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Last Updated: December 23, 2024

PHISOHEX Drug Patent Profile


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When do Phisohex patents expire, and what generic alternatives are available?

Phisohex is a drug marketed by Sanofi Aventis Us and is included in two NDAs.

The generic ingredient in PHISOHEX is hexachlorophene. There are seven drug master file entries for this compound. Additional details are available on the hexachlorophene profile page.

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Summary for PHISOHEX
Drug patent expirations by year for PHISOHEX
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US Patents and Regulatory Information for PHISOHEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us PHISOHEX hexachlorophene EMULSION;TOPICAL 006882-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us PHISOHEX hexachlorophene EMULSION;TOPICAL 008402-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PHISOHEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of PHisoHex

Introduction

PHisoHex, a topical antiseptic containing hexachlorophene, has a complex history that reflects both its efficacy and the challenges it faced due to safety concerns. This article will delve into the market dynamics and financial trajectory of PHisoHex, exploring its rise, fall, and the broader implications for the pharmaceutical industry.

Historical Context of PHisoHex

PHisoHex was widely used in the 1960s and 1970s as a deodorant and antiseptic in various medical and cosmetic products. Its effectiveness in reducing bacterial counts and its mild odor made it a popular choice[4].

Market Success and Widespread Use

By the early 1970s, hexachlorophene was being manufactured at a rate of about 1.8 million kilograms annually, incorporated into over 1,500 consumer products. Its use was pervasive, from soaps to other personal care items[4].

Regulatory Challenges and Recall

However, the fortunes of PHisoHex took a dramatic turn following a tragic incident in France where 18 babies died due to exposure to a hexachlorophene-containing baby powder. This led to a comprehensive review by the FDA, resulting in a recall of products containing more than three-quarters of a percent of hexachlorophene. Approximately 600 products were recalled, and many others were moved behind the counter as prescription items[4].

Impact on the Pharmaceutical and Cosmetic Industries

The recall of PHisoHex had a significant impact on both the pharmaceutical and cosmetic industries. It led to a shift towards more natural and organic products, as consumer distrust of synthetic chemicals grew. This trend, known as the "Clean Beauty" movement, continues to influence the market today[4].

Financial Consequences

The financial impact of the recall was substantial. Companies that had heavily invested in products containing hexachlorophene saw significant drops in sales. The sudden loss of a key ingredient forced companies to reformulate their products, which was a costly and time-consuming process[4].

Current Market Status

Today, PHisoHex is no longer widely used due to its neurotoxicity and the regulatory actions taken against it. Alternative antiseptics like chlorhexidine have become more popular, offering similar efficacy without the associated risks[1].

Consumer Perception and Trust

The hexachlorophene scandal highlighted the importance of consumer trust and the need for transparency in product ingredients. Cosmetic companies now avoid advertising the presence of synthetic compounds, opting instead for a more natural and organic branding strategy[4].

Financial Trajectory of Similar Companies

While PHisoHex itself is no longer a significant player in the market, the financial trajectories of companies involved in similar sectors can provide insights. For instance, Phio Pharmaceuticals Corp., a company involved in pharmaceutical research and development, is working towards a financial turnaround. Despite facing challenges, Phio Pharmaceuticals has seen an upward trajectory in its Return on Assets (ROA) and is projected to have a revenue of $76 million by the end of 2025[2][5].

Revenue and Earnings Projections

Companies like Phio Pharmaceuticals, which are not directly related to PHisoHex but operate in the pharmaceutical sector, offer a glimpse into the financial health of the industry. Phio Pharmaceuticals is expected to see growth in revenue and earnings per share (EPS), with an average EPS of $2.82 projected for 2025[2].

EBIT and EBITDA Estimates

The financial health of a company can also be gauged by its EBIT (Earnings Before Interest and Taxes) and EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortization). For Phio Pharmaceuticals, the forecasted annual EBIT for 2025 is $64 million, indicating a positive financial outlook despite past challenges[2].

Competitive Landscape

The pharmaceutical industry is highly competitive, with companies constantly racing to develop new drugs and gain market share. The development of follow-on or 'me-too' drugs is a common strategy, which can provide therapeutic options and inject price competition into the market. However, this also means that companies must navigate complex regulatory environments and consumer preferences[3].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of pharmaceutical companies. The FDA's actions on PHisoHex highlight the importance of safety and efficacy in product approval. Companies must ensure compliance with stringent regulations to avoid recalls and financial losses[4].

Consumer Trends and Preferences

Consumer trends, such as the preference for natural and organic products, significantly impact the market dynamics of pharmaceutical and cosmetic companies. The hexachlorophene scare accelerated the shift towards cleaner, more natural products, a trend that continues to influence product development today[4].

Industry Adaptation and Innovation

The pharmaceutical and cosmetic industries have adapted to the changing regulatory and consumer landscape by innovating and diversifying their product lines. Companies now focus more on transparency, safety, and consumer preferences, which has led to the development of new, safer alternatives to traditional antiseptics like PHisoHex[4].

Key Takeaways

  • Regulatory Impact: The recall of PHisoHex due to safety concerns had a profound impact on the pharmaceutical and cosmetic industries.
  • Market Shift: The incident led to a shift towards natural and organic products, influencing consumer preferences and company strategies.
  • Financial Consequences: The recall resulted in significant financial losses for companies that had invested heavily in hexachlorophene-containing products.
  • Industry Adaptation: Companies have adapted by focusing on transparency, safety, and consumer preferences.
  • Competitive Landscape: The pharmaceutical industry remains highly competitive, with companies racing to develop new drugs and gain market share.

FAQs

What led to the recall of PHisoHex?

The recall of PHisoHex was triggered by a tragic incident in France where 18 babies died due to exposure to a hexachlorophene-containing baby powder, highlighting the neurotoxicity of the compound.

How did the recall of PHisoHex impact the cosmetic industry?

The recall led to a significant shift towards more natural and organic products, as consumer distrust of synthetic chemicals grew. This trend, known as the "Clean Beauty" movement, continues to influence the market today.

What are some alternatives to PHisoHex?

Alternatives such as chlorhexidine topical and Hibiclens (chlorhexidine) have become more popular due to their efficacy and safety profiles compared to hexachlorophene[1].

How has the financial trajectory of Phio Pharmaceuticals Corp. been?

Phio Pharmaceuticals Corp. is working towards a financial turnaround, with an upward trajectory in its ROA and projected revenue of $76 million by the end of 2025[2][5].

What is the current market status of PHisoHex?

PHisoHex is no longer widely used due to its neurotoxicity and the regulatory actions taken against it. It has been largely replaced by safer alternatives in both medical and cosmetic applications.

Sources

  1. Drugs.com - PHisoHex Alternatives Compared
  2. Fintel.io - PHIO / Phio Pharmaceuticals Corp. (NasdaqCM) - Forecast, Price
  3. PubMed - The economics of follow-on drug research and development
  4. Cosmetics and Skin - Hexachlorophene
  5. CSIMarket - Phio Pharmaceuticals Sets Sights on Financial Turnaround with New CFO at the Helm

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