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Last Updated: December 22, 2024

FINASTERIDE AND TADALAFIL Drug Patent Profile


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When do Finasteride And Tadalafil patents expire, and when can generic versions of Finasteride And Tadalafil launch?

Finasteride And Tadalafil is a drug marketed by Zydus Lifesciences and is included in one NDA.

The generic ingredient in FINASTERIDE AND TADALAFIL is finasteride; tadalafil. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the finasteride; tadalafil profile page.

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Summary for FINASTERIDE AND TADALAFIL
US Patents:0
Applicants:1
NDAs:1
Clinical Trials: 2
DailyMed Link:FINASTERIDE AND TADALAFIL at DailyMed
Drug patent expirations by year for FINASTERIDE AND TADALAFIL
Recent Clinical Trials for FINASTERIDE AND TADALAFIL

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

SponsorPhase
Vanderbilt University Medical CenterPhase 2
Eli Lilly and CompanyPhase 3

See all FINASTERIDE AND TADALAFIL clinical trials

US Patents and Regulatory Information for FINASTERIDE AND TADALAFIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Lifesciences FINASTERIDE AND TADALAFIL finasteride; tadalafil CAPSULE;ORAL 218232-001 Mar 15, 2024 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

FINASTERIDE AND TADALAFIL Market Analysis and Financial Projection Experimental

Finasteride and Tadalafil: Market Dynamics and Financial Trajectory

Introduction

Finasteride and tadalafil are two medications that have garnered significant attention in the pharmaceutical industry, particularly for their roles in treating benign prostatic hyperplasia (BPH), male pattern baldness, and erectile dysfunction (ED). This article delves into the market dynamics and financial trajectory of these drugs, highlighting key drivers, challenges, and future projections.

Market Size and Growth

The finasteride market is anticipated to experience steady growth over the coming years. As of 2023, the global finasteride market size was valued at approximately USD 109.5 million and is projected to reach USD 154.82 million by 2036, growing at a CAGR of around 2.7% during the forecast period[1][5].

Key Drivers of Growth

Increasing Prevalence of BPH and Hair Loss

The rising prevalence of BPH and male pattern baldness are significant drivers of the finasteride market. According to the Urology Care Foundation, about half of the men between the ages of 51 and 60 suffer from BPH, and this condition affects 90% of men above the age of 80[1].

Growing Geriatric Population

The increasing geriatric population globally is another key factor. As people age, the incidence of BPH and hair loss increases, thereby driving the demand for finasteride[1][3].

Consumer Spending on Hair Treatment

There is a growing emphasis on physical appearance, especially in emerging economies, leading to increased consumer spending on hair treatment products. This trend is expected to continue, fueling the demand for finasteride[1][3].

Online Pharmacy Segment Growth

The shift towards digital technology and the increasing number of online medical stores are driving the growth of the online pharmacy segment. This segment is anticipated to witness the highest growth by the end of 2030[1].

Role of Tadalafil in Market Dynamics

Combination Therapy with Finasteride

Studies have shown that the co-administration of tadalafil with finasteride can significantly improve symptoms of BPH and ED. A study by Lilly demonstrated that Cialis (tadalafil) co-administered with finasteride met the primary endpoint, improving International Prostate Symptom Score (IPSS) total scores and erectile function in men with lower urinary tract symptoms of BPH[2].

Licensing Agreements

Licensing agreements, such as the one between Sanofi and Lilly for Cialis, are also influencing the market. These agreements can expand the reach and availability of these medications, potentially increasing their market share[4].

Market Segmentation

Application

The finasteride market is segmented by application 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. The hair treatment segment is also expected to see notable growth due to the increasing incidence of alopecia among young adults[1].

Distribution Channel

On the basis of distribution channels, the online pharmacy segment is expected to witness the highest growth. However, retail pharmacies currently hold a substantial market revenue due to consumer trust and familiarity[1][5].

Geographical Analysis

The finasteride market is segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. The Asia Pacific region is set to hold the largest revenue share by 2036, driven by the growing penetration of finasteride in developing and under-developing countries[1].

Challenges and Impact of External Factors

COVID-19 Pandemic

The COVID-19 pandemic has had a significant impact on the global finasteride market, causing disruptions in production and supply chain activities. Restrictions on import-export have also affected the market[3].

Regulatory Approvals

Regulatory approvals and changes can significantly impact the market. For instance, the FDA's acceptance of the application for the use of tadalafil and finasteride as a combination capsule for BPH treatment is a positive development[1].

Financial Projections

Revenue Growth

The global finasteride market is expected to grow from USD 111.87 million in 2024 to USD 154.82 million by 2036, at a CAGR of 2.7%[1].

Regional Contributions

North America currently holds the largest share of the global market, but the Asia Pacific region is expected to drive significant growth in the future. India, in particular, is expected to offer lucrative growth opportunities due to its increasing geriatric population[1][3].

Key Players and Market Strategies

Market Players

Key players in the finasteride market include Accord Pharmaceuticals, Actavis, Cipla, Henan Topfond, Merck, and Mylan N.V. These companies are focusing on mergers and acquisitions, as well as the development of bio-pharmaceuticals, to gain a competitive edge[5].

Strategic Moves

Market players are also investing in research and development to create more effective treatments. For example, HanAll Biopharma reported significant sales of its 1 mg-based hair loss pills, finasteride, highlighting the potential for innovative products in the market[5].

Consumer Behavior and Preferences

Shift to Online Pharmacies

Consumers are increasingly shifting towards online pharmacies due to the convenience and accessibility offered by digital platforms. This trend is expected to continue, driving growth in the online pharmacy segment[1][5].

Focus on Physical Appearance

The growing emphasis on physical appearance, especially in Europe and other developed regions, is driving the demand for hair treatment products, including finasteride[3].

Regulatory Environment

FDA Approvals

Regulatory approvals, such as the FDA's acceptance of the combination capsule of tadalafil and finasteride, play a crucial role in shaping the market. These approvals can expand the treatment options available to patients and influence market growth[1].

Technological Advances

Telemedicine and E-commerce

The rise of telemedicine and e-commerce platforms is transforming how medications are prescribed and purchased. This shift is expected to continue, making finasteride more accessible to a wider audience[5].

Key Takeaways

  • The finasteride market is driven by the increasing prevalence of BPH and hair loss, as well as the growing geriatric population.
  • The co-administration of tadalafil with finasteride has shown promising results in treating BPH and ED.
  • The online pharmacy segment is expected to witness significant growth due to consumer shift towards digital technology.
  • Regulatory approvals and licensing agreements are crucial for market expansion.
  • Key players are focusing on mergers, acquisitions, and R&D to maintain market competitiveness.

FAQs

What are the primary applications of finasteride?

Finasteride is primarily used for the treatment of benign prostatic hyperplasia (BPH) and male pattern baldness.

How does the co-administration of tadalafil with finasteride impact BPH symptoms?

The co-administration of tadalafil with finasteride has been shown to significantly improve IPSS total scores and erectile function in men with lower urinary tract symptoms of BPH[2].

What is the projected growth rate of the finasteride market?

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

Which region is expected to hold the largest revenue share in the finasteride market by 2036?

The Asia Pacific region is set to hold the largest revenue share in the finasteride market by 2036[1].

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

The COVID-19 pandemic has caused disruptions in production and supply chain activities, significantly impacting the global finasteride market[3].

Sources

  1. Research Nester: Finasteride Market Size & Share, Growth Report 2036
  2. Lilly Investor: New Study of CialisĀ® (tadalafil) Tablets Co-administered with Finasteride
  3. BioSpace: Finasteride Market Will Expand as Demand for Effective Benign Prostate Hyperplasia Treatment Rises
  4. Lilly Investor: Sanofi and Lilly announce licensing agreement for CialisĀ® (tadalafil) OTC
  5. Polaris Market Research: Finasteride Market Statistics, Growth & Competitive Analysis 2032

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