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 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 Inc, 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.

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

Summary for FLUOCINOLONE ACETONIDE

International Patents:	185
US Patents:	3
Tradenames:	16
Applicants:	31
NDAs:	79
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	36
Patent Applications:	7,343
Drug Prices:	Drug price trends for FLUOCINOLONE ACETONIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
Chulalongkorn University	NA
Alimera Sciences	PHASE4
Eclipse Life Sciences, Inc.	PHASE1

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
Anda Repository	FLAC	fluocinolone acetonide	OIL/DROPS;OTIC	210736-001	Apr 11, 2018	AT	RX	No	No
Cosette	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	089526-001	Jul 26, 1988	AT	RX	No	No
Bausch And Lomb	RETISERT	fluocinolone acetonide	IMPLANT;INTRAVITREAL	021737-001	Apr 8, 2005		RX	Yes	Yes
Sun Pharma Canada	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	OIL;TOPICAL	202368-001	May 19, 2016	AT	RX	No	No
Pharmaderm	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	OINTMENT;TOPICAL	088046-001	Dec 16, 1982		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
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

International Patents for FLUOCINOLONE ACETONIDE

Country	Patent Number	Title	Estimated Expiration
Japan	2011093944	BIODEGRADABLE SUSTAINED RELEASE DRUG DELIVERY SYSTEM
Eurasian Patent Organization	004980	УСТРОЙСТВА ДЛЯ ДОСТАВКИ ЛЕКАРСТВ С ПРОЛОНГИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СПОСОБЫ ПРИМЕНЕНИЯ И СПОСОБЫ ИХ ИЗГОТОВЛЕНИЯ (SUSTAINED RELEASE DRUG DELIVERY DEVICES, METHODS OF USE AND METHODS OF MANUFACTURING THEREOF)
Spain	2315680
Brazil	0110243	Sistema de aplicação de droga de liberação prolongada, e, métodos para o tratamento de um organismo de mamìfero, para fornecer administração controlada e prolongada de um agente eficaz para se obter um efeito fisiológico ou farmacológico local ou sistêmico desejado, e de fabricação de um sistema de aplicação prolongada de droga
Malaysia	135804	PROCESSES OF FORMING A DRUG DELIVERY DEVICE

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

Market Dynamics and Financial Trajectory for Fluocinolone Acetonide

Last updated: July 27, 2025

Introduction

Fluocinolone acetonide, a synthetic corticosteroid with potent anti-inflammatory and immunosuppressive properties, is primarily utilized in the treatment of dermatological, ocular, and certain systemic inflammatory conditions. Its regulatory approval, patent protection, and commercialization strategies significantly influence market dynamics and financial prospects. This report analyzes current market drivers, competitive landscape, regulatory environment, and future financial trajectories of fluocinolone acetonide-related products.

Pharmacological Profile and Therapeutic Applications

Fluocinolone acetonide is available in various formulations, including topical ointments, intravitreal implants, and systemic preparations. Its high potency renders it effective in managing conditions such as eczema, psoriasis, and allergic dermatitis. In ophthalmology, intravitreal implants deliver sustained drug release, targeting chronic uveitis and diabetic macular edema.

This multifaceted usage broadens its market scope, yet the drug faces competition from other corticosteroids with similar efficacy. The drug's safety profile, characterized by risks of local and systemic side effects, influences prescribing patterns and market penetration.

Market Dynamics

1. Regulatory Environment and Approvals

Regulatory bodies globally, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regional agencies, govern fluocinolone acetonide’s approval and market presence. The most prominent product—ILUVIEN (fluocinolone acetonide intravitreal implant)—received FDA approval in 2014 for chronic diabetic macular edema in patients responsive to corticosteroids. Its approval marked a significant market entry, bolstering the product’s commercial trajectory.

Regulatory hurdles, such as the need for extensive clinical evidence on safety and efficacy, particularly for new formulations, impact product development timelines and launch strategies. Patent expirations and the potential for biosimilar or generic entrants pose additional challenges, impacting pricing and profit margins.

2. Patent Landscape and Market Exclusivity

The patent lifecycle significantly influences market exclusivity. ILUVIEN’s patent exclusivity protects it from generic competition until approximately 2024–2026, depending on jurisdiction. Once expired, price competition intensifies, leading to potential revenue declines unless robust pipeline or alternative formulations fill the void.

The landscape is further complicated by patent litigation and secondary patents designed to extend exclusivity. Companies are exploring innovative delivery mechanisms, such as biodegradable implants, to maintain competitive advantage.

3. Competition and Market Share

The corticosteroid market is crowded, with drugs like triamcinolone acetonide and dexamethasone competing across indications. In the ophthalmic segment, dexamethasone intravitreal implants (e.g., OZURDEX) challenge fluocinolone acetonide, especially given differing safety and efficacy profiles.

In dermatology, topical fluocinolone acetonide formulations face competition from other high-potency corticosteroids and emerging biologic options for inflammatory skin conditions, influencing market share dynamics.

4. Manufacturing and Supply Chain Considerations

Manufacturing partnerships, quality control, and supply chain robustness influence product availability and cost structure. As the patent landscape evolves, strategic manufacturing agreements can mitigate risks associated with generic competition and biosimilar entry.

5. Pricing and Reimbursement Policies

Pricing strategies are dictated by clinical value, competitive landscape, and payer policies. Healthcare systems worldwide increasingly emphasize cost-effectiveness, affecting formulary placement and reimbursement levels.

In ophthalmic indications, intravitreal implants’ high costs are justified by the potential for reduced treatment frequency, curbing overall healthcare expenditure—an attractive proposition for payers.

Financial Trajectory

1. Revenue Forecasts

Currently, fluocinolone acetonide’s revenue is predominantly driven by ILUVIEN, with sales exceeding $300 million annually (per recent industry data)[1]. The revenue plateau is anticipated approaching patent expiration, unless new formulations or indications gain approval.

Projection models suggest that, with patent expiration forecasted between 2024–2026, global revenue could decline by 20–40% absent new product launches or expanded indications.

2. Development Pipeline and Pipeline Products

Investments in novel delivery systems and extended-release implants are underway to sustain profitability. For example, REENOVA (a biodegradable fluocinolone acetonide implant) aims to address unmet needs in chronic inflammatory conditions with potentially longer-lasting effects and improved safety profiles.

Successful commercialization of such innovations can diversify revenue streams, extend product lifecycle, and justify R&D investments.

3. Market Entry of Biosimilars and Generics

Post-patent expirations, biosimilar entrants could significantly diminish pricing power and margins. Early market entry and strategic patent litigation are critical to delaying biosimilar penetration.

4. Strategic Collaborations and Licensing Opportunities

Partnerships with ophthalmic and dermatologic pharmaceutical companies facilitate market expansion, joint marketing, and co-development of new formulations, bolstering financial outlooks.

Regulatory and Market Challenges

• Safety Concerns: Ocular and systemic corticosteroid side effects (glaucoma, cataracts, systemic immunosuppression) necessitate cautious prescribing and monitoring, impacting market uptake.
• Indication Expansion Risks: Off-label use and regulatory restrictions pose risks of adverse publicity or legal issues.
• Competitive Pressure: Evolving therapies, including biologics and novel small molecules, threaten corticosteroid market share.

Opportunities for Growth

• New Indications: Extending approvals into conditions like psoriasis, allergic conjunctivitis, or non-infectious uveitis could expand revenue.
• Precision Medicine: Biomarker-driven patient selection can optimize efficacy and safety, encouraging formulary inclusion.
• Innovation in Delivery: Sustained-release and biodegradable implants offer competitive advantages, improving adherence and safety profiles.

Key Takeaways

• Patent cliffs threaten immediate revenue stability, necessitating strategic early-stage investments into pipeline products and formulations.
• Regulatory approval of innovative delivery systems represents critical growth opportunities, especially in ophthalmology.
• Market competition from biosimilars and generics demands proactive patent management and differentiated product offerings.
• Pricing strategies aligned with healthcare policy and real-world value proposition optimization will be decisive in maintaining market share.
• Investments in safety profile improvements and expanded indications can mitigate competitive pressures and foster long-term financial stability.

Conclusion

Fluocinolone acetonide’s market outlook hinges on its ability to navigate patent expirations, regulatory challenges, and evolving competition. While current revenues are substantial, future growth depends on innovation in formulations, expanding indications, and strategic collaborations. By aligning R&D with emerging clinical needs and market trends, stakeholders can secure a resilient financial trajectory.

---

FAQs

1. When will the patent for ILUVIEN expire, and how will that impact the market?
The primary patent is projected to expire around 2024–2026, opening the market to biosimilar and generic entries, likely reducing prices and revenue unless new formulations or indications are introduced.

2. Are there ongoing efforts to develop new formulations of fluocinolone acetonide?
Yes, companies are exploring biodegradable implants and sustained-release systems designed to extend treatment duration, improve safety, and differentiate their products in the market.

3. How does fluocinolone acetonide compare to other corticosteroids in terms of safety?
While effective, fluocinolone acetonide carries risks intrinsic to corticosteroids, such as glaucoma and cataracts in ophthalmic applications, or skin atrophy in dermatologic formulations. Safety profiles are comparable but require careful patient monitoring.

4. Which global regions offer the highest growth prospects for fluocinolone acetonide products?
Ophthalmology markets in North America and Europe dominate sales; however, emerging markets in Asia show increasing adoption, driven by rising prevalence of diabetic retinopathy and uveitis.

5. What are the main competitive threats for fluocinolone acetonide in the future?
The primary threats include biosimilar competition, alternative therapies such as biologics or newer small molecules, safety concerns impacting prescribing, and regulatory restrictions on long-term corticosteroid use.

---

Sources:

[1] Industry revenue reports, 2022.