FLORONE Drug Patent Profile

When do Florone patents expire, and when can generic versions of Florone launch?

Florone is a drug marketed by Pfizer and is included in two NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Florone

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

Summary for FLORONE

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	59
Patent Applications:	5,365
DailyMed Link:	FLORONE at DailyMed

US Patents and Regulatory Information for FLORONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	FLORONE	diflorasone diacetate	CREAM;TOPICAL	017741-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	FLORONE E	diflorasone diacetate	CREAM;TOPICAL	019259-001	Aug 28, 1985		DISCN	No	No

Expired US Patents for FLORONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	FLORONE	diflorasone diacetate	CREAM;TOPICAL	017741-001	Approved Prior to Jan 1, 1982

International Patents for FLORONE

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

Country	Patent Number	Title	Estimated Expiration
Germany	2365992
Belgium	796560
France	2181802
Netherlands	7303262
Denmark	133382
Japan	S4899157
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

FLORONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Drugs Treating Vulvovaginal Candidiasis: A Case Study

Introduction to Vulvovaginal Candidiasis

Vulvovaginal candidiasis (VVC) is a common fungal infection caused by the overgrowth of Candida species, primarily Candida albicans, in the vaginal area. This condition leads to symptoms such as itching, redness, swelling, and a thick, white discharge. It can be triggered by factors including the use of antibiotics, pregnancy, or a weakened immune system[1].

Market Size and Growth

The global market for drugs treating vulvovaginal candidiasis was valued at $1.0 billion in 2023 and is projected to reach $1.6 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 4.4% from 2024 to 2033. This growth is driven by several key factors:

• Increasing Prevalence: The rise in yeast infections due to various triggers such as antibiotics, hormonal changes during pregnancy, diabetes, and a weakened immune system.
• Growing Awareness: Rising awareness of women's health issues and improved diagnostic capabilities have led to a higher rate of diagnosis and treatment.
• Advancements in Antifungal Drugs: Innovations in antifungal drug formulations and the development of new antifungal agents[1].

Key Market Drivers

Increase in Use of Antibiotics

The use of antibiotics disrupts the normal vaginal flora, leading to an overgrowth of Candida species and increasing the incidence of VVC. This trend is expected to continue, driving the demand for antifungal treatments[1].

Hormonal Changes and Health Conditions

Hormonal changes during pregnancy and conditions like diabetes contribute to the susceptibility to VVC. As the population of women at risk grows, so does the demand for effective treatments[1].

Growing Awareness and Diagnostic Capabilities

Campaigns promoting vaginal health and advancements in healthcare access, especially in developed regions, have encouraged women to seek treatment earlier. Improved diagnostic capabilities have also contributed to a higher rate of diagnosis, further increasing the demand for antifungal drugs[1].

Market Segmentation

By Drug Class

The market is segmented by drug class, which includes various antifungal agents. The development of new classes of antifungals and combination therapies is a significant growth driver, as these innovations enhance treatment efficacy and reduce recurrence rates[1].

By Route of Administration

Drugs for VVC can be administered through various routes, including topical, oral, and intravaginal. The preference for over-the-counter (OTC) medications, particularly those with convenient administration routes, is on the rise[1].

By Distribution Channel

The market is also segmented by distribution channels, including pharmacies, hospitals, and online platforms. The expansion of healthcare infrastructure in emerging markets and the growing demand for OTC medications have increased access to these treatments[1].

Regional Analysis

North America

North America holds a significant market share driven by higher healthcare spending, advanced diagnostic facilities, and increased awareness of women's health issues. The region is expected to continue its dominance due to these factors[1].

Asia-Pacific

The Asia-Pacific region is expected to witness rapid growth in the coming years, driven by expanding healthcare infrastructure, increasing awareness, and rising disposable income. Emerging economies in this region are becoming key markets for VVC treatments[1].

LAMEA (Latin America, Middle East, and Africa)

The LAMEA region is experiencing steady growth due to improving healthcare access, growing healthcare infrastructure, and heightened awareness of VVC treatment. These factors are contributing to the broader adoption of VVC treatments in these regions[1].

Competitive Landscape

The market for drugs treating VVC is highly competitive, with several major players operating in the space. Key players include:

• Astellas Pharma Inc
• Mycovia Pharmaceuticals, Inc.
• Bayer AG
• Basilea Pharmaceutica Ltd
• Scynexis, Inc.
• Grupo Ferrer Internacional S.A.
• Pfizer, Inc.
• Zydus Lifesciences Ltd.
• Bristol-Myers Squibb Company
• Amneal Pharmaceuticals LLC
• Johnson & Johnson
• Viatris Inc.[1]

Financial Trajectory

Market Value and Growth Rate

The market value of $1.0 billion in 2023 is projected to reach $1.6 billion by 2033, with a CAGR of 4.4%. This growth indicates a steady and significant increase in the demand for antifungal treatments over the forecast period[1].

Funding and Investment

The development of new drugs, including those for VVC, is heavily influenced by funding and investment. The pharmaceutical industry faces significant challenges such as large investment costs, long gestation lags, and highly uncertain payoffs. However, successful drug approvals can lead to monopoly profits during the marketing exclusivity period, typically lasting from 3 to 7 years[3].

Mergers and Acquisitions

The pharmaceutical industry has seen a trend towards consolidation through mergers and acquisitions. These activities help companies gain scale and efficiency, rationalize operations, and finance spiraling research and development budgets. Such mergers can create or destroy shareholder value but often result in increased profitability and financial performance[5].

Innovations and Future Prospects

New Antifungal Agents

Innovations targeting drug-resistant Candida strains, especially through new classes of antifungals or combination therapies, offer significant growth potential. These advancements are crucial in enhancing treatment efficacy and reducing recurrence rates[1].

Expanding Healthcare Infrastructure

The expansion of healthcare infrastructure in developing regions and increased access to medical facilities support the broader adoption of VVC treatments. This trend is expected to continue, driving market growth in these regions[1].

Key Takeaways

• The global market for drugs treating VVC is driven by increasing prevalence, growing awareness, and advancements in antifungal drug formulations.
• The market is expected to grow at a CAGR of 4.4% from 2024 to 2033, reaching $1.6 billion by 2033.
• Key drivers include the use of antibiotics, hormonal changes, and growing awareness of women's health issues.
• Innovations in antifungal agents and expanding healthcare infrastructure are significant growth drivers.
• The competitive landscape is dominated by several major pharmaceutical companies.

FAQs

What is the current market size for drugs treating vulvovaginal candidiasis?

The global market for drugs treating vulvovaginal candidiasis was valued at $1.0 billion in 2023[1].

What is the projected market size for drugs treating vulvovaginal candidiasis by 2033?

The market is projected to reach $1.6 billion by 2033[1].

What are the key drivers of the market growth for drugs treating vulvovaginal candidiasis?

Key drivers include the increase in use of antibiotics, hormonal changes during pregnancy, growing awareness of women's health issues, and advancements in antifungal drug formulations[1].

Which regions are expected to witness significant growth in the market for drugs treating vulvovaginal candidiasis?

The Asia-Pacific region and LAMEA are expected to witness significant growth due to expanding healthcare infrastructure and increasing awareness[1].

Who are the major players in the market for drugs treating vulvovaginal candidiasis?

Major players include Astellas Pharma Inc, Mycovia Pharmaceuticals, Inc., Bayer AG, Basilea Pharmaceutica Ltd, and others[1].

Sources

1. Allied Market Research: "Drugs for Vulvovaginal Candidiasis Market Research, 2033"
2. United Nations: "Transforming our world: the 2030 Agenda for Sustainable Development"
3. Carlson School of Management: "Financing Medical Innovation"
4. McKinsey & Company: "Pharma's first-to-market advantage"
5. University of Gothenburg: "Profit and Value Creation in Pharmaceutical Industry Cross-Border Mergers and Acquisitions"