FLUOCINONIDE - Generic Drug Details

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

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, Taro, Teva, Zydus Lifesciences, Fougera Pharms, Alvogen, Bausch, Padagis Us, Chartwell Rx, Xiromed, Encube Ethicals, Macleods Pharms Ltd, Novel Labs Inc, Teva Pharms, and Zydus Pharms, and is included in forty-six NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for FLUOCINONIDE

US Patents:	0
Tradenames:	5
Applicants:	22
NDAs:	46
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	9
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
Zydus Lifesciences	FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	208989-001	Feb 10, 2020	AB	RX	No	No
Teva	FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	072488-001	Feb 6, 1989	AB1	RX	No	No
Encube	FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	211410-001	Oct 16, 2018		DISCN	No	No
Alvogen	LIDEX-E	fluocinonide	CREAM;TOPICAL	016908-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for FLUOCINONIDE

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

FLUOCINONIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluocinonide

Introduction to Fluocinonide

Fluocinonide is a topical corticosteroid used to treat various skin conditions, including redness, itching, swelling, and other discomforts associated with dermatological disorders. It is available in several formulations such as creams, gels, ointments, emollient creams, and solutions, all of which require a doctor's prescription[2].

Market Overview of Topical Corticosteroids

The global market for topical corticosteroids, which includes fluocinonide, has been experiencing significant growth. In 2023, the market was valued at USD 4,270.71 million and is projected to reach USD 6,102.07 million by 2030, growing at a Compounded Annual Growth Rate (CAGR) of 5.2%[3].

Drivers of Market Growth

Several factors are driving the growth of the topical corticosteroids market, including:

Rising Prevalence of Dermatological Conditions

The increasing incidence of skin conditions such as eczema, psoriasis, and dermatitis is a major driver. These conditions require effective treatments, and topical corticosteroids like fluocinonide are essential in managing these disorders[3].

Growing Geriatric Population

The elderly population is more prone to skin-related issues, which has further fueled the demand for topical corticosteroids. As the global population ages, the need for these medications is expected to increase[3].

Technological Advancements

Advancements in drug formulations have led to the development of more effective and safer topical corticosteroids. This has enhanced therapeutic outcomes and improved patient compliance[3].

Expanding Product Availability

The availability of these products across different regions, supported by robust marketing campaigns and improved healthcare infrastructure, is also driving market growth[3].

Market Segmentation

The global topical corticosteroids market, including fluocinonide, is segmented based on several criteria:

Type of Formulation

Fluocinonide is available in various formulations such as creams, gels, ointments, emollient creams, and solutions. Each formulation has its own market segment and user base[2].

Type of Potency Class

Topical corticosteroids are classified into different potency classes, ranging from low to very high potency. Fluocinonide falls into the high-potency category, which is often prescribed for severe skin conditions[3].

Type of Treatment

The market is also segmented based on the type of treatment, including prescription and over-the-counter (OTC) formulations. Fluocinonide is typically prescribed by a doctor due to its potency and potential side effects[2].

End User

The end-user segment includes hospitals, clinics, and retail pharmacies. The increasing availability of these products in retail pharmacies and online platforms has expanded their reach[3].

Financial Trajectory

Current Market Value

The global fluocinonide API market is part of the broader topical corticosteroids market, which was valued at USD 4,270.71 million in 2023. This market is expected to grow significantly over the next few years[3].

Projected Growth

By 2030, the global topical corticosteroids market is projected to reach USD 6,102.07 million. This growth is driven by the increasing demand for effective treatments for dermatological conditions and the expanding product availability across different regions[3].

Revenue Dynamics

The revenue growth in the fluocinonide market is influenced by factors such as the rising prevalence of skin conditions, technological advancements in drug formulations, and the growing geriatric population. These factors contribute to a steady increase in sales and revenue for fluocinonide and other topical corticosteroids[3].

Challenges and Restraints

Despite the positive growth trajectory, the market faces several challenges:

Side Effects

Prolonged use of corticosteroids like fluocinonide can lead to side effects such as skin thinning, hormonal imbalances, and other systemic issues. These concerns can limit the long-term use of these medications[3].

Regulatory Policies

Strict regulatory policies govern the use and distribution of topical corticosteroids. These regulations can sometimes act as barriers to market growth by imposing stringent approval processes and safety standards[3].

High Treatment Costs

The cost of treatment with topical corticosteroids, especially high-potency ones like fluocinonide, can be a significant restraint. High costs may limit access to these medications, particularly in emerging markets[3].

Opportunities for Growth

Emerging Markets

Emerging markets in Asia and Latin America offer significant potential due to increasing disposable incomes and growing awareness about dermatological treatments. The rise of online pharmacies and advancements in telemedicine are making these treatments more accessible[3].

Innovative Products

Pharmaceutical companies are investing in research and development to introduce innovative products with minimal side effects. This focus on innovation is expected to attract a larger customer base and drive market growth[3].

Key Takeaways

• The global topical corticosteroids market, including fluocinonide, is experiencing significant growth driven by the rising prevalence of dermatological conditions and technological advancements.
• The market is segmented based on formulation types, potency classes, types of treatment, and end-user demographics.
• Despite challenges such as side effects and regulatory policies, the market presents numerous opportunities for growth, particularly in emerging markets.
• The financial trajectory indicates a steady increase in revenue, with the market projected to reach USD 6,102.07 million by 2030.

FAQs

Q: What is fluocinonide used for?

Fluocinonide is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. It is a corticosteroid (cortisone-like medicine or steroid)[2].

Q: What are the common side effects of fluocinonide?

Common side effects include blistering, burning, crusting, dryness, or flaking of the skin, as well as thinning of the skin with easy bruising, especially when used on the face or where the skin folds together[2].

Q: Is fluocinonide available over-the-counter?

No, fluocinonide is available only with a doctor's prescription due to its potency and potential side effects[2].

Q: What is the projected growth rate of the global topical corticosteroids market?

The global topical corticosteroids market is expected to grow at a CAGR of 5.2% from 2023 to 2030[3].

Q: What are the main drivers of the global topical corticosteroids market?

The main drivers include the rising prevalence of dermatological conditions, growing geriatric population, technological advancements in drug formulations, and expanding product availability across different regions[3].

Sources:

1. Global Fluocinonide API Market is Experiencing a Booming Period from 2024 to 2032 - Panhandle News Channel Nebraska
2. Fluocinonide (topical application route) - Mayo Clinic
3. Topical Corticosteroids Market | Growth | Share | Size | Trends and Forecast - Reanin
4. Fluocinonide API Market Size, Scope And Forecast Report - Market Research Intellect
5. Benefits of Systemic Anti-inflammatory Therapy versus Fluocinolone - AAO Journal