FLUOCINOLONE ACETONIDE Drug Patent Profile

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, Sun Pharma Canada, Usl Pharma, Amneal, Padagis Israel, Quagen, Rising, Sciegen Pharms, Tp Anda Holdings, Glenmark Pharms Ltd, 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-six NDAs.

The generic ingredient in FLUOCINOLONE ACETONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Nineteen 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 FOUGERA PHARMS INC on December 16^th, 1982.

Summary for FLUOCINOLONE ACETONIDE

US Patents:	0
Applicants:	24
NDAs:	56
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	37
Patent Applications:	4,782
Drug Prices:	Drug price information 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
Jinnah Postgraduate Medical Centre	NA
Alimera Sciences	PHASE4

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
Pharmaderm	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	OINTMENT;TOPICAL	088046-001	Dec 16, 1982		DISCN	No	No
Quagen	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	OIL;TOPICAL	212760-001	Apr 2, 2021	AT	RX	No	No
Chartwell Rx	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	SOLUTION;TOPICAL	209596-001	Dec 26, 2017	AT	RX	No	No
Actavis Labs Ut Inc	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	SOLUTION;TOPICAL	208386-001	Oct 21, 2016		DISCN	No	No
Cosette	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	SOLUTION;TOPICAL	207441-001	Sep 28, 2016		DISCN	No	No

Last updated: February 12, 2026

What Are the Current Market Dynamics for Fluocinolone Acetonide?

Fluocinolone acetonide is a potent topical corticosteroid used primarily in dermatology to treat inflammatory skin conditions such as eczema, psoriasis, and dermatitis. It is available in various formulations, including creams, oils, and intravitreal implants, which broaden its clinical applications.

Healthcare providers increasingly utilize fluocinolone acetonide due to its efficacy and relatively favorable safety profile for short-term use. However, the demand is constrained primarily by safety concerns related to long-term steroid exposure, such as skin atrophy, systemic absorption, and hypothalamic-pituitary-adrenal (HPA) axis suppression.

The drug's market environment is characterized by a competitive landscape with several generic formulations and branded products. Regulatory efforts to limit corticosteroid overuse have influenced prescribing behaviors, notably in pediatric populations. Generic competition has driven down prices, intensifying pressure on the profitability of branded formulations.

Global market share remains concentrated in North America and Europe, accounting for approximately 60% of the demand, owing to higher prevalence of dermatological conditions and broader access to dermatology services. Emerging markets in Asia-Pacific, Latin America, and the Middle East are experiencing growth driven by urbanization, increasing healthcare infrastructure, and rising awareness of skin conditions.

How Has the Financial Trajectory Evolved?

The historical financial performance of fluocinolone acetonide products reflects overall trends in corticosteroid markets. In 2022, the global dermatology corticosteroids market was valued at approximately USD 4.4 billion, with fluocinolone acetonide constituting a significant segment due to its widespread use.

Many formulations are off-patent, leading to a dominance of generics. The revenue pool for fluocinolone acetonide creams and ointments globally was estimated at roughly USD 600 million in 2022, with the intravitreal implant segment adding approximately USD 150 million. Growth rates for the overall corticosteroid market hover around 3-4% annually, with certain segments like intravitreal implants experiencing higher single-digit growth.

Branded formulations, such as that manufactured by Alcon in its intravitreal implant form, command premium pricing but face revenue pressures from patent expirations and generic competition. The intravitreal form, approved for diabetic macular edema, generated around USD 90 million in 2022, with analysts projecting a compound annual growth rate (CAGR) of approximately 5% over the next five years due to increasing indications and technological advances.

Research and development expenses are focused on new delivery mechanisms and expanding indications, which could influence future revenue streams. For example, injectable sustained-release formulations aim to improve adherence and safety profiles, potentially expanding market scope.

What Are the Key Market Drivers and Barriers?

Drivers:

• Increasing prevalence of dermatological conditions globally.
• Growing adoption of intravitreal fluocinolone acetonide implants for eye diseases like diabetic macular edema.
• Advances in drug delivery technologies enhancing efficacy and safety.
• Expansion into emerging markets with rising healthcare access.

Barriers:

• Safety concerns about long-term corticosteroid use.
• Stringent regulatory restrictions to mitigate adverse effects.
• Competition from non-steroidal anti-inflammatory drugs (NSAIDs) and biologics in certain indications.
• Price erosion from generic entries and market saturation.

What Are the Regulatory and Competitive Outlooks?

Regulatory agencies emphasize safety and efficacy, influencing formulation approvals and usage guidelines. For instance, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) enforce restrictions on high-dose formulations and recommend cautious long-term prescribing.

Competition stems from several generic producers, with market entry barriers lower due to the drug's age and patent expiry. Innovator companies are investing in drug delivery systems—e.g., biodegradable intravitreal implants, to differentiate their products and maintain market share.

The pipeline includes potential new indications and formulations. For example, trials for fluocinolone acetonide in uveitis and other inflammatory conditions suggest future revenue expansion if approved.

How Do Market Size and Growth Prospects Compare?

Segment	Market Size (2022)	CAGR (Next 5 Years)	Notes
Topical formulations	USD 600 million	2-4%	Dominant segment globally
Intravitreal implants	USD 150 million	approx. 5%	Rapid growth driven by emerging indications

Emerging markets are expected to drive future growth, with projected compound growth rates of 6-8% due to increasing healthcare infrastructure and disease burden.

What Are the Key Takeaways?

• Fluocinolone acetonide operates in a competitive landscape with stagnant growth in topical formulations but expanding opportunities in intravitreal delivery.
• The global market was valued at USD 750 million in 2022, with steady growth driven by technological innovation and expanding indications.
• Regulatory restrictions and safety concerns limit long-term and pediatric use, tempering revenue trajectories.
• Patent expiries have shifted revenues from branded to generic products, leading to price erosion.
• Future growth hinges on approval of new indications, improved delivery systems, and expansion into emerging markets.

FAQs

1. What are the main clinical uses of fluocinolone acetonide?
Treats inflammatory skin conditions (eczema, psoriasis) and certain eye diseases when formulated as intravitreal implants.

2. How does patent status affect the market?
Patent expirations have enabled generic competition, reducing prices and profit margins for branded products.

3. What are the safety concerns associated with fluocinolone acetonide?
Prolonged use can cause skin atrophy, systemic absorption leading to HPA axis suppression, and increased infection risk.

4. Which regions present the most growth opportunities?
Emerging markets in Asia-Pacific, Latin America, and the Middle East show expanding demand driven by urbanization and healthcare access.

5. What is the outlook for future formulations?
Long-acting implants and novel delivery systems likely will sustain growth, especially with approvals expanding beyond dermatology into ophthalmology.

Citations

1. MarketsandMarkets. "Corticosteroids Market," 2023.
2. GlobalData. "Dermatology Drugs Forecast," 2022.
3. U.S. FDA. "Regulatory Guidance on Corticosteroids," 2021.
4. ReportLinker. "Intravitreal Implants Market," 2022.
5. Statista. "Global Dermatology Market Size," 2022.