VANOS Drug Patent Profile

Which patents cover Vanos, and what generic alternatives are available?

Vanos is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in VANOS is fluocinonide. There are nine drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vanos

A generic version of VANOS was approved as fluocinonide by TARO on June 10^th, 1987.

Summary for VANOS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Patent Applications:	4,997
Drug Prices:	Drug price information for VANOS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VANOS
What excipients (inactive ingredients) are in VANOS?	VANOS excipients list
DailyMed Link:	VANOS at DailyMed

See drug prices for VANOS

See drug sales revenues for VANOS

Pharmacology for VANOS

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for VANOS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VANOS	Cream	fluocinonide	0.1%	021758	1	2008-01-31

US Patents and Regulatory Information for VANOS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	VANOS	fluocinonide	CREAM;TOPICAL	021758-001	Feb 11, 2005	AB	RX	Yes	Yes

Expired US Patents for VANOS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	VANOS	fluocinonide	CREAM;TOPICAL	021758-001	Feb 11, 2005
Bausch	VANOS	fluocinonide	CREAM;TOPICAL	021758-001	Feb 11, 2005
Bausch	VANOS	fluocinonide	CREAM;TOPICAL	021758-001	Feb 11, 2005
Bausch	VANOS	fluocinonide	CREAM;TOPICAL	021758-001	Feb 11, 2005

International Patents for VANOS

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	03055445
Canada	2471041	COMPOSITIONS ET PROCEDES FAVORISANT L'ADMINISTRATION DE CORTICOSTEROIDES (COMPOSITIONS AND METHODS FOR ENHANCING CORTICOSTERIOD DELIVERY)
Mexico	PA04006014	COMPOSICIONES Y METODOS PARA INCREMENTAR EL SUMINISTRO DE CORTICOSTEROIDE. (COMPOSITIONS AND METHODS FOR ENHANCING CORTICOSTERIOD DELIVERY.)
Australia	2002360589

VANOS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: VANOS

Introduction

VANOS Cream, a topical corticosteroid containing fluocinonide, is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. To understand the market dynamics and financial trajectory of VANOS, it is crucial to analyze various factors including market trends, competition, regulatory environment, and financial performance of similar pharmaceutical products.

Market Trends in Dermatological Treatments

The market for dermatological treatments is growing, driven by increasing prevalence of skin conditions such as psoriasis and atopic dermatitis. This growth is also fueled by an aging population and rising awareness about skin health[2].

Competitive Landscape

The dermatological treatment market is highly competitive, with numerous branded and generic products available. VANOS, as a branded product, faces competition from other topical corticosteroids as well as from generic alternatives. The competitive landscape is further complicated by product hopping strategies employed by brand companies, which can reduce the market share of generic entrants[1].

Regulatory Environment

The regulatory environment plays a significant role in the market dynamics of pharmaceutical products. For VANOS, compliance with FDA regulations and guidelines is essential. The FDA's approval process and post-marketing surveillance can impact the product's market presence. Additionally, the use of biowaivers instead of in-vivo bioequivalence (BE) studies can reduce development costs and time to market, which could be beneficial for generic competitors[1].

Financial Performance of Similar Products

Companies like Perrigo and Valeant Pharmaceuticals, which operate in the dermatological and pharmaceutical sectors, provide insights into the financial performance of similar products. Perrigo, for instance, has seen significant growth in its consumer healthcare segment, which includes dermatological products. The company's strategy of increasing store brand penetration and expanding into new markets has contributed to its financial success[2].

Revenue Streams and Growth Projections

For VANOS, revenue streams are primarily driven by prescription sales. The product's financial trajectory can be influenced by several factors:

• Market Size and Penetration: The size of the market for dermatological treatments and the product's penetration within this market are crucial. VANOS, being a branded product, may benefit from strong marketing and distribution networks.
• Generic Competition: The entry of generic versions of fluocinonide can significantly impact VANOS's revenue. Studies have shown that drug prices decline after generic entry, and this decline is steeper with more generic entrants[1].
• Product Hopping: Brand companies may introduce new patented versions of their drugs to maintain market share, which can reduce the market size for generic entrants and impact VANOS's revenue if such strategies are employed[1].

Cost Factors and Development Incentives

The development and approval costs of generic drugs, including those similar to VANOS, are substantial. Factors such as FDA approval rates, ANDA submission fees, and the use of biowaivers can significantly affect these costs. For example, increasing the rate of FDA first-cycle approvals can reduce the time to market and capitalized costs for generic developers[1].

Impact of Payer and Formulary Decisions

The placement of VANOS on formulary tiers by Pharmacy Benefit Managers (PBMs) and the associated rebate system can influence the product's revenue model. While the exact impact is indeterminate, favorable formulary placement can enhance market access and revenue[1].

Global Market Expansion

Expanding into global markets can provide additional revenue streams for VANOS. Companies like Perrigo have successfully expanded into various international markets, including Canada, China, and Latin America, which can serve as a model for VANOS's global strategy[2].

R&D and Innovation

Continuous investment in research and development (R&D) is essential for maintaining a competitive edge. Valeant Pharmaceuticals, for example, has increased its R&D spending to drive innovation and launch new products, which can be a strategy for the developers of VANOS to consider[3].

Financial Goals and Projections

To project the financial trajectory of VANOS, one must consider the overall growth trends in the pharmaceutical industry, the competitive landscape, and the impact of regulatory and market factors. Here are some key financial goals and projections:

• Revenue Growth: Given the growing demand for dermatological treatments, VANOS could see steady revenue growth, especially if it maintains strong market penetration.
• Cost Management: Effective management of development and approval costs, as well as operational efficiencies, will be crucial for maintaining profitability.
• Market Expansion: Expanding into new markets and product lines can provide additional revenue streams and help mitigate the impact of generic competition.

Key Takeaways

• The market for dermatological treatments is growing, driven by increasing prevalence of skin conditions.
• VANOS faces competition from both branded and generic products, with regulatory and market factors influencing its market dynamics.
• Effective cost management, R&D investment, and global market expansion are key strategies for maintaining a strong financial trajectory.
• The impact of generic competition and product hopping strategies must be carefully managed to sustain market share.

FAQs

What are the primary indications for VANOS Cream?

VANOS Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older[4].

How does generic competition affect the revenue of branded products like VANOS?

Generic competition can significantly reduce the revenue of branded products by lowering prices and increasing market share of generic alternatives. The decline in prices is steeper with more generic entrants[1].

What role does the FDA play in the market dynamics of VANOS?

The FDA's approval process, post-marketing surveillance, and policies such as the use of biowaivers can impact the development costs, time to market, and overall market presence of VANOS[1].

How can product hopping strategies affect VANOS's market share?

Product hopping by introducing new patented versions of the brand drug can reduce the market share of VANOS and other generic entrants by up to 29% within the first year after generic entry[1].

What are the key financial goals for maintaining a strong trajectory for VANOS?

Key financial goals include managing development and approval costs, investing in R&D, expanding into new markets, and maintaining strong market penetration to mitigate the impact of generic competition.

Cited Sources

1. Office of the Assistant Secretary for Planning and Evaluation. "COST OF GENERIC DRUG DEVELOPMENT AND APPROVAL FINAL REPORT DECEMBER 31, 2021."
2. Perrigo Company. "Leveraging the Perrigo - Annual Reports."
3. Valeant Pharmaceuticals International, Inc. "VALEANT PHARMACEUTICALS INTERNATIONAL, INC. 2016 ANNUAL REPORT."
4. Drugs.com. "Vanos: Package Insert / Prescribing Information - Drugs.com."