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Last Updated: January 5, 2025

FLUCINOLONE ACETONIDE Drug Patent Profile


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Which patents cover Flucinolone Acetonide, and what generic alternatives are available?

Flucinolone Acetonide is a drug marketed by Glenmark Pharms Ltd and is included in one NDA.

The generic ingredient in FLUCINOLONE ACETONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Flucinolone Acetonide

A generic version of FLUCINOLONE ACETONIDE was approved as fluocinolone acetonide by TARO on April 27th, 1982.

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Drug patent expirations by year for FLUCINOLONE ACETONIDE
Recent Clinical Trials for FLUCINOLONE ACETONIDE

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

SponsorPhase
Samsung Medical CenterPhase 4
Asan Medical CenterPhase 4
Kyunghee University Medical CenterPhase 4

See all FLUCINOLONE ACETONIDE clinical trials

Pharmacology for FLUCINOLONE ACETONIDE

US Patents and Regulatory Information for FLUCINOLONE ACETONIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Pharms Ltd FLUCINOLONE ACETONIDE fluocinolone acetonide OIL;TOPICAL 210556-001 Oct 25, 2018 AT RX 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

FLUCINOLONE ACETONIDE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Fluocinolone Acetonide

Introduction to Fluocinolone Acetonide

Fluocinolone acetonide is a synthetic corticosteroid used in various medical applications, including dermatological conditions such as eczema, psoriasis, and dermatitis, as well as ophthalmic conditions like non-infectious posterior uveitis. The market for this pharmaceutical drug is experiencing significant growth, driven by several key factors.

Market Growth and Projections

The fluocinolone acetonide market is anticipated to maintain a robust growth trajectory from 2023 to 2031. This growth is supported by a compound annual growth rate (CAGR) of around 15.39%, with the market expected to transition from a valuation of USD 8.1 billion in 2024 to USD 22.04 billion by 2031[3].

Key Drivers of Market Growth

Rising Prevalence of Skin Disorders

The increasing incidence of skin disorders globally, exacerbated by factors such as pollution and stress, drives the demand for effective dermatological treatments like fluocinolone acetonide. This corticosteroid's efficacy in reducing inflammation and relieving itching makes it a preferred choice among healthcare providers and patients[3].

Advancements in Pharmaceutical Research

Ongoing research and development efforts focused on optimizing formulations and delivery methods contribute to market expansion. Improved formulations and delivery systems enhance treatment outcomes and patient compliance, further boosting the market[3].

Growing Aging Population and Urbanization

The growing aging population and increasing urbanization, particularly in regions like Asia-Pacific, lead to greater demand for fluocinolone acetonide products. Urban centers with heightened needs for specific treatments drive market growth[3].

Mergers and Acquisitions

The fluocinolone acetonide market is witnessing a wave of mergers and acquisitions as companies seek to consolidate their market positions, expand their product portfolios, and leverage synergies to drive growth and competitiveness. These strategic consolidations provide access to new technologies, intellectual property, and talent, enabling companies to innovate faster and stay ahead of market trends[3].

Regional Market Dynamics

North America

North America, particularly the United States and Canada, is a significant player in the global fluocinolone acetonide market. The region benefits from a robust economy, technological advancements, and a strong consumer base with high purchasing power[3].

Europe

Europe, comprising countries such as the United Kingdom, Germany, France, and Italy, is characterized by a mature market with well-established infrastructure and consumer preferences. This region continues to be a major contributor to the global market[3].

Asia-Pacific

The Asia-Pacific region, driven by countries like China, Japan, India, and South Korea, is experiencing rapid growth. The large population, rising disposable income, and increasing urbanization in this region lead to greater demand for fluocinolone acetonide products and services[3].

Latin America and Middle East & Africa

Latin America, with countries like Brazil, Mexico, and Argentina, presents opportunities and challenges due to economic fluctuations and political instability. The Middle East and Africa, including countries like UAE, Saudi Arabia, South Africa, and Nigeria, represent emerging markets with promising growth potential driven by economic diversification efforts, urbanization, and a young population[3].

Financial Performance and Commercial Activities

EyePoint Pharmaceuticals

EyePoint Pharmaceuticals, a key player in the ophthalmic segment, has reported significant financial and commercial progress. The company's products, such as YUTIQ (fluocinolone acetonide intravitreal implant) and DEXYCU, have seen strong customer order growth. For instance, YUTIQ has been included in more than 20 academic formularies and is pending inclusion in additional ones. The commercial launch of these products has been supported by a robust sales and marketing infrastructure, with over 400 physicians certified to purchase and administer DEXYCU[2][5].

Financial Outlook

Revenue and Operating Expenses

In the third quarter of 2019, EyePoint Pharmaceuticals reported total revenue of $2.5 million, with net product revenue primarily generated from sales of DEXYCU. Operating expenses increased to $16.6 million, driven by investments in sales and marketing infrastructure, professional services, and cost of sales related to product revenue. Despite a net loss of $15.6 million, the company's financial outlook remains positive due to the strong growth trajectory of its products[2].

Challenges and Opportunities

Regulatory Environment

The market is influenced by regulatory environments, particularly the approval and inclusion of products in formularies. For example, YUTIQ received a specific and permanent J Code, effective October 1, 2019, which facilitated its adoption in clinical settings[5].

Competitive Landscape

The competitive landscape is dynamic, with several key players such as Tianyao Pharma, Fonow, Farmabios, TEVA Pharmaceutical, and Pacificphar. Companies are engaging in strategic consolidations and research and development to maintain market competitiveness[3].

Key Takeaways

  • The fluocinolone acetonide market is expected to grow significantly from 2023 to 2031, driven by rising skin disorders, advancements in pharmaceutical research, and demographic changes.
  • North America, Europe, and Asia-Pacific are major regions contributing to the global market.
  • Companies like EyePoint Pharmaceuticals are experiencing strong commercial performance with their ophthalmic products.
  • The market is characterized by a positive financial outlook despite current operational expenses.
  • Regulatory approvals and strategic consolidations play crucial roles in market dynamics.

FAQs

  1. What are the primary applications of fluocinolone acetonide?

    • Fluocinolone acetonide is primarily used to treat dermatological conditions such as eczema, psoriasis, and dermatitis, as well as ophthalmic conditions like non-infectious posterior uveitis.
  2. Which regions are driving the growth of the fluocinolone acetonide market?

    • North America, Europe, and Asia-Pacific are the key regions driving the growth of the fluocinolone acetonide market.
  3. What are the key drivers of the fluocinolone acetonide market?

    • The key drivers include the rising prevalence of skin disorders, advancements in pharmaceutical research, growing aging population, urbanization, and strategic consolidations.
  4. Who are some of the major players in the fluocinolone acetonide market?

    • Major players include Tianyao Pharma, Fonow, Farmabios, TEVA Pharmaceutical, Pacificphar, and EyePoint Pharmaceuticals.
  5. What is the expected CAGR of the fluocinolone acetonide market from 2024 to 2031?

    • The fluocinolone acetonide market is expected to have a CAGR of around 15.39% from 2024 to 2031.

Sources

  1. Global Fluocinolone Acetonide Market Size, Trends and Projections - Market Research Intellect
  2. EyePoint Pharmaceuticals Reports Third Quarter 2019 Financial - EyePoint Pharmaceuticals
  3. Fluocinolone Acetonide Market Size, Share and Forecast By Key Players - OpenPR
  4. Fluocinolone Acetonide Cream Market Size, Scope And Forecast - Market Research Intellect
  5. EyePoint Pharmaceuticals Reports Second Quarter 2019 Financial - EyePoint Pharmaceuticals

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