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Last Updated: March 18, 2026

FLURANDRENOLIDE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Flurandrenolide

A generic version of FLURANDRENOLIDE was approved as flurandrenolide by PADAGIS ISRAEL on August 30th, 2016.

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Summary for FLURANDRENOLIDE
US Patents:0
Applicants:4
NDAs:5

US Patents and Regulatory Information for FLURANDRENOLIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx FLURANDRENOLIDE flurandrenolide CREAM;TOPICAL 205342-001 Apr 13, 2016 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Padagis Israel FLURANDRENOLIDE flurandrenolide LOTION;TOPICAL 207133-001 Aug 30, 2016 RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Alpharma Us Pharms FLURANDRENOLIDE flurandrenolide LOTION;TOPICAL 087203-001 Apr 29, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Chartwell Rx FLURANDRENOLIDE flurandrenolide LOTION;TOPICAL 205343-001 Dec 22, 2016 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Teligent FLURANDRENOLIDE flurandrenolide OINTMENT;TOPICAL 207851-001 Dec 30, 2016 RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Flurandrenolide Investment Scenario and Fundamentals Analysis

Last updated: February 20, 2026

What is Flurandrenolide?

Flurandrenolide is a topical corticosteroid used primarily for inflammatory skin conditions such as eczema, psoriasis, and dermatitis. It is marketed under various brand names, including Cordran Tape and Flurandrenolide Topical. The drug is typically formulated as a patch or ointment and is classified as a potent corticosteroid.

Market Overview

The global topical corticosteroids market was valued at approximately USD 4.1 billion in 2022 and is projected to reach USD 5.7 billion by 2028, growing at a compound annual growth rate (CAGR) of 5.6%.[1] Flurandrenolide accounts for a niche but stable segment within this market.

Regulatory Status and Patent Landscape

Patent Position

  • The original patent for flurandrenolide expired in the late 1990s.
  • Several generic formulations entered the market subsequently, reducing barriers to entry.
  • No recent new chemical entity (NCE) patent filings have been reported for flurandrenolide, indicating limited exclusivity.

Regulatory Approval

  • Approved by the FDA since the 1960s.
  • Used in multiple jurisdictions with varying patent protections.
  • No recent amendments or new formulations pending approval, limiting near-term regulatory exclusivity advantages.

Commercial Drivers

Market Penetration and Physician Preference

  • Prescribed mainly for short-term use; long-term adherence remains moderate.
  • Competed against other potent corticosteroids like betamethasone and clobetasol, which have broader brand recognition.

Pricing and Reimbursement

  • Generic competition has driven prices down significantly.
  • Reimbursement policies favor lower-cost generics, constraining profit margins.

Strategic Opportunities

  • Development of novel formulations, such as drug-eluting patches, could extend market life.
  • Potential use in combination therapies for refractory skin conditions.

Investment Risks

Patent Expiry and Generics

  • The absence of patent protection increases exposure to price erosion.
  • Market share depends on the ability of brand or new formulations to differentiate.

Regulatory and Clinical Development

  • Limited pipeline development reduces upside potential.
  • Potential regulatory hurdles for new formulations or indications.

Market Size Constraints

  • Narrow therapeutic indication limits expansion opportunities.
  • Competition from other corticosteroids with broader applications.

Financial Fundamentals

Parameter Data Notes
Market Size (2022) USD 4.1 billion Based on global corticosteroid market data
CAGR (2023-2028) 5.6% Industry-wide projection
Patent Life Expired in late 1990s No current patent exclusivity
Key Competitors Clobetasol, betamethasone, others Dominant in the corticosteroid segment
Pricing (average for generic) USD 5-10 per tube/patch Lower margins due to competition
Estimated R&D Investment for New Formulations USD 10-20 million For incremental formulations or delivery systems

Strategic Investment Considerations

  • The current market presents a stable but mature opportunity.
  • Licensing and co-development agreements could provide incremental revenue.
  • Investment in innovative delivery mechanisms offers growth potential but entails data and regulatory costs.

Key Takeaways

Flurandrenolide faces limitations due to patent expiration, resulting in high competition from generics. Its market is stable but constrained by narrow indications and declining pricing power. Innovation in delivery systems or combination therapies could extend its commercial viability but requires substantial investment.

FAQs

1. How does flurandrenolide compare to other corticosteroids?
It is a potent corticosteroid primarily used topically. Compared to others like clobetasol, it has a similar efficacy profile but may vary in safety and tolerability.

2. What are the main barriers for new entrants?
Generic competition, limited patent protection, and mature market status hinder new market entry.

3. Is there potential for pipeline expansion?
Limited pipeline development exists; however, reformulations such as transdermal patches could open new opportunities.

4. Which regions offer the highest growth potential?
Emerging markets in Asia and Latin America show increasing demand due to rising skin conditions prevalence and expanding healthcare infrastructure.

5. What is the outlook for profitability?
Highly competitive pricing pressures depress margins; profitability depends on differentiation strategies and cost management.


References

[1] Market Research Future. (2022). Topical Corticosteroids Market Size, Share & Industry Analysis. Retrieved from https://marketresearchfuture.com

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