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Last Updated: March 19, 2026

bentoquatam - Profile


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What are the generic sources for bentoquatam and what is the scope of freedom to operate?

Bentoquatam is the generic ingredient in one branded drug marketed by Stand Homeopath and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for bentoquatam
US Patents:0
Tradenames:1
Applicants:1
NDAs:1

US Patents and Regulatory Information for bentoquatam

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Stand Homeopath IVY BLOCK bentoquatam LOTION;TOPICAL 020532-001 Aug 26, 1996 OTC Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Last updated: February 3, 2026

mmary
Bentoquatam, a registered skin protectant used primarily against UV radiation and chemical irritants, presents a modest but stable investment profile. Its market is driven by increasing demand for sun protection and occupational safety products. The drug’s fundamentals suggest steady growth opportunities, with regulatory status and market acceptance key factors influencing investment viability.


What Is the Market Outlook for Bentoquatam?

Bentoquatam is predominantly marketed as a sunscreen agent and protective barrier against chemical exposure. It is included in OTC (over-the-counter) drug formulations and topical skin protections, especially in occupational and cosmetic sectors.

Market Size and Growth
The global skin protectant market was valued at approximately USD 2.1 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4.2% through 2030 [1]. Bentoquatam’s share is limited but stable within this segment, accounting for a significant portion of barrier creams and sunscreens.

Key Drivers:

  • Rising awareness about UV protection.
  • Increasing occupational safety regulations.
  • Growing cosmetic use of sun protection products.
  • Expanding markets in emerging economies.

Competitive Landscape:
Major competitors include zinc oxide, titanium dioxide, and other chemical barriers such as avobenzone. Bentoquatam differentiates itself through its specific chemical properties, including its ability to form a protective barrier localized on the skin’s surface.


What Are the Regulatory Fundamentals for Bentoquatam?

Current Status
Bentoquatam is approved by the U.S. Food and Drug Administration (FDA) as an OTC skin protectant, with an approved monograph for use in certain formulations [2].

Regulatory Challenges

  • Gaining approval in markets outside the U.S. (e.g., European Union, China) may involve lengthy approval processes.
  • Potential re-evaluation of safety profiles under stricter regulations could delay or restrict usage.
  • Pending or ongoing regulatory reviews (e.g., OTC monograph updates) may influence product positioning.

Implications
Regulatory approval stability underpins market confidence. Future regulatory changes might impact manufacturing, marketing, and sales.


What Are the Pharmacological and Safety Fundamentals?

Pharmacological Profile
Bentoquatam acts as a physical barrier, forming a protective film on the skin's surface. It is not absorbed systemically, which limits toxicity concerns but also constrains systemic efficacy.

Safety Data

  • Generally recognized as safe (GRAS) in approved formulations.
  • Low incidence of adverse effects; skin irritation possible in sensitive individuals.
  • No significant systemic toxicity reported at recommended dosages.

Market Acceptance
High acceptance in occupational settings; moderate in commercial sunscreen products due to competition.


What Are the Business & R&D Fundamentals?

Patent and Intellectual Property

  • The initial patents on bentoquatam formulations have expired, exposing the compound to generic competition.
  • Future patents are unlikely unless used in novel formulations or delivery systems.

R&D Pipeline

  • Limited development activities are ongoing due to established market presence.
  • Potential exists in combining bentoquatam with UV filters or enhancing formulations for broader consumer appeal.

Manufacturing Economics

  • Production costs are manageable, tied to the complexity of formulation and quality control.
  • Supply chain stability depends on raw material sourcing and regulatory compliance.

Investment Considerations

  • The stable but mature market implies limited growth upside but steady cash flow.
  • Entry points depend on licensing, product diversification, or geographic expansion.
  • Competitive edge hinges on regulatory status and formulation innovation.

Risks

  • Regulatory changes could restrict use or require reformulation.
  • Market competition from more established or innovative ingredients.
  • Patent expiry exposes brands to generic competition.

Key Takeaways

  • Bentoquatam offers a stable revenue stream as a niche skin protectant.
  • Market growth aligns with broader trends in sun and occupational protection products.
  • Regulatory approval remains a critical factor, with regional differences influencing market access.
  • Patent expirations challenge exclusivity; innovation could foster new growth avenues.
  • Cost-effective manufacturing and strategic positioning are essential to competitive resilience.

FAQs

1. How does bentoquatam compare to other skin protectants in efficacy?
It provides a physical barrier primarily against chemical irritants and UV radiation. Its efficacy is comparable to other barrier agents like zinc oxide but less versatile for broad-spectrum UV protection.

2. Are there significant safety concerns associated with bentoquatam?
No major safety issues are reported at approved doses. Minor skin irritation can occur, but systemic toxicity is minimal.

3. Can bentoquatam be used in sunlight and occupational settings?
Yes, it is approved for use as a sunscreen and occupational barrier agent, especially in chemical-heavy industries.

4. What are the key regulatory hurdles for expanding bentoquatam’s market?
Gaining approval outside the U.S., adapting formulations to regional standards, and navigating potential safety re-evaluations.

5. What strategic moves could enhance investment returns?
Innovating formulations, pursuing patent protections for new delivery systems, and entering emerging markets could improve growth prospects.


Sources
[1] MarketWatch, "Skin Protectant Market Report," 2022.
[2] FDA, OTC Monograph for Skin Protectants, 2014.

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