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. 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 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:	59
Patent Applications:	6,005
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
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 E Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Florone (Diflorasone)

Introduction to Florone (Diflorasone)

Florone, also known by its generic name diflorasone, is a topical corticosteroid used to treat various skin conditions such as eczema, dermatitis, allergies, and rashes. It is available in cream and ointment forms and is marketed under several brand names, including Florone, Psorcon E, and others[2][5].

Market Position and Usage

Therapeutic Applications

Diflorasone is widely used for its anti-inflammatory and immunosuppressive properties to relieve symptoms such as redness, pain, itching, swelling, and other discomforts associated with skin conditions. Its effectiveness in treating dermatoses makes it a staple in dermatological treatments[5].

User Demographics

The medication is suitable for various age groups, including geriatric patients, although there is limited information on its effects in elderly populations. It is also used in pediatric patients, but with caution due to the potential for adrenal gland problems and other side effects[5].

Market Share and Competition

Generic vs. Branded

Diflorasone is available as both generic and branded products. The generic market is highly competitive, with multiple manufacturers producing the drug. This competition can lead to price pressures and affect the financial trajectory of companies relying on branded versions[3].

Market Trends

The market for topical corticosteroids is stable, with a consistent demand driven by the prevalence of skin conditions. However, the introduction of new treatments and changes in regulatory environments can impact market dynamics. For instance, the rise of fluoro-pharmaceuticals, while not directly competing with diflorasone, can influence overall market trends in pharmaceuticals[4].

Financial Performance

Revenue Streams

Companies that manufacture and distribute diflorasone derive revenue primarily from sales of the medication through various channels, including pharmacies, hospitals, and retail networks. The revenue is influenced by factors such as pricing, market penetration, and competition from other treatments.

Pricing Dynamics

The pricing of generic drugs like diflorasone tends to be lower than that of branded drugs. However, the prices can fluctuate based on market conditions, regulatory changes, and the availability of raw materials. For example, generic drugs often see a significant price drop after the expiration of patents, which can impact revenue projections[3].

Key Financial Metrics

Sales Growth

The sales growth of diflorasone is generally stable but can be influenced by the introduction of new products and changes in market demand. For companies like Pharmaceutical Resources, Inc. (PRX), revenue growth is often driven by new product introductions rather than existing products like diflorasone[3].

Gross Margin

The gross margin for generic drugs typically decreases over time as the drug moves through its lifecycle. After the exclusivity period ends, the price of the drug can drop substantially, leading to a decrease in gross margin. For example, the gross margin for generic drugs can decrease from 50% to 35% over a few years[3].

Regulatory and Legal Factors

Approval and Distribution

The distribution and approval of diflorasone are regulated by health authorities such as the FDA. Any changes in regulatory requirements or legal challenges can affect the availability and pricing of the drug. For instance, delays in the approval of generic versions of other drugs can impact the overall market dynamics and pricing strategies[1].

Controlled Distribution

Some pharmaceuticals, though not specifically diflorasone, may have controlled distribution systems to prevent shortages or ensure proper use. This can add complexity to the supply chain and affect the financial performance of companies involved[1].

Industry Expert Insights

Market Penetration

Industry experts emphasize the importance of market penetration and the continuation of existing distribution agreements for maintaining revenue streams. New product introductions and the approval of Abbreviated New Drug Applications (ANDAs) are critical for growth in the pharmaceutical industry[3].

Price Erosion

Experts also highlight the rapid price erosion that occurs once a generic drug's exclusivity period ends. This can significantly impact the revenue and profitability of companies relying on these drugs[3].

Illustrative Statistics

• The sales of generic drugs can increase significantly with new product introductions. For example, PRX saw a 231% increase in net sales from $55 million to $182 million over a year due to new products[3].
• The price of generic drugs can drop to 30% of the branded drug price after the exclusivity period ends, leading to substantial revenue decreases[3].

Examples and Case Studies

Pharmaceutical Resources, Inc. (PRX)

PRX's financial performance is a good example of how new product introductions and generic drug dynamics can impact revenue. The company's revenue growth was largely driven by new products, while existing products contributed minimally to the growth[3].

Challenges and Opportunities

Competition and Pricing Pressures

The generic pharmaceutical market is highly competitive, leading to pricing pressures and reduced profit margins over time. Companies must continually introduce new products and negotiate favorable distribution agreements to maintain market share[3].

Regulatory Changes

Changes in regulatory environments can present both challenges and opportunities. For instance, delays in generic approvals can temporarily protect branded drug prices but also delay market entry for generic competitors[1].

Key Takeaways

• Stable Demand: Diflorasone has a stable market demand due to its effectiveness in treating skin conditions.
• Pricing Dynamics: Generic drugs like diflorasone experience significant price drops after the exclusivity period ends.
• Regulatory Impact: Regulatory changes and legal challenges can affect the availability and pricing of the drug.
• Market Penetration: Continuous market penetration and new product introductions are crucial for revenue growth.
• Financial Metrics: Gross margin decreases over time as the drug moves through its lifecycle.

Frequently Asked Questions (FAQs)

Q: What is Florone (diflorasone) used for? A: Florone is used to treat various skin conditions such as eczema, dermatitis, allergies, and rashes.

Q: Is Florone suitable for all age groups? A: Yes, Florone is suitable for various age groups, including geriatric patients, although caution is advised for pediatric patients due to potential side effects.

Q: How does the pricing of generic diflorasone change over time? A: The pricing of generic diflorasone tends to drop significantly after the exclusivity period ends, often to 30% of the branded drug price.

Q: What factors influence the revenue growth of companies manufacturing diflorasone? A: Revenue growth is influenced by factors such as pricing levels, competition, market penetration, and the introduction of new products.

Q: How do regulatory changes impact the market dynamics of diflorasone? A: Regulatory changes can affect the availability and pricing of the drug, as well as the timing of generic entries into the market.

Cited Sources

1. Department of Defense Pharmacoeconomic Center - Cumulative Minutes 2001[1]
2. WebMD - Florone Cream - Uses, Side Effects, and More[2]
3. Yale SOM Security Analysis - Pharmaceutical Resources, Inc. (PRX)[3]
4. ACS Omega - Contribution of Organofluorine Compounds to Pharmaceuticals[4]
5. Mayo Clinic - Diflorasone (topical application route)[5]