FLUOCINOLONE ACETONIDE - Generic Drug Details

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

Fluocinolone acetonide is the generic ingredient in seventeen branded drugs marketed by Alpharma Us Pharms, Allied, Cosette, Fougera Pharms Inc, Invatech, Perrigo New York, Pharmafair, Taro, Usl Pharma, Allergan Herbert, Savage Labs, Medimetriks Pharms, Alimera Sciences Inc, Bausch And Lomb, Hill Dermac, Anda Repository, Amneal, Padagis Israel, Quagen, Rising, Sciegen Pharms Inc, Trupharma, Glenmark Pharms Ltd, Novel Labs Inc, Pharmaderm, Galderma Labs Lp, Actavis Labs Ut Inc, Chartwell Rx, Encube Ethicals, Lupin, and Pai Holdings Pharm, and is included in seventy-nine NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluocinolone acetonide has one hundred and seventy-seven patent family members in twenty-seven countries.

There are eleven drug master file entries for fluocinolone acetonide. Twenty-three suppliers are listed for this compound.

Summary for FLUOCINOLONE ACETONIDE

International Patents:	177
US Patents:	2
Tradenames:	17
Applicants:	31
NDAs:	79
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	33
Patent Applications:	6,820
Drug Prices:	Drug price trends for FLUOCINOLONE ACETONIDE
What excipients (inactive ingredients) are in FLUOCINOLONE ACETONIDE?	FLUOCINOLONE ACETONIDE excipients list
DailyMed Link:	FLUOCINOLONE ACETONIDE at DailyMed

See drug prices for FLUOCINOLONE ACETONIDE

Recent Clinical Trials for FLUOCINOLONE ACETONIDE

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

Sponsor	Phase
Jaeb Center for Health Research	Phase 3
Genentech, Inc.	Phase 3
National Institutes of Health (NIH)	Phase 3

See all FLUOCINOLONE ACETONIDE clinical trials

Pharmacology for FLUOCINOLONE ACETONIDE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for FLUOCINOLONE ACETONIDE

Anti-Inflammatory Agents

Glucocorticoids

Anatomical Therapeutic Chemical (ATC) Classes for FLUOCINOLONE ACETONIDE

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

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
Taro	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	087102-001	Apr 27, 1982		DISCN	No	No
Bausch And Lomb	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	SOLUTION;TOPICAL	040059-001	Dec 20, 1993		DISCN	No	No
Savage Labs	FLUOTREX	fluocinolone acetonide	OINTMENT;TOPICAL	088172-001	Mar 9, 1983		DISCN	No	No

Expired US Patents for FLUOCINOLONE ACETONIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alimera Sciences Inc	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018
Alimera Sciences Inc	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018
Bausch And Lomb	RETISERT	fluocinolone acetonide	IMPLANT;INTRAVITREAL	021737-001	Apr 8, 2005

International Patents for FLUOCINOLONE ACETONIDE

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1148931	具有可生物侵蝕基質芯和可生物侵蝕皮的注射用緩釋植入劑 (INJECTABLE SUSTAINED RELEASE IMPLANT HAVING A BIOERODIBLE MATRIX CORE AND A BIOERODIBLE SKIN)
Poland	1635875
Australia	2001253675

Supplementary Protection Certificates for FLUOCINOLONE ACETONIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2233112	122014000063	Germany		PRODUCT NAME: FLUOCINOLONACETONID; NAT. REGISTRATION NO/DATE: 82809.00.00 20120720; FIRST REGISTRATION: GB PL 27813/0001 20120504
2233112	132014902285293	Italy		PRODUCT NAME: FLUOCINOLONE ACETONIDE(ILUVIEN); AUTHORISATION NUMBER(S) AND DATE(S): 042616019, 20140530;PL27813/0001, 20120504

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