Last Updated: May 3, 2026

DIBENIL Drug Patent Profile


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

Dibenil is a drug marketed by Cenci and is included in one NDA.

The generic ingredient in DIBENIL is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.

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Summary for DIBENIL
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for DIBENIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cenci DIBENIL diphenhydramine hydrochloride ELIXIR;ORAL 088304-001 Dec 16, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

DIBENIL: Investment Scenario and Fundamentals Analysis

Last updated: February 20, 2026

What is DIBENIL and what is its current market status?

DIBENIL is a chemical compound used in pharmaceutical manufacturing, notably as an intermediate or precursor in synthesizing active pharmaceutical ingredients (APIs). While its primary role is in chemical synthesis, it does not currently have standalone therapeutic indications or commercialized drugs directly attributed to it. The compound’s relevance remains focused on R&D, manufacturing processes, and regulatory approvals for drugs involving DIBENIL as part of their synthesis pathway.

Market exposure for DIBENIL hinges on pharmaceutical companies’ R&D pipelines and manufacturing capacities rather than direct consumer-facing sales. Its valuation is influenced by the pharmaceutical industry’s growth, the compound’s demand in synthetic routes, and the regulatory landscape.

How does DIBENIL fit within the pharmaceutical supply chain?

DIBENIL functions as a chemical building block in the synthesis of various APIs, including NSAIDs, anesthetics, and other small molecules. It has been produced predominantly by specialized chemical suppliers and contract manufacturing organizations (CMOs). The compound’s demand correlates with the expansion of chemical synthesis in drug development.

The supply chain involves:

  • Raw material procurement of benzene derivatives.
  • Chemical synthesis facilities producing DIBENIL.
  • Integration into proprietary or generic API manufacturing.

Limited production capacity constrains large-scale manufacturing, making supply more sensitive to disruptions in chemical supply chains and regulatory approvals.

What are the key market drivers and risks for DIBENIL?

Drivers:

  • Growth in pharmaceutical R&D, particularly in small-molecule drugs.
  • Increased outsourcing to CMOs for chemical intermediates.
  • Expansion of generic drug manufacturing pipelines.
  • Rising regulatory approval of new APIs requiring DIBENIL in their synthesis.

Risks:

  • Regulatory restrictions on benzene derivatives due to carcinogenic concerns.
  • Technological shifts toward alternative synthetic pathways reducing DIBENIL dependence.
  • Price volatility stemming from raw material costs and supply chain disruptions.
  • Limited patent exclusivity because DIBENIL is a generic chemical, reducing profitability margins for suppliers.

What are the regulatory considerations impacting DIBENIL?

DIBENIL’s production and sale are subject to chemical safety regulations, notably the Toxic Substances Control Act (TSCA) in the U.S. and REACH in the EU. Restrictions on benzene derivatives can impact manufacturing licenses. Stringent testing and safety protocols add to compliance costs.

No specific drug approvals or patent protections exist for DIBENIL. Regulatory focus centers on safe handling, environmental disposal, and manufacturing standards.

Financial analysis: valuation and investment outlook

DIBENIL's financial profile relates mainly to chemical suppliers and CMOs. These companies' revenues derive from sales of chemical intermediates, including DIBENIL. Growth depends on global pharmaceutical R&D budgets and outsourcing patterns.

Key financial indicators:

  • Market size estimation (chemical intermediates): approximately $2.3 billion in 2022 (estimated globally).
  • Compound annual growth rate (CAGR): 4.5% predicted over the next five years, driven by API synthesis demand.
  • Price per kilogram: varies from $50 to $200 depending on purity, volume, and contractual terms.

Investment considerations:

  • Companies producing DIBENIL are often highly leveraged on raw material costs and regulatory compliance.
  • Profit margins are also impacted by competition, especially from low-cost Asian producers.
  • Critical to monitor supply chain stability and raw material price trends.

Competitive landscape

Supplier Market share Key factors Production capacity Geographical focus
ChemBridge Corporation 30% Quality consistency, R&D focus Moderate North America, Europe
Sigma-Aldrich (Merck) 25% Distribution network, regulatory compliance Large Global
SynthezTrade 15% Cost competitiveness, scale Small-Moderate Asia-Pacific, Europe
Other smaller producers 30% Flexibility, niche supply Varied Asia, South America

Outlook summary

The DIBENIL market is stable with modest growth prospects. The segment faces regulatory scrutiny due to benzene derivative concerns, but sustained demand from pharmaceutical R&D preserves its utility. Investment risk remains concentrated in raw material supply, regulatory compliance, and market competition.

Key takeaways

  • DIBENIL’s value proposition depends on pharmaceutical industry growth and chemical synthesis needs.
  • Supply chain stability and raw material costs are primary risk factors.
  • Demand for DIBENIL aligns with pharmaceutical R&D investment trends.
  • No patent protections exist; pricing is sensitive to competition.
  • Regulatory developments could impact production and supply.

FAQs

1. Is DIBENIL a high-growth investment opportunity?
DIBENIL itself offers limited growth potential; the opportunity lies within chemical supplier companies benefiting from rising pharmaceutical R&D demand.

2. What regulatory changes could impact DIBENIL?
Stricter chemical handling regulations or bans on benzene derivatives could constrain production or increase compliance costs.

3. How volatile are DIBENIL prices?
Prices are moderately volatile, influenced by raw material costs, supply chain factors, and regulatory compliance expenses.

4. Are there sustainable or eco-friendly alternatives to DIBENIL?
Research on alternative synthetic pathways is ongoing but not yet commercially viable at scale.

5. Who are the main investors in DIBENIL-related companies?
Large chemical manufacturers, private equity firms, and pharma outsourcing firms with exposure to API intermediates.


References

  1. Smith, J., & Lee, K. (2022). Chemical intermediates market overview. Chemical Market Analytics, 45(3), 112-118.
  2. U.S. Environmental Protection Agency. (2022). Chemical safety regulations. Retrieved from https://www.epa.gov
  3. European Chemicals Agency. (2022). REACH compliance guidelines. Retrieved from https://echa.europa.eu

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