DIFLORASONE DIACETATE - Generic Drug Details

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

Diflorasone diacetate is the generic ingredient in five branded drugs marketed by Ani Pharms, Avondale Pharms, Taro, Pfizer, Taro Pharms North, Rising, Sciegen Pharms Inc, and The J Molner, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for diflorasone diacetate. Five suppliers are listed for this compound.

Summary for DIFLORASONE DIACETATE

US Patents:	0
Tradenames:	5
Applicants:	8
NDAs:	13
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	59
Patent Applications:	5,420
Drug Prices:	Drug price trends for DIFLORASONE DIACETATE
What excipients (inactive ingredients) are in DIFLORASONE DIACETATE?	DIFLORASONE DIACETATE excipients list
DailyMed Link:	DIFLORASONE DIACETATE at DailyMed

See drug prices for DIFLORASONE DIACETATE

Pharmacology for DIFLORASONE DIACETATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for DIFLORASONE DIACETATE

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

US Patents and Regulatory Information for DIFLORASONE DIACETATE

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	PSORCON E	diflorasone diacetate	OINTMENT;TOPICAL	017994-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	FLORONE E	diflorasone diacetate	CREAM;TOPICAL	019259-001	Aug 28, 1985		DISCN	No	No
Ani Pharms	DIFLORASONE DIACETATE	diflorasone diacetate	CREAM;TOPICAL	076263-001	Dec 20, 2002		DISCN	No	No
Avondale Pharms	DIFLORASONE DIACETATE	diflorasone diacetate	OINTMENT;TOPICAL	075374-001	Apr 27, 1999	AB	RX	No	No

Expired US Patents for DIFLORASONE DIACETATE

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
Pfizer	PSORCON E	diflorasone diacetate	OINTMENT;TOPICAL	017994-001	Approved Prior to Jan 1, 1982
Pfizer	PSORCON	diflorasone diacetate	OINTMENT;TOPICAL	019260-001	Aug 28, 1985
Pfizer	FLORONE E	diflorasone diacetate	CREAM;TOPICAL	019259-001	Aug 28, 1985

DIFLORASONE DIACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diflorasone Diacetate

Introduction to Diflorasone Diacetate

Diflorasone diacetate is a high-potency topical corticosteroid used to treat the inflammatory and pruritic manifestations of various skin conditions, including psoriasis, atopic dermatitis, and other dermatoses. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Context: Global Topical Corticosteroids Market

The global topical corticosteroids market is a significant segment within the pharmaceutical industry, driven by the increasing prevalence of dermatological conditions such as eczema, psoriasis, and dermatitis. As of 2023, this market was valued at USD 4,270.71 million and is expected to grow to USD 6,102.07 million by 2030, with a Compounded Annual Growth Rate (CAGR) of 5.2%[3].

Drivers of Market Growth

Rising Dermatological Conditions

The increasing incidence of skin disorders is a primary driver for the demand of topical corticosteroids like diflorasone diacetate. Conditions such as eczema, psoriasis, and atopic dermatitis are becoming more prevalent, necessitating effective treatments[3].

Increasing Geriatric Population

The geriatric population is more prone to skin-related issues, which has further fueled the demand for topical corticosteroids. This demographic shift is expected to continue driving market growth[3].

Growing Healthcare Awareness

Increased awareness about maintaining healthy skin and the importance of treating dermatological conditions has led to higher demand for topical corticosteroids. Educational initiatives and robust marketing campaigns by pharmaceutical companies have also contributed to this trend[3].

Advancements in Formulations

Technological advancements in drug formulations have led to the development of more effective and safer topical corticosteroids. This includes the availability of various forms such as creams, ointments, lotions, and gels, which cater to different patient needs and preferences[3].

Market Restraints

Side Effects and Safety Concerns

Prolonged use of topical corticosteroids like diflorasone diacetate can lead to side effects such as skin thinning and hormonal imbalances, including adrenal suppression. These concerns can limit market growth and necessitate careful prescribing practices[1][4].

Regulatory Policies

Strict regulatory policies govern the approval and use of topical corticosteroids. These regulations can sometimes slow down market entry for new products and formulations[3].

High Treatment Costs

The cost of treatment with topical corticosteroids can be a barrier, especially in regions with limited healthcare resources. This can affect market penetration and growth[3].

Financial Trajectory of Diflorasone Diacetate

Revenue Contribution

Diflorasone diacetate ointment and cream formulations contribute significantly to the revenues of pharmaceutical companies that manufacture them. For instance, Teligent, Inc. reported that diflorasone diacetate ointment accounted for 15% of their total revenues in 2019[2].

Market Expansion and Product Availability

The expansion of product availability across different regions, supported by robust marketing campaigns and improved healthcare infrastructure, has been crucial for the financial success of diflorasone diacetate. Pharmaceutical companies are leveraging advancements in logistics and supply chain management to enhance product reach[3].

Research and Development

Companies are investing in research and development to introduce innovative products with minimal side effects. This includes developing new formulations and concentrations of diflorasone diacetate to improve therapeutic outcomes and patient compliance[3].

Emerging Markets

Emerging markets, particularly in Asia and Latin America, offer significant growth 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, further driving financial growth[3].

Company-Specific Financials

Teligent, Inc.

Teligent, Inc., a company involved in the development, manufacturing, and marketing of generic pharmaceutical products, including topical corticosteroids like diflorasone diacetate, has faced financial challenges. Despite these, the company continues to focus on expanding its private label and contract manufacturing services. The expansion of their manufacturing facility to include sterile injectable products is expected to support long-term growth prospects[2].

Liquidity and Funding

Companies like Teligent, Inc. have experienced liquidity issues and have engaged in equitization and refinancing efforts. As of 2021, Teligent had approximately $25.2 million in cash and cash equivalents and was exploring other strategic cash-raising options[2].

Key Takeaways

• Market Growth: The global topical corticosteroids market, including diflorasone diacetate, is expected to grow significantly driven by rising dermatological conditions and an increasing geriatric population.
• Financial Contribution: Diflorasone diacetate formulations contribute substantially to the revenues of pharmaceutical companies.
• Market Expansion: Expanding product availability and robust marketing campaigns are key drivers of financial success.
• Research and Development: Continuous investment in R&D to develop safer and more effective formulations is crucial.
• Emerging Markets: Asia and Latin America offer significant growth potential due to increasing awareness and disposable incomes.

FAQs

What are the primary uses of diflorasone diacetate?

Diflorasone diacetate is used to treat the inflammatory and pruritic manifestations of various skin conditions, including psoriasis, atopic dermatitis, and other dermatoses[1][4].

What are the potential side effects of diflorasone diacetate?

Potential side effects include skin thinning, hormonal imbalances, and adrenal suppression, especially with prolonged use[1][4].

How is the global topical corticosteroids market expected to grow?

The market is expected to grow from USD 4,270.71 million in 2023 to USD 6,102.07 million by 2030, with a CAGR of 5.2%[3].

What role do emerging markets play in the growth of diflorasone diacetate?

Emerging markets in Asia and Latin America offer significant growth potential due to increasing disposable incomes and growing awareness about dermatological treatments[3].

How do pharmaceutical companies enhance the availability of diflorasone diacetate?

Companies leverage advancements in logistics, supply chain management, and robust marketing campaigns to improve product reach and availability[3].

Sources

1. DailyMed: DIFLORASONE DIACETATE cream - DailyMed
2. Teligent, Inc.: Annual Reports - Teligent, Inc.
3. Reanin: Global Topical Corticosteroids Market | Growth | Share | Size | Trends and ...
4. DrugBank: Diflorasone: Uses, Interactions, Mechanism of Action - DrugBank