Last Updated: May 10, 2026

CHLORDIAZACHEL Drug Patent Profile


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When do Chlordiazachel patents expire, and when can generic versions of Chlordiazachel launch?

Chlordiazachel is a drug marketed by Rachelle and is included in three NDAs.

The generic ingredient in CHLORDIAZACHEL is chlordiazepoxide hydrochloride. There are nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride profile page.

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  • What is the 5 year forecast for CHLORDIAZACHEL?
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  • What is Average Wholesale Price for CHLORDIAZACHEL?
Summary for CHLORDIAZACHEL

US Patents and Regulatory Information for CHLORDIAZACHEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rachelle CHLORDIAZACHEL chlordiazepoxide hydrochloride CAPSULE;ORAL 085086-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Rachelle CHLORDIAZACHEL chlordiazepoxide hydrochloride CAPSULE;ORAL 084639-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Rachelle CHLORDIAZACHEL chlordiazepoxide hydrochloride CAPSULE;ORAL 085087-001 Approved Prior to Jan 1, 1982 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 Chlordiazepoxide

Last updated: February 9, 2026

Overview

Chlordiazepoxide, a benzodiazepine developed in the 1960s, is primarily used for anxiety, alcohol withdrawal, and related conditions. It has a well-established history, but recent market shifts, patent considerations, and therapeutic competition influence its financial outlook.

Current Market Landscape

  • Product Status: Now a generic drug, Chlordiazepoxide faces typical generic market pressures. No recent patent protections; expiration occurred around the early 2000s.
  • Therapeutic Alternatives: Other benzodiazepines like diazepam, lorazepam, and alprazolam compete for market share.
  • Regulatory Environment: Increased focus on benzodiazepine misuse has led to tighter prescribing regulations in many regions, especially the US and Europe.

Market Size and Revenue Trends

Parameter Data Sources
Global benzodiazepine market value (2022) Estimated at $2 billion [1]
Chlordiazepoxide share in market (2022) Estimated below 5% due to generic status Market reports, blinded industry estimates
Revenue (2010-2022) Approximately stable at $50-$100 million annually, with slight decline Industry databases, IQVIA estimates
Manufacturing cost (per unit) Approx. $0.05 - $0.10 Generic manufacturer reports
Selling price (per unit) Approx. $0.20 - $0.50 Wholesale estimates

Market Drivers

  • Established Pharmacology: Its effectiveness for alcohol withdrawal syndromes and anxiety maintains steady demand, especially in institutional settings.
  • Cost Efficiency: Low manufacturing costs and widespread availability make it a preferred generic choice.
  • Regulatory Constraints: Stricter prescribing guidelines curb over-prescription, somewhat limiting growth.

Market Challenges

  • Generic Competition: Price erosion intensifies as multiple manufacturers produce identical formulations.
  • Therapeutic Competition: Newer drugs and non-Benzodiazepine options target similar conditions with improved safety profiles.
  • Regulatory Restrictions: Heightened controls threaten volume growth in some regions.
  • Legal and Safety Concerns: Increased litigation and concerns over dependency limits prescribing.

Financial Trajectory Analysis

  • Revenue Outlook (2023–2028):
    The market for Chlordiazepoxide is projected to decline at a compound annual growth rate (CAGR) of approximately -2% to -3%, driven by market saturation and competition. Wholesale revenues are expected to decrease from an estimated $70 million in 2022 to below $60 million by 2028.
  • Pricing Trends:
    Price compression is likely to persist. Firms may reduce wholesale prices to maintain market share; retail and hospital dispensing prices will follow suit.
  • Profitability Trends:
    Margins are stable or slightly declining due to generic price competition but remain attractive due to low manufacturing costs.

Regulatory and Future Market Factors

  • Potential Resurgence: Limited, unless new indications, formulations (e.g., sustained-release), or delivery mechanisms are introduced.
  • Market Consolidation: Larger pharmaceutical firms or generic manufacturers may seek to consolidate manufacturing capacities, impacting supply stability.
  • Patent and Exclusivity: No new patents are sought; thus, no exclusivity periods are expected, reinforcing generics' dominance.

Summary

Chlordiazepoxide remains a low-cost, widely used generic medication with declining revenues driven by generic market pressures and therapeutic competition. The drug's long history and established safety profile sustain its base demand, primarily through institutional sales. However, its growth prospects are limited. Financial performance will hinge on cost management and market share defense against competitors.


Key Takeaways

  • Chlordiazepoxide's revenue has been gradually declining due to generic competition and therapeutic alternatives.
  • Market dynamics favor low-cost generics with ongoing pressure on pricing.
  • Regulatory scrutiny limits prescribing, constraining growth.
  • Future revenue relies on maintenance of existing prescriptions rather than expansion.
  • Innovation or new indications are unlikely to alter its competitive position significantly.

FAQs

  1. What is the primary therapeutic use of Chlordiazepoxide?
    It treats anxiety, alcohol withdrawal, and certain agitation or psychomotor disorders.

  2. Has Chlordiazepoxide patent protection expired?
    Yes. The original patents expired in the early 2000s, leading to widespread generic manufacturing.

  3. What are the main competitors to Chlordiazepoxide?
    Diazepam, lorazepam, and alprazolam are common alternatives with similar indications.

  4. Is there potential for growth in Chlordiazepoxide markets?
    Limited. The drug’s market is mature and declining, with growth only possible through niche applications or formulations.

  5. What factors could influence future revenue trajectories?
    Regulatory changes, patent developments on competing drugs, and the emergence of new therapeutic options.


References

[1] MarketScan Reports, IQVIA, 2022.

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