fluocinolone acetonide - Profile

What are the generic sources for fluocinolone acetonide and what is the scope of freedom to operate?

Fluocinolone acetonide is the generic ingredient in sixteen branded drugs marketed by Alpharma Us Pharms, Allied, Cosette, Fougera Pharms Inc, Invatech, Perrigo New York, Pharmafair, Sun Pharma Canada, 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, Tp Anda Holdings, 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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for fluocinolone acetonide

International Patents:	185
US Patents:	3
Tradenames:	16
Applicants:	31
NDAs:	79
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
Alpharma Us Pharms	FLUOCET	fluocinolone acetonide	CREAM;TOPICAL	088360-001	Jan 16, 1984		DISCN	No	No
Allied	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	088047-001	Dec 16, 1982		DISCN	No	No
Alpharma Us Pharms	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	088361-001	Jan 16, 1984		DISCN	No	No
Cosette	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	089526-001	Jul 26, 1988	AT	RX	No	No
Cosette	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	089525-001	Jul 26, 1988		DISCN	No	No

Expired US Patents for fluocinolone acetonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alimera Sciences Inc	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014
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
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

International Patents for fluocinolone acetonide

Country	Patent Number	Title	Estimated Expiration
South Korea	20030009447	지속 방출 약물 전달 장치, 그의 사용 방법 및 그의 제조방법 (SUSTAINED RELEASE DRUG DELIVERY DEVICES METHODS OF USE AND METHODS OF MANUFACTURING THEREOF)
Canada	2545650	DISPOSITIFS D'ADMINISTRATION INJECTABLES A LIBERATION CONTINUE (INJECTABLE SUSTAINED RELEASE IMPLANT HAVING A BIOERODIBLE MATRIX CORE AND A BIOERODIBLE SKIN)
New Zealand	522002	Sustained release drug delivery devices
Japan	4619795
Australia	2003287666	SYSTEMIC DELIVERY OF ANTIVIRAL AGENTS

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

Investment Scenario and Fundamentals Analysis for Fluocinolone Acetonide

Last updated: February 19, 2026

What is Fluocinolone Acetonide?

Fluocinolone acetonide is a synthetic corticosteroid used in topical, intravitreal, and implant-based formulations to treat inflammatory and allergic conditions. It has multiple delivery forms, including eye drops, intravitreal injections, and implant devices for chronic eye diseases.

Market Overview and Therapeutic Applications

Therapeutic Indications

• Uveitis and other intraocular inflammatory conditions
• Allergic dermatitis
• Psoriasis
• Other skin inflammatory disorders

Key Product Forms

• Intravitreal implants (e.g., Iluvien for diabetic macular edema)
• Topical formulations
• Injectable solutions

Market Size and Growth

• Estimated global corticosteroid market (2022): $13 billion
• Expected CAGR (2022-2027): 4.5% (Source: MarketsandMarkets)
• Intravitreal corticosteroid segment (2022): ~$2 billion, with fluocinolone acetonide products representing significant shares due to chronic eye disease treatments

Patent and Regulatory Landscape

Patent Status

• Several patents expired or nearing expiration covering formulations and delivery devices
• Ongoing innovation in delivery systems, including sustained-release implants and biodegradable matrices

Regulatory Approvals

• Approved in US, EU, Japan, and emerging markets
• Approved indications mostly centered on ophthalmology (e.g., FDA approval for Iluvien in diabetic macular edema)
• Potential for expanded indications with ongoing clinical trials

Competitive Analysis

Main Competitors

• Dexamethasone (off-label and on-label uses)
• Corticosteroids in newer sustained-release formulations
• Biologic alternatives for inflammatory eye diseases

Differentiation Factors

• Established efficacy in ocular indications
• Long-acting implant formulations reducing treatment frequency
• Growing indications for implant technology

R&D and Pipeline Potential

Ongoing Clinical Trials

• New delivery systems for improved bioavailability
• Expanded indications, including non-ophthalmic inflammatory diseases
• Focus on biosimilars and combination therapies

Innovation Trends

• Biodegradable implants
• Injectable sustained-release formulations
• Gene therapy adjuncts

Cost and Pricing Dynamics

Pricing Models

• Range: $1,500 – $3,500 per implant (e.g., Iluvien)
• Reimbursement policies vary by country, impacting revenue

Cost Structure

• Manufacturing involves complex delivery device production
• R&D investments directed toward innovative delivery systems

Market Entry and Commercialization Risks

• Patent expirations may erode market share
• Regulatory hurdles for new indications
• Competition from biologics and alternative corticosteroids

Investment Outlook

Aspect	Data	Implication
Market size	~$2 billion (ophthalmology segment)	Stable, growing demand for intraocular corticosteroids
Patent status	Expiring or expired patents	Potential generic entry, revenue erosion
R&D pipeline	Ongoing innovation in delivery systems	Opportunities for niche market leadership
Regulatory environment	Established approvals, potential for expansions	Growth potential with approved new indications

Key Factors for Investment Decision

• Proven efficacy and established market presence in ophthalmic indications.
• Innovation in sustained-release delivery systems expanding therapeutic options.
• Patent expirations pose revenue risks; consider pipeline strengths for future growth.
• Competitive landscape shifting with biologic therapies in inflammatory diseases.

Key Takeaways

• Fluocinolone acetonide remains a significant corticosteroid in ophthalmology, especially for chronic conditions like diabetic macular edema.
• Growth prospects depend on innovation in delivery systems and approved indications.
• Patent expiration could lead to revenue decline unless offset by new formulations.
• R&D focuses on biodegradable implants and expanded indications, which could sustain or grow market share.
• Competitive environment intensifies with biologics and alternative therapies.

Frequently Asked Questions

1. What therapeutic areas does fluocinolone acetonide target?
Primarily ophthalmologic conditions like diabetic macular edema and uveitis, with potential expansion to other inflammatory diseases.

2. How does patent expiration impact market dynamics?
Patent expirations risk generic entry, leading to price erosion and market share loss. Companies must innovate or seek new indications for growth.

3. What are the key drivers of growth in the corticosteroid market?
Growing prevalence of chronic inflammatory diseases, technological advances in implant delivery, and expanded approved uses.

4. Are there biosimilars or generics available?
Some formulations are approaching patent expiry, increasing the likelihood of biosimilar and generic competition.

5. What is the outlook for R&D in fluocinolone acetonide formulations?
Focus is on biodegradable and sustained-release implants, with clinical trials exploring expanded therapeutic uses.

References

[1] MarketsandMarkets. (2022). Corticosteroids Market Report.
[2] U.S. Food and Drug Administration (FDA). (2022). Approved drugs for ophthalmic indications.
[3] European Medicines Agency (EMA). (2021). Marketing authorizations for corticosteroid formulations.
[4] IQVIA. (2022). Global ophthalmic drug market analysis.