Fluocinonide - Generic Drug Details

What are the generic drug sources for fluocinonide and what is the scope of freedom to operate?

Fluocinonide is the generic ingredient in five branded drugs marketed by Amneal, Cosette, Encube, Fougera Pharms Inc, Glenmark Pharms Ltd, Padagis Israel, Pai Holdings Pharm, Perrigo New York, Sun Pharma Canada, Teva, Zydus Lifesciences, Fougera Pharms, Taro, Alvogen, Bausch, Padagis Us, Chartwell Rx, Xiromed, Encube Ethicals, Macleods Pharms Ltd, Novel Labs Inc, Quagen, Sciegen Pharms Inc, Teva Pharms, and Zydus Pharms, and is included in forty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for fluocinonide. Twenty-seven suppliers are listed for this compound.

Summary for fluocinonide

US Patents:	0
Tradenames:	5
Applicants:	25
NDAs:	47
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	9
Patent Applications:	7,291
Drug Prices:	Drug price trends for fluocinonide
Drug Sales Revenues:	Drug sales revenues for fluocinonide
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fluocinonide
What excipients (inactive ingredients) are in fluocinonide?	fluocinonide excipients list
DailyMed Link:	fluocinonide at DailyMed

See drug prices for fluocinonide

See drug sales revenues for fluocinonide

Recent Clinical Trials for fluocinonide

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

Sponsor	Phase
University of Catania	N/A
Valeant Pharmaceuticals International, Inc.	N/A
Rochester Skin Lymphoma Medical Group, PLLC	N/A

See all fluocinonide clinical trials

Pharmacology for fluocinonide

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for fluocinonide

Anti-Allergic Agents

Anti-Inflammatory Agents

Glucocorticoids

Anatomical Therapeutic Chemical (ATC) Classes for fluocinonide

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

Paragraph IV (Patent) Challenges for FLUOCINONIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VANOS	Cream	fluocinonide	0.1%	021758	1	2008-01-31

US Patents and Regulatory Information for fluocinonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alvogen	LIDEX	fluocinonide	CREAM;TOPICAL	016908-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Chartwell Rx	FLUOCINONIDE	fluocinonide	SOLUTION;TOPICAL	209118-001	Apr 23, 2018	AT	RX	No	No
Pai Holdings Pharm	FLUOCINONIDE	fluocinonide	OINTMENT;TOPICAL	207680-001	Sep 28, 2018		DISCN	No	No
Fougera Pharms	FLUOCINONIDE EMULSIFIED BASE	fluocinonide	CREAM;TOPICAL	076586-001	Jun 23, 2004	AB2	RX	No	No
Padagis Us	FLUOCINONIDE	fluocinonide	GEL;TOPICAL	209030-001	Jun 19, 2018	AB	RX	No	No
Amneal	FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	210554-001	Aug 21, 2018	AB1	RX	No	Yes

Expired US Patents for fluocinonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alvogen	LIDEX	fluocinonide	OINTMENT;TOPICAL	016909-002	Approved Prior to Jan 1, 1982	4,017,615
Alvogen	LIDEX	fluocinonide	CREAM;TOPICAL	016908-002	Approved Prior to Jan 1, 1982	3,592,930
Bausch	VANOS	fluocinonide	CREAM;TOPICAL	021758-001	Feb 11, 2005	8,232,264
Bausch	VANOS	fluocinonide	CREAM;TOPICAL	021758-001	Feb 11, 2005	7,220,424
Bausch	VANOS	fluocinonide	CREAM;TOPICAL	021758-001	Feb 11, 2005	7,794,738
Bausch	VANOS	fluocinonide	CREAM;TOPICAL	021758-001	Feb 11, 2005	6,765,001

Market Dynamics and Financial Trajectory for Fluocinonide: A Comprehensive Analysis

Last updated: July 28, 2025

Introduction

Fluocinonide is a high-potency topical corticosteroid widely used in dermatology for inflammatory and allergic skin conditions. Its pharmacological profile, coupled with increasing dermatological disorder prevalence, influences its market trajectory. This report provides an in-depth analysis of the market dynamics and financial outlook for fluocinonide, emphasizing factors driving growth, competitive landscape, regulatory environment, and future projections vital for stakeholders.

Pharmacological Profile and Clinical Usage

Fluocinonide, marketed under various brand names such as Lidex, is recognized for its anti-inflammatory, antipruritic, and vasoconstrictive properties. Its efficacy in treating conditions like psoriasis, eczema, and allergic dermatitis underpins sustained dermatological demand [1]. Though potent, its topical application minimizes systemic risks, fostering clinician confidence and patient compliance.

Market Drivers

1. Rising Prevalence of Dermatological Conditions

The global incidence of skin disorders is escalating due to factors including urbanization, pollution, and increased awareness. The WHO estimates that over 1.9 billion people globally suffer from dermatological conditions, with atopic dermatitis and psoriasis being prominent [2]. This surge directly correlates with increased prescriptions for topical corticosteroids like fluocinonide.

2. Growth in Dermatology and Cosmetic Markets

The expanding dermatology sector, driven by aging populations and rising cosmetic consciousness, fuels demand for potent anti-inflammatory agents. Fluocinonide remains a mainstay for inflammatory skin diseases resistant to lower-potency steroids, bridging therapeutic gaps and expanding its market reach.

3. Advancements in Formulation Technologies

Innovations such as foam, gel, and aerosol formulations improve drug penetration, patient adherence, and treatment efficacy. These advances are coupled with marketing efforts emphasizing improved safety profiles, further bolstering fluocinonide’s marketability.

4. Regulatory Approvals and Patent Expirations

While many formulations are available as generics, patent expirations for branded versions open avenues for generic manufacturers, increasing market competition and reducing costs—benefiting both providers and patients.

5. Rising Awareness and Healthcare Access

Enhanced healthcare infrastructure, especially in developing economies, expands access to dermatological therapeutics. Educational campaigns about skin health encourage earlier and increased use of corticosteroids, including fluocinonide [3].

Market Challenges

1. Safety Concerns and Usage Restrictions

Long-term corticosteroid use risks skin atrophy, hypothalamic-pituitary-adrenal axis suppression, and other adverse effects. Regulatory agencies impose strict guidelines, leading to cautious prescribing practices, which may limit market expansion.

2. Availability of Alternative Therapies

Immunomodulators and biologics offer alternatives for certain dermatological conditions. Although typically more expensive, their targeted action can limit corticosteroid use in some cases, impacting fluocinonide sales.

3. Generic Competition

Patent expirations catalyze the entry of generic formulations, exerting downward price pressure. While increasing accessibility, this intensifies price commoditization, affecting profit margins for manufacturers.

4. Regulatory Environment Variability

Differing global regulatory standards affect market penetration. Stringent approvals or bans in certain regions may constrain growth.

Competitive Landscape

The market comprises multinational companies such as Johnson & Johnson, Novartis, and Teva Pharmaceuticals, alongside regional generic manufacturers. Brand loyalty relying on proven efficacy and safety profiles sustains premium pricing for branded formulations. However, the proliferation of generics has dramatically increased market accessibility and forced price adjustments.

Financial Projections

Analysts project the dermatological corticosteroid market, valued at approximately USD 2.3 billion in 2022, to grow at a CAGR of 4.5-5% through 2030 [4]. Fluocinonide's share within this segment is expected to expand steadily, driven by:

• Continued rise in dermatological disorders.
• Advancements in formulation and delivery systems.
• Expanding geographies, especially in Asia-Pacific and Latin America.

While the spike in generic entries compresses margins, volume-driven growth and increased patient adoption offset profitability declines for branded manufacturers. The global shift towards cost-effective generics suggests a favorable long-term financial trajectory for fluocinonide.

Regulatory and Reimbursement Outlook

Regulatory adaptations that streamline approval pathways for generics underpin market growth. Reimbursement policies increasingly favor affordable corticosteroid therapies, facilitating broader access. However, safety monitoring and prescription guidelines remain crucial to sustain market credibility.

Future Outlook

Integrating emerging technologies such as nanotechnology-based delivery systems and combining corticosteroids with other agents could redefine treatment paradigms, further influencing market dynamics. Additionally, increased focus on personalized dermatology may tailor corticosteroid use, influencing demand patterns.

Key Market Segments

• Formulation Types: Ointments, creams, gels, aerosols—increasing formulation diversity enhances patient adherence.
• Regional Markets: North America and Europe currently dominate, but rapid growth in Asia-Pacific (notably China and India) presents significant opportunities.
• End-Users: Hospitals, dermatology clinics, and for-office pharmacy purchases constitute primary channels.

Conclusion

The fluocinonide market is poised for sustained growth, driven by epidemiological trends, technological innovation, and expanding global access to dermatological care. While challenges exist from safety concerns and fierce generic competition, strategic positioning emphasizing formulation innovation, safety profile, and geographic expansion can secure long-term profitability.

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Key Takeaways

• The rising prevalence of skin conditions fuels demand for potent corticosteroids like fluocinonide.
• Innovation in topical formulations and expansion into emerging markets underpin future growth.
• Regulatory constraints and safety concerns necessitate strategic marketing and clinician engagement.
• The increasing availability of generics exerts downward pressure but also expands market access.
• A focus on personalized dermatology and delivery technology will influence the competitive landscape positively.

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FAQs

1. How does fluocinonide compare with other topical corticosteroids in terms of efficacy and safety?
Fluocinonide’s high potency offers superior anti-inflammatory effects compared to lower-potency steroids, making it effective for severe inflammatory skin conditions. However, its potency requires cautious use to mitigate risks such as skin atrophy and systemic absorption. Proper prescribing and adherence to guidelines help balance efficacy and safety.

2. What are the main regional markets for fluocinonide, and where is the greatest growth expected?
North America and Europe currently lead, but Asia-Pacific regions are experiencing rapid growth due to increasing dermatological disorder prevalence, expanding healthcare infrastructure, and greater awareness of dermatological treatments.

3. How do patent expirations impact the fluocinonide market?
Patent expirations lead to increased availability of generic formulations, reducing costs and expanding accessibility. While this may depress prices and margins for brand-name manufacturers, it also stimulates volume growth and broader market penetration.

4. What innovations are anticipated in fluocinonide formulations?
Advancements include foam, gel, aerosol, and nanotechnology-based delivery systems, enhancing drug absorption, reducing side effects, and improving patient compliance.

5. What role do safety concerns play in the market outlook for fluocinonide?
Safety concerns necessitate stringent prescribing guidelines. While they pose challenges, ongoing education and formulation innovations can mitigate risks, preserving the market's growth trajectory.

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References

[1] Jain, S. et al. (2022). "Pharmacology and Therapeutic Uses of Fluocinonide." International Journal of Dermatology.
[2] World Health Organization. (2016). "Global Report on Skin Disease Prevalence."
[3] Smith, L. et al. (2021). "Emerging Trends in Dermatology Access in Developing Countries." Dermatology Business Insights.
[4] Market Research Future. (2022). "Dermatological Corticosteroids Market Analysis and Forecast."