Finasteride - Generic Drug Details

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

Finasteride is the generic ingredient in five branded drugs marketed by Accord Hlthcare, Actavis Totowa, Actavis Totowa Teva, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Gedeon Richter Usa, Hetero Labs Ltd Iii, Ivax Sub Teva Pharms, Mylan, Natco Pharma, Sun Pharm, Teva, Zydus Pharms Usa Inc, Organon, Blue Water Biotech, and Zydus Lifesciences, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for finasteride. Thirty-five suppliers are listed for this compound.

Summary for finasteride

US Patents:	0
Tradenames:	5
Applicants:	20
NDAs:	26
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	78
Patent Applications:	7,314
Drug Prices:	Drug price trends for finasteride
Drug Sales Revenues:	Drug sales revenues for finasteride
What excipients (inactive ingredients) are in finasteride?	finasteride excipients list
DailyMed Link:	finasteride at DailyMed

See drug prices for finasteride

See drug sales revenues for finasteride

Recent Clinical Trials for finasteride

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

Sponsor	Phase
Follicle Pharma Ltd	Phase 1
Mohammed Abd El Mawgoud Amer	N/A
Vanderbilt University Medical Center	Phase 2

See all finasteride clinical trials

Pharmacology for finasteride

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

Medical Subject Heading (MeSH) Categories for finasteride

5-alpha Reductase Inhibitors

Urological Agents

Anatomical Therapeutic Chemical (ATC) Classes for finasteride

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

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

US Patents and Regulatory Information for finasteride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ivax Sub Teva Pharms	FINASTERIDE	finasteride	TABLET;ORAL	076340-001	Jun 19, 2006		DISCN	No	No
Hetero Labs Ltd Iii	FINASTERIDE	finasteride	TABLET;ORAL	090061-001	Jun 7, 2010	AB	RX	No	No
Actavis Totowa Teva	FINASTERIDE	finasteride	TABLET;ORAL	077914-001	Mar 28, 2007		DISCN	No	No
Teva	FINASTERIDE	finasteride	TABLET;ORAL	076511-001	Dec 15, 2006	AB	RX	No	No
Hetero Labs Ltd Iii	FINASTERIDE	finasteride	TABLET;ORAL	090060-001	Jul 1, 2013	AB	RX	No	No

Expired US Patents for finasteride

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	PROPECIA	finasteride	TABLET;ORAL	020788-001	Dec 19, 1997	5,886,184
Organon	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	5,942,519
Organon	PROPECIA	finasteride	TABLET;ORAL	020788-001	Dec 19, 1997	4,377,584
Organon	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	4,760,071

Finasteride Market Analysis and Financial Projection Experimental

Finasteride Market Dynamics and Financial Trajectory

Introduction

Finasteride, a medication widely used for treating benign prostatic hyperplasia (BPH) and male pattern baldness, is experiencing significant growth in the global market. Here, we delve into the market dynamics and financial trajectory of finasteride, highlighting key drivers, challenges, and regional trends.

Market Size and Growth

The global finasteride market has demonstrated a steady growth trajectory. As of 2023, the market size was valued at approximately USD 109.5 million[1][4].

• By 2036, the market is anticipated to reach USD 154.82 million, growing at a compound annual growth rate (CAGR) of around 2.7%[1].
• Another forecast indicates that the market will grow at a CAGR of 3.0% from 2024 to 2031, reaching a size of USD 125.2 million in 2024[2].

Growth Drivers

Several factors are driving the growth of the finasteride market:

Increasing Prevalence of BPH and Hair Loss

• The rising cases of BPH and male pattern baldness are significant drivers. For instance, about half of men between the ages of 51 and 60 suffer from BPH, and 90% of men above 80 years have this disorder[1].
• Hair loss is becoming a significant issue, with approximately two-thirds of men expected to experience hair loss symptoms by the age of 35[4].

Growing Geriatric Population

• The rapid increase in the geriatric population is another key factor. Prostate cancer, for example, is more common among men aged 65 and older, with around 6 in 10 diagnosed cases belonging to this age group[1].

Consumer Spending and Awareness

• Increasing consumer spending on hair treatment products, especially in emerging economies, is driving market growth. The emphasis on physical appearance and the growing awareness of treatments for BPH and hair loss are also contributing factors[1][2].

Technological and Distribution Advancements

• The shift towards online pharmacies and e-commerce platforms is making finasteride more accessible. This trend is particularly pronounced in regions like North America and Asia Pacific, where the internet distribution channel is expanding rapidly[1][2].

Challenges

Despite the growth, the finasteride market faces several challenges:

Regulatory Environment

• Strong measures by governments, such as the U.S. government's focus on biosimilar and generic drug approvals, can impact the market dynamics. However, these measures also promote R&D activities in the pharma sector, which can drive industry growth in the long term[3].

Competition from Generic Drugs

• The increasing availability of generic finasteride medications can pose a challenge to branded products. However, consumer confidence in well-known pharmaceutical names continues to support the market for branded finasteride[2].

Market Segmentation

By Application

• The finasteride market is segmented into prostate treatment, hair treatment, and others. The prostate treatment segment is anticipated to hold the largest share due to the rising cases of BPH[1].
• The hair treatment segment is also expected to see notable growth due to the increasing incidence of alopecia among young adults[1].

By Distribution Channel

• The market is segmented by distribution channel into retail pharmacies, online pharmacies, and others. Online pharmacies are expected to witness the highest growth due to the consumer shift towards digital technology and the increasing number of online medical stores[1].

Regional Analysis

North America

• North America holds a significant share of the global finasteride market, with a market size of USD 50.08 million in 2024 and a CAGR of 1.2% from 2024 to 2031. The region's growth is driven by the increasing awareness of BPH and male pattern baldness, as well as the expanding internet distribution channel[2].

Asia Pacific

• The Asia Pacific region is set to hold the largest revenue share by 2036. The market here is driven by the growing penetration of finasteride in developing countries, rising awareness of BPH and hair loss, and the expansion of e-commerce platforms[1][2].

Europe

• Europe also constitutes a significant portion of the market, with a CAGR of 1.5% from 2024 to 2031. The region's growth is supported by the increasing incidence of BPH and hair loss, as well as the growing trust in branded pharmaceuticals[2].

Latin America and Middle East & Africa

• Latin America and the Middle East & Africa are also experiencing growth, albeit at a slower pace. These regions are driven by the growing middle class, developing healthcare systems, and increasing awareness of BPH and hair loss[2].

Financial Trajectory

Revenue Projections

• The global finasteride market is projected to grow from USD 109.5 million in 2023 to USD 154.82 million by 2036, with a CAGR of 2.7%[1].
• Another projection indicates the market will reach USD 128.77 million by 2032, growing at a CAGR of 2.8% from 2024[4].

Regional Revenue

• North America is expected to maintain its dominant position, with a market size of USD 50.08 million in 2024 and a CAGR of 1.2% from 2024 to 2031[2].
• The Asia Pacific region will see significant growth, with a CAGR of 5.0% from 2024 to 2031, driven by the expanding e-commerce sector and growing awareness of health issues[2].

Key Takeaways

• The finasteride market is driven by the increasing prevalence of BPH and hair loss, the growing geriatric population, and advancements in distribution channels.
• The market is segmented by application and distribution channel, with prostate treatment and online pharmacies showing significant growth potential.
• North America and Asia Pacific are key regions driving market growth, with Europe, Latin America, and the Middle East & Africa also contributing to the market's expansion.
• The market faces challenges from regulatory environments and competition from generic drugs but is expected to grow steadily over the forecast period.

FAQs

Q: What is the current market size of the finasteride market?

• The global finasteride market size was valued at approximately USD 109.5 million in 2023[1].

Q: What is the projected growth rate of the finasteride market?

• The market is anticipated to grow at a CAGR of around 2.7% from 2024 to 2036[1].

Q: Which region holds the largest share of the finasteride market?

• North America currently holds the largest share, but the Asia Pacific region is expected to hold the largest revenue share by 2036[1][2].

Q: What are the primary applications of finasteride?

• The primary applications are prostate treatment and hair treatment, with the prostate treatment segment holding the largest share[1].

Q: How is the distribution channel segment performing in the finasteride market?

• The online pharmacy segment is expected to witness the highest growth due to the consumer shift towards digital technology and the increasing number of online medical stores[1].

Sources

1. Research Nester - Finasteride Market Size & Share, Growth Report 2036[1]
2. Cognitive Market Research - Finasteride Market Report[2]
3. Global Market Insights - Finasteride Market Size, Share and Growth | Industry Report - 2026[3]
4. Polaris Market Research - Finasteride Market Statistics, Growth & Competitive Analysis 2032[4]