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Last Updated: March 26, 2026

FLUOCINONIDE EMULSIFIED BASE Drug Patent Profile


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Which patents cover Fluocinonide Emulsified Base, and what generic alternatives are available?

Fluocinonide Emulsified Base is a drug marketed by Cosette, Fougera Pharms, Taro, and Teva. and is included in four NDAs.

The generic ingredient in FLUOCINONIDE EMULSIFIED BASE is fluocinonide. There are nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fluocinonide Emulsified Base

A generic version of FLUOCINONIDE EMULSIFIED BASE was approved as fluocinonide by SUN PHARMA CANADA on June 10th, 1987.

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Summary for FLUOCINONIDE EMULSIFIED BASE
Drug patent expirations by year for FLUOCINONIDE EMULSIFIED BASE
Pharmacology for FLUOCINONIDE EMULSIFIED BASE

US Patents and Regulatory Information for FLUOCINONIDE EMULSIFIED BASE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cosette FLUOCINONIDE EMULSIFIED BASE fluocinonide CREAM;TOPICAL 074204-001 Jun 13, 1995 AB2 RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Teva FLUOCINONIDE EMULSIFIED BASE fluocinonide CREAM;TOPICAL 072490-001 Feb 7, 1989 AB2 RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Fougera Pharms FLUOCINONIDE EMULSIFIED BASE fluocinonide CREAM;TOPICAL 076586-001 Jun 23, 2004 AB2 RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

FLUOCINONIDE EMULSIFIED BASE Market Analysis and Financial Projection

Last updated: February 10, 2026

Market Dynamics for Fluocionide Emulsified Base

Current Market Presence:
Fluocionide emulsified base is a topical corticosteroid used primarily for inflammatory skin conditions. Its market share is limited relative to more widely prescribed corticosteroids like clobetasol and betamethasone, especially in dermatology markets of North America and Europe. The compound is available through multiple generic manufacturers, with few branded options.

Competitive Landscape:
The drug faces competition from other topical corticosteroids with broader indications, longer clinical history, and established prescribing patterns. Generic proliferation pressures margins for branded formulations and reduces overall market growth prospects.
Makers of fluocionide emulsified base primarily operate in niche dermatological segments, including psoriasis and eczema. Prescribing shifts toward newer or more potent corticosteroids, or non-steroidal alternatives, influence demand.

Regulatory and Patent Status:
The patent for fluocionide emulsified base expired across major markets (e.g., US, Europe) over the last decade. It remains off-patent, making entry easier for generics. Regulatory pathways are straightforward due to longstanding use and established safety profiles, though newer formulations may require additional approval.

Pricing and Reimbursement:
Pricing is driven by generic competition. In markets with government healthcare programs, reimbursement rates heavily influence sales volume. The drug's low cost limits profits but ensures persistent demand in formulary lists where prescriptions are covered.

Market Drivers:

  • Increasing prevalence of dermatological conditions, especially atopic dermatitis and psoriasis.
  • Steady prescription rates in dermatology clinics.
  • Expanded use in pediatric populations, with safety profiles well understood.
  • Growing urbanization and pollution-related skin conditions.

Market Barriers:

  • Availability of newer therapies with improved efficacy or safety profiles.
  • Physician and patient preference shifting towards non-steroidal therapies.
  • Regulatory restrictions in some regions against corticosteroids for chronic use.

Financial Trajectory and Revenue Outlook

Current Revenue Estimates:
Global sales of fluocionide emulsified base are estimated between $50 million and $100 million annually. North American markets account for approximately 40%, Europe 35%, and Asia-Pacific 15%, with the remainder in Latin America and other regions[1].

Historical Growth Trends:

  • Slight decline (~1-2%) over recent five years due to generic competition and market saturation.
  • Post-pandemic resurgence in dermatology visits and prescriptions in some regions, partially offsetting declines.

Future Revenue Projections:
Forecasts suggest a compound annual growth rate (CAGR) of approximately 1-2% over the next five years, primarily driven by increased dermatological care access in emerging markets and pediatric use.
Generic supplier consolidation could influence pricing dynamics, with potential slight decrease in unit prices.

Impact Factors:

  • Emergence of non-steroidal alternatives.
  • Potential new formulations with improved safety and efficacy.
  • Regulatory changes affecting corticosteroid use duration or concentration limits.

Investment and R&D Outlook:
Limited R&D pipeline for fluocionide emulsified base itself; focus shifts toward reformulations or combination products. Innovative delivery mechanisms (e.g., foam, gel) could rekindle market interest but require significant investment.

Market Trends in Context

Aspect Detail Implication
Growing dermatology cases Increase in chronic skin conditions Maintains baseline demand
Competitive Steroids Broader potency range, newer formulations Pressures prices and market share
Regional Variations Higher growth in Asia-Pacific markets Opportunities for expansion
Regulatory shifts Restrictions on corticosteroid duration Could diminish long-term use

Key Takeaways

  • The market for fluocionide emulsified base remains stable but mature, with revenues impacted mainly by generic competition.
  • Global sales approximate $50 million to $100 million, with minimal growth projections.
  • Market drivers include increasing dermatology consultations and pediatric use; barriers involve competition from alternative therapies.
  • Future growth depends on regional expansion, reformulation, and regulatory changes affecting corticosteroid prescriptions.
  • Investment focus could shift toward developing alternative delivery forms or combining fluocionide with other agents.

Frequently Asked Questions

1. What is the primary clinical use of fluocionide emulsified base?
It treats inflammatory skin conditions such as eczema, psoriasis, and dermatitis.

2. How does the patent landscape affect market entry?
Patent expiration has allowed multiple generics, increasing competition and reducing prices.

3. Are new formulations in development?
Limited activity exists; most efforts focus on reformulations like foam or gel forms to improve patient compliance.

4. What regional markets offer growth opportunities?
Emerging markets in Asia-Pacific exhibit growth potential due to increasing dermatology service access.

5. How might regulatory changes impact the market?
Restrictions on corticosteroid potency or duration could decrease demand in certain regions.


References

[1] IQVIA, Global Dermatology Market Data, 2022.

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