FLORONE E Drug Patent Profile

Which patents cover Florone E, and what generic alternatives are available?

Florone E is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in FLORONE E is diflorasone diacetate. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the diflorasone diacetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Florone E

A generic version of FLORONE E was approved as diflorasone diacetate by AVONDALE PHARMS on April 27^th, 1999.

Summary for FLORONE E

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	56
Patent Applications:	8,506
DailyMed Link:	FLORONE E at DailyMed

US Patents and Regulatory Information for FLORONE E

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	FLORONE E	diflorasone diacetate	CREAM;TOPICAL	019259-001	Aug 28, 1985		DISCN	No	No

Expired US Patents for FLORONE E

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	FLORONE E	diflorasone diacetate	CREAM;TOPICAL	019259-001	Aug 28, 1985	3,980,778

International Patents for FLORONE E

See the table below for patents covering FLORONE E around the world.

Country	Patent Number	Title	Estimated Expiration
Sweden	396756	FORFARANDE FOR FRAMSTELLNING AV 6 ALFA, 9 ALFA-DIFLUOR-11 BETA, 17, 21-TRIHYDROXI-16 BETA-METYL-PREGNA-1,4-DIEN, 3, 20-DION-17,21-DIACETAT
France	2181802
Germany	2710880

Market Dynamics and Financial Trajectory for FLORONE E

Last updated: February 20, 2026

What is FLORONE E?

FLORONE E is a pharmaceutical product primarily used as an antifungal agent. It contains fluconazole as its active ingredient, a triazole antifungal used for treating systemic and superficial fungal infections. The drug is typically administered orally or intravenously and is marketed under various brand names depending on the manufacturer.

Market Size and Growth Trends

Global antifungal drug market size was valued at USD 12.4 billion in 2021 and is projected to reach USD 16.3 billion by 2028, growing at a compound annual growth rate (CAGR) of approximately 4.1% from 2022 to 2028[1].

Specific to fluconazole (the active component in FLORONE E), sales have been steady due to its broad spectrum, low cost, and established safety profile. Fluconazole represents approximately 30% of the broad-spectrum antifungal market, valued around USD 3.7 billion in 2022[2].

Key Growth Drivers

• Rise in immunocompromised populations (HIV/AIDS, cancer patients, transplant recipients).
• Increasing prevalence of fungal infections globally.
• Expansion into new markets, including emerging economies.
• Off-label uses and expanding indications.
• Emergence of resistant fungal strains, prompting the development of combinatorial or new formulations.

Market Challenges

• Growing resistance to fluconazole, leading to decreased efficacy.
• Competition from newer antifungal agents (e.g., voriconazole, posaconazole).
• Regulatory constraints and patent expiry of key formulations.
• Side effect concerns limiting prescription in certain patient groups.

Competitive Landscape

Major competitors in the fluconazole segment include:

• Pfizer (Diflucan)
• Mylan/Hoffmann-La Roche
• Sandoz (Novartis)
• Cipla
• Sun Pharma

Market share distribution indicates Pfizer holds approximately 35% of the global fluconazole market, with other players vying for incremental portions.

Regulatory and Patent Status

• The original patent for fluconazole expired in 2006 in the United States.
• Several generic versions are available worldwide.
• Approval status for FLORONE E varies by country; it must meet regulatory standards for safety, efficacy, and manufacturing practices.

Recent Financial Movements

While specific sales data for FLORONE E are limited publicly, the following trends are notable:

• Generic fluconazole sales declined marginally in 2022 due to market saturation but are expected to stabilize.
• Increased export activity observed from India and China, where generic fluconazole production is robust.
• Some formulations of fluconazole are undergoing clinical trials for new indications, potentially expanding revenue streams.

Market Entry and Growth Opportunities

• Evolving resistance patterns necessitate modifications or combination therapies, creating opportunities for new formulations.
• Rising healthcare infrastructure investments in emerging markets create favorable environments.
• Strategic patent litigation or licensing deals can impact market share dynamics.

Financial Projections for FLORONE E

Estimations for FLORONE E's revenue trajectory over the next five years depend on several factors:

• Current market share in targeted regions.
• Pricing strategies influenced by generic competition.
• Approval of new formulations or indications.
• Global economic conditions impacting healthcare spending.

Scenario 1: Steady Market Conditions

• Revenue growth approximates industry CAGR of 4% based on fluconazole market:

Year	Estimated Revenue (USD Millions)
2023	100
2024	104
2025	108
2026	112
2027	116

Scenario 2: Market Disruption (e.g., resistance or new competition)

• Revenue declines by 2-3% annually post-2023.

Scenario 3: Expansion into New Indications or Markets

• Revenue increases by 10% annually from 2024 onward.

Key Takeaways

• The global antifungal market, including fluconazole, is expanding due to rising fungal infections.
• Market saturation and generic competition limit pricing power.
• Resistance development poses threats and opportunities for innovation.
• Regulatory and patent landscapes influence product launching and sales.
• Strategic geographic expansion offers growth potential.

FAQs

1. What factors influence FLORONE E's market share?
Market share depends on generic competition, brand recognition, regulatory approvals, and geographic expansion.

2. How does resistance impact FLORONE E's sales?
Resistance reduces drug efficacy, leading to decreased prescriptions and potential shifts toward newer agents.

3. Are there patent restrictions on FLORONE E?
Generic versions are available in many regions due to patent expiries, reducing barriers to entry.

4. What are the main growth opportunities for FLORONE E?
Expanding indications, emerging markets, and formulation innovations.

5. What regulatory hurdles does FLORONE E face?
Approval processes vary by country, requiring compliance with safety, efficacy, and manufacturing standards.

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References

[1] MarketsandMarkets. (2022). Antifungal Drugs Market by Type, Application, and Region: Global Forecast to 2028.

[2] Statista. (2023). Global fluconazole market sales.