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Last Updated: December 23, 2024

HEXACHLOROPHENE - Generic Drug Details


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What are the generic drug sources for hexachlorophene and what is the scope of patent protection?

Hexachlorophene is the generic ingredient in sixteen branded drugs marketed by Vestal Labs, Xttrium, Huntington Labs, Sanofi Aventis Us, Bayer Pharms, Arbrook, Dial, Calgon, Becton Dickinson, Prof Dspls, Davis And Geck, and 3M, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for hexachlorophene.

Summary for HEXACHLOROPHENE
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Medical Subject Heading (MeSH) Categories for HEXACHLOROPHENE
Anatomical Therapeutic Chemical (ATC) Classes for HEXACHLOROPHENE

US Patents and Regulatory Information for HEXACHLOROPHENE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Pharms SOY-DOME hexachlorophene EMULSION;TOPICAL 017405-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Vestal Labs SEPTISOL hexachlorophene SOLUTION;TOPICAL 017423-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
3m SCRUBTEAM SURGICAL SPONGEBRUSH hexachlorophene SPONGE;TOPICAL 017413-001 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

HEXACHLOROPHENE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Hexachlorophene

Introduction

Hexachlorophene, a synthetic compound with antiseptic, bactericidal, and fungicidal properties, was once a staple in various consumer and medical products. Its market dynamics and financial trajectory are marked by significant highs and abrupt lows, largely due to safety concerns and regulatory actions.

Early Success and Market Penetration

In the 1940s and 1950s, hexachlorophene gained widespread acceptance and was incorporated into a variety of products, including soaps, cleansers, toothpastes, and cosmetics. The launch of Dial soap by Armour in 1948, which contained hexachlorophene, was particularly successful, making Dial the top-selling soap in the United States by 1954[1].

Extensive Use in Consumer Products

Hexachlorophene was used in numerous consumer goods, such as surgical scrubs, anti-dandruff shampoos, general deodorants, and feminine deodorant sprays. Its application in the adolescent and problem skin market was particularly prominent, with products like Max Factor’s Skin Clear Medicated Cleanser and Helena Rubinstein’s Beauty Dew Cleansing Cream[1].

Economic Impact During the Peak

By the early 1970s, hexachlorophene was a key ingredient in over 1,500 products, with annual production reaching about 1.8 million kilograms (four million pounds). This widespread use contributed significantly to the revenue of companies manufacturing these products, making hexachlorophene a lucrative component in the pharmaceutical and cosmetic industries[1].

Regulatory Actions and Safety Concerns

However, the success of hexachlorophene was short-lived. In the 1970s, studies indicated that hexachlorophene could be absorbed into the body and affect the nervous system. A critical incident in France, where infants died after being dusted with talcum powder containing a high level of hexachlorophene, led to immediate regulatory action. In 1972, the U.S. Food and Drug Administration (FDA) issued a recall of consumer products containing more than 0.75% hexachlorophene[1].

Market Contraction and Financial Impact

The FDA's recall notice had a profound impact on the market. Approximately 600 products containing hexachlorophene were recalled, and many others were moved behind the counter as prescription products. This led to a significant decline in the use and sales of hexachlorophene-containing products, resulting in substantial financial losses for the companies involved[1].

Shift to Alternative Ingredients

Following the recall, cosmetic and pharmaceutical companies began to replace hexachlorophene with other ingredients. This shift was part of a broader trend towards more 'natural' and 'natural-looking' products, which accelerated due to consumer distrust of synthetic chemicals. Companies became more cautious about advertising the presence of synthetic ingredients in their products[1].

Current Market Status

Today, hexachlorophene is no longer a dominant ingredient in consumer products. Its use is heavily restricted due to its neurotoxicity, and it is primarily used in limited medical contexts where its benefits outweigh the risks. The global market for hexachlorophene has significantly contracted, and it is no longer a major contributor to the revenue of pharmaceutical or cosmetic companies.

Financial Trajectory

The financial trajectory of hexachlorophene is characterized by a rapid rise followed by a sharp decline. The compound's peak in the 1950s and 1960s was marked by high production volumes and significant revenue generation. However, the regulatory actions and safety concerns in the 1970s led to a drastic reduction in its use and sales, resulting in substantial financial losses.

Key Statistics

  • Peak Production: About 1.8 million kilograms (four million pounds) annually by the early 1970s[1].
  • Number of Products Affected: Over 1,500 products contained hexachlorophene, with around 600 recalled[1].
  • Regulatory Action: FDA recall of products containing more than 0.75% hexachlorophene in 1972[1].

Conclusion

Hexachlorophene's market dynamics and financial trajectory serve as a cautionary tale about the importance of safety and regulatory compliance in the pharmaceutical and cosmetic industries. From its initial success to its eventual decline, hexachlorophene's story highlights the critical role of consumer safety and regulatory oversight in shaping market outcomes.

Key Takeaways

  • Hexachlorophene was widely used in consumer and medical products in the 1950s and 1960s.
  • Regulatory actions due to safety concerns led to a significant decline in its use.
  • The compound's market has contracted substantially since the 1970s.
  • Consumer distrust of synthetic chemicals accelerated the shift towards 'natural' products.
  • Regulatory compliance is crucial for the sustainability of pharmaceutical and cosmetic products.

FAQs

What was the primary use of hexachlorophene in cosmetics?

Hexachlorophene was primarily used in the adolescent and problem skin market, in products such as cleansers, masks, and other skin-care items to combat bacteria associated with pimples and acne[1].

Why was hexachlorophene recalled by the FDA?

The FDA recalled hexachlorophene-containing products due to studies indicating its absorption into the body and potential to affect the nervous system, as well as a tragic incident in France where infants died after exposure to high levels of hexachlorophene[1].

How did the recall affect the market for hexachlorophene?

The recall led to the removal of hexachlorophene from over 600 products, and many others were moved behind the counter as prescription products. This resulted in a significant decline in its use and sales[1].

What impact did the hexachlorophene scare have on consumer trends?

The hexachlorophene scare increased consumer distrust of synthetic chemicals, accelerating the trend towards more 'natural' skin-care products and 'natural-looking' fashions in makeup[1].

Is hexachlorophene still used today?

Hexachlorophene is no longer widely used in consumer products due to its neurotoxicity. Its use is heavily restricted and primarily limited to specific medical contexts where its benefits outweigh the risks[1].

Sources

  1. Cosmetics and Skin: "Hexachlorophene" - https://www.cosmeticsandskin.com/efe/hexachlorophene.php
  2. Clinical Practice Guidelines by the Infectious Diseases Society of America: "The potential effectiveness of topical skin antiseptics, such as chlorhexidine and hexachlorophene" - https://academic.oup.com/cid/article/52/3/e18/306145?login=false
  3. DrugBank Blog: "Investment Trends in Pharmaceutical Research and Development" - https://blog.drugbank.com/investment-trends-in-pharmaceutical-research/
  4. Ken Research: "Global Hexachlorophene Market Report 2019" - https://www.kenresearch.com/industry-reports/hexachlorophene-market-report
  5. EPA: "Recognition and Management of Pesticide Poisonings: Sixth Edition" - https://www.epa.gov/sites/default/files/2015-01/documents/rmpp_6thed_final_lowresopt.pdf

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