the development and manufacturing of innovative drugs. These strategies are aimed at increasing their revenue share and expanding market presence[1][3].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the global finasteride market. Restrictions on production and supply chain disruptions affected the availability of finasteride drugs. However, the market is expected to recover as these restrictions are lifted and supply chains are restored[1].

Competitive Landscape

Market Players

Key players in the finasteride market are adopting various strategies to increase their market share. These include expanding their product portfolios, enhancing distribution networks, and investing in research and development to create more effective and affordable finasteride drugs[1][3].

Distribution Channels

Hospital pharmacies are the leading distribution channels for finasteride, catering to a high number of patients. Institutional sales of finasteride drugs account for a higher share in the market, indicating a strong presence in healthcare settings[1].

Challenges and Restraints

Awareness and Purchasing Power

Less awareness about treatment options for BPH in certain regions and lower purchasing power of consumers in areas like the Middle East and Africa are significant challenges to the global finasteride market. These factors can limit market growth and penetration in these regions[1][4].

Regulatory and Economic Factors

Regulatory changes, such as strong measures by the U.S. government towards biosimilar and generic drug approvals, can impact the market. Additionally, economic factors like foreign exchange translation and higher costs of sales can affect the financial performance of companies involved in the finasteride market[2][3].

Future Outlook

Increasing Demand and R&D Activities

The future outlook for the finasteride market is positive, driven by increasing demand for treatments of BPH and male pattern baldness. Continuous R&D activities and the development of new products will further stimulate market growth[4].

Expanding Consumer Spending

Expanding consumer spending on hair treatment products, especially in emerging economies, will continue to support market demand. Social media and the emphasis on physical appearance will also play a crucial role in driving consumer demand for finasteride[3].

"Market players are focusing on mergers and the acquisitions to gain competitive advantage. They are also investing in development of bio-pharmaceuticals, which will create opportunities for into finasteride market expansion," said a Fact MR analyst[1].

Key Takeaways

• The global finasteride market is projected to grow significantly, driven by increasing demand for effective treatments for BPH and male pattern baldness.
• North America and Asia-Pacific are expected to be key regions for market growth.
• Hospital pharmacies and institutional sales are crucial distribution channels.
• Awareness and purchasing power in certain regions remain significant challenges.
• Continuous R&D and investments in bio-pharmaceuticals will drive market expansion.

FAQs

What is finasteride used for?

Finasteride is used to treat male pattern baldness (androgenetic alopecia) and benign prostatic hyperplasia (BPH)[4].

Which region is expected to witness the highest growth in the finasteride market?

North America is expected to witness the highest growth in terms of revenue due to the rise in prevalence of male pattern baldness cases and advanced healthcare infrastructure[4].

What are the key drivers of the finasteride market?

Key drivers include increasing demand for effective treatments, expansion of the pharmaceutical sector, and improvements in healthcare infrastructure and expenditure[1][4].

How has the COVID-19 pandemic impacted the finasteride market?

The pandemic has caused disruptions in production and supply chain activities, but the market is expected to recover as restrictions are lifted[1].

Which companies are major players in the finasteride market?

Major players include Merck, Teva Pharmaceuticals, and Cipla, among others[1][3].

Sources

1. Fact MR: Finasteride Market Will Expand as Demand for Effective Benign Prostate Hyperplasia Treatment Rises[1].
2. Organon: Organon Reports Results for the Fourth Quarter and Full Year Ended December 31, 2023[2].
3. GMI Insights: Finasteride Market Size, Share and Growth | Industry Report - 2026[3].
4. Allied Market Research: Finasteride Market Statistics, Regional Analysis | Forecast - 2031[4].
5. PR Newswire: Global Finasteride Market Analysis and Forecasts, 2021-2022 & 2031[5].