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Last Updated: December 22, 2024

FLUOCINOLONE ACETONIDE Drug Patent Profile


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When do Fluocinolone Acetonide patents expire, and when can generic versions of Fluocinolone Acetonide launch?

Fluocinolone Acetonide is a drug marketed by Allied, Alpharma Us Pharms, Cosette, Fougera Pharms Inc, Invatech, Perrigo New York, Pharmafair, Taro, Usl Pharma, Amneal, Padagis Israel, Quagen, Rising, Sciegen Pharms Inc, Trupharma, Novel Labs Inc, Pharmaderm, Actavis Labs Ut Inc, Bausch And Lomb, Chartwell Rx, Encube Ethicals, Lupin, and Pai Holdings Pharm. and is included in fifty-five NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Fluocinolone Acetonide

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

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Summary for FLUOCINOLONE ACETONIDE
Drug patent expirations by year for FLUOCINOLONE ACETONIDE
Drug Prices for FLUOCINOLONE ACETONIDE

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Recent Clinical Trials for FLUOCINOLONE ACETONIDE

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

SponsorPhase
National Eye Institute (NEI)Phase 3
Jaeb Center for Health ResearchPhase 3
Genentech, Inc.Phase 3

See all FLUOCINOLONE ACETONIDE clinical trials

Pharmacology for FLUOCINOLONE ACETONIDE
Medical Subject Heading (MeSH) Categories for FLUOCINOLONE ACETONIDE

US Patents and Regulatory Information for FLUOCINOLONE ACETONIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmafair FLUOCINOLONE ACETONIDE fluocinolone acetonide OINTMENT;TOPICAL 088507-001 Feb 27, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Quagen FLUOCINOLONE ACETONIDE fluocinolone acetonide OIL;TOPICAL 212761-001 Apr 2, 2021 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cosette FLUOCINOLONE ACETONIDE fluocinolone acetonide SOLUTION;TOPICAL 207441-001 Sep 28, 2016 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Allied FLUOCINOLONE ACETONIDE fluocinolone acetonide SOLUTION;TOPICAL 088048-001 Dec 16, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Encube Ethicals FLUOCINOLONE ACETONIDE fluocinolone acetonide SOLUTION;TOPICAL 209913-001 Feb 13, 2019 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Taro FLUOCINOLONE ACETONIDE fluocinolone acetonide SOLUTION;TOPICAL 089124-001 Sep 11, 1985 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

FLUOCINOLONE ACETONIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Fluocinolone Acetonide

Introduction

Fluocinolone acetonide, a potent corticosteroid, has been gaining significant traction in the pharmaceutical market due to its efficacy in treating various dermatological and ophthalmological conditions. This article delves into the market dynamics, financial performance, and future prospects of fluocinolone acetonide.

Market Size and Growth Prospects

The fluocinolone acetonide market is anticipated to experience robust growth over the forecast period from 2023 to 2031. The market is projected to grow at a compound annual growth rate (CAGR) of 15.39%, transitioning from a valuation of USD 8.1 billion in 2024 to USD 22.04 billion by 2031[5].

Drivers of Market Growth

Several factors are driving the growth of the fluocinolone acetonide market:

Increasing Incidence of Skin Disorders

The rising incidence of skin disorders such as eczema, psoriasis, and dermatitis is a significant driver. Fluocinolone acetonide's efficacy in reducing inflammation and relieving itching makes it a preferred treatment option[5].

Ongoing Research and Development

Continuous research and development efforts aimed at optimizing formulations and delivery methods are contributing to market expansion. For instance, the development of intravitreal inserts like YUTIQ for treating uveitic macular edema has shown long-term durability and favorable safety profiles[2].

Urbanization and Demographic Changes

The increasing urban population, particularly in regions like Asia-Pacific, is propelling the demand for fluocinolone acetonide. Urban centers have a heightened need for specific treatments, driving market growth[5].

Market Segments and Applications

The fluocinolone acetonide market can be segmented into various applications:

Dermatological Conditions

Fluocinolone acetonide creams and ointments are widely used to treat dermatological conditions. The market for these products is growing due to their effectiveness in managing chronic skin ailments[5].

Ophthalmological Conditions

Intravitreal inserts like YUTIQ, developed by EyePoint Pharmaceuticals, are used to treat noninfectious posterior uveitis and uveitic macular edema. These products have shown significant promise and are contributing to the market's growth[2][4].

Key Players and Market Competition

The fluocinolone acetonide market is characterized by the presence of several key players:

EyePoint Pharmaceuticals

EyePoint Pharmaceuticals is a significant player, especially with its product YUTIQ, which has received specific and permanent J Code approval. The company has seen increased revenue from the commercial launches of YUTIQ and DEXYCU[4].

Other Key Players

Other notable players include Tianyao Pharma, Fonow, Farmabios, TEVA Pharmaceutical, and Pacificphar. These companies are involved in various mergers and acquisitions to consolidate their market positions and expand their product portfolios[5].

Financial Performance of Key Players

EyePoint Pharmaceuticals, a key player in the ophthalmological segment, has reported significant financial activities:

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 and program costs[2].

Cash and Cash Equivalents

As of September 30, 2019, the company had $31.8 million in cash and cash equivalents, down from $44.2 million at June 30, 2019. This reflects the company's ongoing investments in product launches and marketing efforts[2].

Regional Market Analysis

The fluocinolone acetonide market is geographically diverse, with several regions contributing to its growth:

North America

North America, particularly the United States and Canada, is a significant market due to its robust economy, technological advancements, and strong consumer base[5].

Europe

Europe, including countries like the UK, Germany, France, and Italy, has a mature market with well-established infrastructure and consumer preferences[5].

Asia-Pacific

The Asia-Pacific region, driven by countries like China, Japan, India, and South Korea, is rapidly growing due to a large population, rising disposable income, and increasing urbanization[5].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa represent emerging markets with promising growth potential, driven by economic diversification efforts, urbanization, and a young population[5].

Challenges and Opportunities

Despite the positive growth trajectory, the fluocinolone acetonide market faces several challenges and opportunities:

Regulatory Environment

Stringent regulations and the need for sustainable alternatives can impact market dynamics. However, these challenges also present opportunities for companies to innovate and develop eco-friendly products[5].

Mergers and Acquisitions

The market is witnessing a wave of mergers and acquisitions as companies seek to consolidate their positions, expand product portfolios, and leverage synergies to drive growth and competitiveness[5].

Future Outlook

The future outlook for the fluocinolone acetonide market is promising, driven by:

Increasing Demand

The rising demand for effective treatments for skin and eye disorders will continue to drive market growth.

Technological Advancements

Ongoing research and development will lead to the introduction of new and improved formulations, further boosting the market.

Expanding Geographic Reach

The market is expected to expand in emerging regions, driven by urbanization and increasing disposable income.

Key Takeaways

  • The fluocinolone acetonide market is projected to grow at a CAGR of 15.39% from 2024 to 2031.
  • The market is driven by the increasing incidence of skin and eye disorders, ongoing research and development, and demographic changes.
  • Key players like EyePoint Pharmaceuticals are contributing significantly to the market's growth through innovative products.
  • The market faces challenges such as regulatory environments but also presents opportunities for sustainable and innovative solutions.

FAQs

  1. What is the projected CAGR for the fluocinolone acetonide market from 2024 to 2031?

    • The fluocinolone acetonide market is anticipated to witness a CAGR of 15.39% from 2024 to 2031[5].
  2. Which regions are significant contributors to the fluocinolone acetonide market?

    • North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa are significant contributors to the market[5].
  3. What are the primary applications of fluocinolone acetonide?

    • Fluocinolone acetonide is primarily used to treat dermatological conditions like eczema, psoriasis, and dermatitis, as well as ophthalmological conditions such as noninfectious posterior uveitis and uveitic macular edema[2][5].
  4. Who are some of the key players in the fluocinolone acetonide market?

    • Key players include EyePoint Pharmaceuticals, Tianyao Pharma, Fonow, Farmabios, TEVA Pharmaceutical, and Pacificphar[5].
  5. What are the main drivers of the fluocinolone acetonide market?

    • The main drivers include the increasing incidence of skin and eye disorders, ongoing research and development, and demographic changes such as urbanization[5].

Sources

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

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