Finasteride; tadalafil - Generic Drug Details

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

Finasteride; tadalafil is the generic ingredient in two branded drugs marketed by Blue Water Biotech and Zydus Lifesciences, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for finasteride; tadalafil

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Clinical Trials:	2
DailyMed Link:	finasteride; tadalafil at DailyMed

Recent Clinical Trials for finasteride; tadalafil

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

Sponsor	Phase
Vanderbilt University Medical Center	Phase 2
Eli Lilly and Company	Phase 3

See all finasteride; tadalafil clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for finasteride; tadalafil

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

G04BE	Drugs used in erectile dysfunction
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

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

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; tadalafil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Blue Water Biotech	ENTADFI	finasteride; tadalafil	CAPSULE;ORAL	215423-001	Dec 9, 2021		DISCN	Yes	No
Zydus Lifesciences	FINASTERIDE AND TADALAFIL	finasteride; tadalafil	CAPSULE;ORAL	218232-001	Mar 15, 2024		DISCN	No	No

Market Dynamics and Financial Trajectory for Finasteride and Tadalafil

Introduction to Finasteride and Tadalafil

Finasteride and tadalafil are two widely used medications with distinct therapeutic applications. Finasteride is primarily used to treat male pattern baldness and benign prostatic hyperplasia (BPH), while tadalafil is used to treat erectile dysfunction (ED), BPH, and pulmonary arterial hypertension.

Finasteride Market Dynamics

Market Size and Growth

The global finasteride market was valued at approximately USD 102.21 million in 2023 and is expected to grow to USD 128.77 million by 2032, exhibiting a CAGR of 2.8% during the forecast period[1][4][5].

Key Drivers

• Increasing Prevalence of Hair Loss and BPH: The rising incidence of male pattern baldness and BPH are significant drivers. Approximately two-thirds of men are expected to experience hair loss by the age of 35, and nearly 90% of men above 80 years suffer from BPH[1][4][5].
• Geriatric Population: The growing geriatric population is another key factor, as older men are more prone to BPH and hair loss[4][5].
• R&D Activities: Continuous research and development in the pharmaceutical industry, particularly in emerging economies, are driving market growth[4][5].

Market Segmentation

• Application: The market is segmented into prostate treatment, hair treatment, and others. The prostate treatment segment is expected to hold the largest share due to the high prevalence of BPH[4].
• Distribution Channel: Online pharmacies are anticipated to witness the highest growth due to the increasing use of digital technology and online medical stores[4].

Regional Insights

• Asia Pacific: This region is expected to hold the largest revenue share by 2036, driven by the growing penetration of finasteride in developing countries and the expansion of pharmaceutical companies' sales networks[4].
• North America: This region is also expected to witness significant growth due to the rise in prevalence of male pattern baldness and advanced healthcare infrastructure[5].

Tadalafil Market Dynamics

Market Size and Growth

The global tadalafil market was valued at USD 6.25 billion in 2024 and is expected to grow to USD 17.00 billion by 2034, with a CAGR of 11.6% during the forecast period[2][3].

Key Drivers

• Increasing Awareness of Men's Health: Growing awareness and acceptance of treatments for ED and BPH are driving the market. The aging population and the need for efficient treatment options are also significant factors[2][3].
• Formulation Innovations: Advances in formulations, such as combination therapies and once-daily dosages, are improving patient adherence and satisfaction[3].

Market Segmentation

• Application: Tadalafil is used for ED, BPH, and pulmonary arterial hypertension. The ED segment is particularly strong, especially in North America[2].
• Region: North America dominates the market, followed by the Asia Pacific, which offers significant growth potential due to rising disposable incomes and urbanization[2].

Regional Insights

• North America: This region is a developed market where tadalafil is well-known, especially for treating ED. Increased awareness campaigns and educational materials are boosting prescriptions[2].
• Asia Pacific: This region offers a substantial potential market due to growing awareness of men's health issues, rising disposable incomes, and expanding urbanization[2].

Financial Trajectory for Finasteride

Revenue Projections

• The finasteride market is projected to grow from USD 102.21 million in 2023 to USD 128.77 million by 2032, with a CAGR of 2.8%[1].
• Another projection indicates the market will reach USD 154.82 million by 2036, growing at a CAGR of 2.7% from 2024 to 2036[4].

Impact of Pandemic

• The market was negatively impacted during the COVID-19 pandemic due to disrupted global supply chains and delays in clinical trials[5].

Financial Trajectory for Tadalafil

Revenue Projections

• The tadalafil market is expected to grow from USD 6.25 billion in 2024 to USD 17.00 billion by 2034, with a CAGR of 11.6%[2].
• An alternative projection suggests the market will reach USD 4.8 billion by 2031, growing at a CAGR of 4.9% from 2024 to 2031[3].

Key Players

• Major players in the tadalafil market include Glenmark Pharmaceuticals Ltd., Teva Pharmaceutical Industries Ltd., Eli Lilly and Co. Pvt. Ltd., and others[2].

Challenges and Restraints

Finasteride

• Side Effects: Potential side effects such as decreased libido and erectile dysfunction can act as market restraints[4].
• Regulatory Issues: Regulatory frameworks and healthcare systems can influence market dynamics, particularly in regions with stringent regulations[5].

Tadalafil

• Adverse Reactions: Possible adverse reactions are a significant market restraining factor[2].
• Access to Healthcare: Limited access to healthcare facilities and specialists in certain regions can restrict market growth[2].

Future Outlook

Finasteride

• The market is expected to benefit from increasing healthcare expenditure in emerging economies and the growing emphasis on physical appearance, particularly among young adults[4][5].

Tadalafil

• The Asia Pacific region is anticipated to offer significant growth opportunities due to rising awareness of men's health issues and increasing disposable incomes[2].

"According to the American Cancer Society, in the year 2021, about 248,530 new cases of prostate cancer were estimated in the United States. Moreover, around 6 in 10 of the diagnosed cases belonged to men who were 65 years or older."[4]

Key Takeaways

• Finasteride: The market is driven by the increasing prevalence of hair loss and BPH, with significant growth expected in the Asia Pacific region.
• Tadalafil: The market is driven by growing awareness of men's health issues, formulation innovations, and strong demand in North America and the Asia Pacific.
• Financial Trajectory: Both markets are expected to grow, with finasteride reaching USD 128.77 million by 2032 and tadalafil reaching USD 17.00 billion by 2034.
• Challenges: Both markets face challenges such as potential side effects and limited access to healthcare in certain regions.

FAQs

1. What are the primary uses of finasteride and tadalafil?

• Finasteride is primarily used to treat male pattern baldness and benign prostatic hyperplasia (BPH). Tadalafil is used to treat erectile dysfunction (ED), BPH, and pulmonary arterial hypertension.

2. What are the key drivers of the finasteride market?

• The key drivers include the increasing prevalence of hair loss and BPH, the growing geriatric population, and ongoing R&D activities in the pharmaceutical industry.

3. How is the tadalafil market segmented?

• The tadalafil market is segmented by purity, form, application, and region. The ED segment is particularly strong, especially in North America.

4. What are the regional insights for the finasteride market?

• The Asia Pacific region is expected to hold the largest revenue share by 2036, driven by the growing penetration of finasteride in developing countries.

5. What are the potential challenges for the tadalafil market?

• Potential challenges include adverse reactions and limited access to healthcare facilities and specialists in certain regions.

Sources:

1. Polaris Market Research - Finasteride Market Statistics, Growth & Competitive Analysis 2032
2. Prophecy Market Insights - Tadalafil Market Size Global Report, 2024 – 2034
3. Market Research Intellect - Tadalafil Market Size and Projections - Market Research Intellect
4. Research Nester - Finasteride Market Size & Share, Growth Report 2036
5. Allied Market Research - Finasteride Market Statistics, Regional Analysis | Forecast - 2031