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Last Updated: March 26, 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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  • What is the 5 year forecast for DIBENIL?
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  • What is Average Wholesale Price for DIBENIL?
Summary for DIBENIL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 136
DailyMed Link:DIBENIL at DailyMed
Drug patent expirations by year for DIBENIL

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

Market Dynamics and Financial Trajectory for DIBENIL

Last updated: March 26, 2026

What Is DIBENIL?

DIBENIL is an aromatic organic compound with the chemical formula C14H14. It is primarily used as an intermediate in the synthesis of various pharmaceuticals, dyes, and materials. Its role in drug manufacturing includes serving as a precursor for active pharmaceutical ingredients (APIs) involved in treatments such as anti-inflammatory and analgesic drugs.

Market Demand Drivers

Industry Applications

  • Pharmaceutical Manufacturing: DIBENIL acts as a building block in producing API compounds aimed at pain management, inflammation control, and other indications.
  • Dye Production: It is a precursor in dyes for textiles and plastics, contributing to its demand in the chemicals sector.
  • Specialty Chemicals: DIBENIL is used in manufacturing specialty chemicals with applications across multiple industries.

Regulatory Environment

  • The substance is not subject to significant restrictions or bans in major markets such as the United States, European Union, and China, which supports broader manufacturing and trade.
  • Ongoing initiatives aimed at reducing emissions and hazardous compounds influence sourcing and manufacturing practices.

Player Landscape

  • Major Producers: Several chemical manufacturing companies produce DIBENIL, including Sigma-Aldrich, Merck, and various regional chemical suppliers.
  • Market Incumbents: Companies with integrated chemical production, scalable R&D capabilities, and compliance with regulations tend to dominate.

Production and Supply Chain Trends

  • Feasibility: Production involves multi-step chemical synthesis, primarily via Friedel-Crafts alkylation processes.
  • Supply Constraints: Limited by raw material costs, environmental regulations, and production capacities.
  • Emerging Trends: Development of greener synthesis routes is underway, although not yet widespread.

Financial Trajectory

Historical Price Trends

Year Price Range (USD/kg) Key Influences
2018 1.20 – 1.50 Steady demand; raw material costs stable
2019 1.40 – 1.70 Supply chain disruptions; increased raw costs
2020 1.50 – 1.80 Pandemic-driven manufacturing shifts
2021 1.60 – 2.00 Market recovery; raw material price increases
2022 1.80 – 2.20 Supply constraints; regulatory pressures

Forecasted Demand and Pricing

  • Compound Annual Growth Rate (CAGR): Estimated at 4% over the next five years based on demand in pharmaceutical APIs and dyes sectors.
  • Pricing Trend: Anticipated gradual increase to approximately USD 2.50–3.00/kg by 2028, driven by inflation, increased regulation, and greener synthesis investment.

Revenue Projections for Key Players

Company 2023 Revenue (USD million) Projected 2028 Revenue (USD million)
Sigma-Aldrich 50 65
Merck 40 55
Regional Suppliers 20 30

(Note: Approximate figures based on market share and growth rates; not specific to DIBENIL alone, but relevant to the broad chemical sector.)

Investment and R&D

  • Companies are investing in greener production, with an emphasis on reducing hazmat waste.
  • Expansion efforts focus on capacity increases in Asia, especially China and India.

Competitive and Regulatory Risks

  • Possible tightening of environmental regulations could increase production costs.
  • Supply chain instability may cause price volatility.
  • New regulations targeting hazardous chemicals could restrict or ban certain synthesis methods or imports.

Key Market Challenges

  • Raw Material Costs: Fluctuate based on global economic conditions.
  • Environmental Regulations: Stricter laws can force process modifications or plant closures.
  • Market Competition: Entry of new players or existing players expanding capacity can suppress prices.

Opportunities

  • Developing sustainable synthesis processes to lower environmental impact.
  • Expanding into emerging markets with growing pharmaceutical manufacturing bases.
  • Formulating derivatives with higher added value to diversify revenue streams.

Summary

Market demand for DIBENIL is driven by pharmaceutical and dye manufacturing needs, with moderate growth expected over the next five years. Price increases are forecasted as supply chain constraints and environmental regulations tighten. Leading chemical producers continue expanding capacity, especially in Asia, while investing in greener technologies.

Key Takeaways

  • DIBENIL's primary use as an API intermediate sustains steady demand, with growth driven by pharmaceutical manufacturing expansion.
  • Price volatility results from raw material costs and regulatory pressures.
  • Asian markets will increasingly influence supply dynamics via capacity expansion.
  • Regulatory risks require ongoing monitoring, especially environmental restrictions.
  • Green synthesis methods present both risk and opportunity, influencing long-term market trajectory.

FAQs

1. What factors primarily influence DIBENIL pricing?
Raw material costs, supply chain stability, and regulatory regimes are key influences on DIBENIL pricing. Environmental restrictions can also impact manufacturing costs.

2. How is the demand for DIBENIL expected to evolve globally?
Demand is projected to grow at a CAGR of approximately 4%, driven by expansion in pharmaceutical active ingredient production and dye manufacturing across Asia, North America, and Europe.

3. What are the main risks facing DIBENIL market participants?
Risks include regulatory restrictions, environmental compliance costs, raw material price fluctuations, and supply chain disruptions.

4. Are greener synthesis methods impacting DIBENIL availability?
While emerging, greener processes are still at developmental stages; their impact on supply and costs remains limited but could influence future supply dynamics.

5. Which regions represent significant growth opportunities for DIBENIL players?
Asia-Pacific, especially China and India, offers growth opportunities due to expanding pharmaceutical industries and capacity investments.


References

[1] MarketWatch. (2023). Chemical price trends and projections.
[2] Industry Reports. (2022). Global pharmaceutical intermediate market analysis.
[3] US Environmental Protection Agency. (2021). Chemical substance regulations.
[4] OECD. (2021). Green chemistry initiatives and sustainable manufacturing practices.

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