FLURAZEPAM HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for flurazepam hydrochloride and what is the scope of freedom to operate?

Flurazepam hydrochloride is the generic ingredient in two branded drugs marketed by Valeant Pharm Intl, Chartwell Rx, Halsey, Hikma Intl Pharms, Novitium Pharma, Purepac Pharm, Rising, Sun Pharm Industries, Superpharm, Usl Pharma, and Warner Chilcott, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for flurazepam hydrochloride. One supplier is listed for this compound.

Summary for FLURAZEPAM HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	23
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	4
What excipients (inactive ingredients) are in FLURAZEPAM HYDROCHLORIDE?	FLURAZEPAM HYDROCHLORIDE excipients list
DailyMed Link:	FLURAZEPAM HYDROCHLORIDE at DailyMed

Recent Clinical Trials for FLURAZEPAM HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Saint-Joseph University	Phase 3
Hannover Medical School	Phase 3
Eisai Inc.	Phase 1

See all FLURAZEPAM HYDROCHLORIDE clinical trials

Pharmacology for FLURAZEPAM HYDROCHLORIDE

Drug Class

Benzodiazepine

Medical Subject Heading (MeSH) Categories for FLURAZEPAM HYDROCHLORIDE

Anti-Anxiety Agents

GABA Modulators

Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for FLURAZEPAM HYDROCHLORIDE

N05CD	Benzodiazepine derivatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for FLURAZEPAM HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Superpharm	FLURAZEPAM HYDROCHLORIDE	flurazepam hydrochloride	CAPSULE;ORAL	071659-001	Aug 4, 1988		DISCN	No	No
Rising	FLURAZEPAM HYDROCHLORIDE	flurazepam hydrochloride	CAPSULE;ORAL	070345-001	Nov 27, 1985	AB	RX	No	Yes
Halsey	FLURAZEPAM HYDROCHLORIDE	flurazepam hydrochloride	CAPSULE;ORAL	071809-001	Jan 7, 1988		DISCN	No	No
Valeant Pharm Intl	DALMANE	flurazepam hydrochloride	CAPSULE;ORAL	016721-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for FLURAZEPAM HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharm Intl	DALMANE	flurazepam hydrochloride	CAPSULE;ORAL	016721-001	Approved Prior to Jan 1, 1982	4,316,897
Valeant Pharm Intl	DALMANE	flurazepam hydrochloride	CAPSULE;ORAL	016721-002	Approved Prior to Jan 1, 1982	4,316,897

Market Dynamics and Financial Trajectory for Flurazepam Hydrochloride

Last updated: February 13, 2026

Overview

Flurazepam hydrochloride, a benzodiazepine hypnotic, was introduced in the 1960s primarily for insomnia treatment. Its widespread use declined after the emergence of newer hypnotics and the increased awareness of dependency risks. While marketed globally in earlier decades, its presence in current pharmaceutical markets is limited, with production and prescribing mainly occurring in specific regions or for particular medical needs.

Market Landscape

• Global Market Size: The hypnotic drugs market, including benzodiazepines, was valued at approximately $4.2 billion in 2022, with benzodiazepines representing around 30-40%. Flurazepam's contribution has decreased significantly; it is no longer a leading product due to safety concerns.

• Key Competitors: Modern sleep aids, such as zolpidem, eszopiclone, and zaleplon, dominate the market. These drugs have more favorable safety profiles and less dependency potential.

• Prescribing Trends: Declining prescriptions for flurazepam reflect regulatory restrictions, updated clinical guidelines, and preference for newer drugs. Use persists primarily in specific markets with fewer regulations or in settings where old medications are still available.

• Regulatory Status: Many countries have restricted or withdrawn flurazepam from the market. In the United States, it is classified as a Schedule IV controlled substance but not actively marketed by major pharmaceutical companies. Some Asian and European countries still list it as approved for prescription.

Financial Trajectory

• Revenue Trends: Sales peaked in the 1970s and 1980s. Since then, revenues declined sharply due to safety concerns, leading to market withdrawals in several countries.

• Manufacturers: Original patent holders discontinued production. Existing stock is maintained mainly by generic manufacturers with minimal marketing efforts.

• Research and Development: No current R&D activities are directed toward flurazepam hydrochloride, as focus shifts to newer, safer compounds. Regulatory challenges and risk profiles deter investment.

• Pricing Dynamics: The drug exists mainly as a generic, with prices declining over time. In regions where it remains available, it is sold at low, often off-patent prices.

Regulatory and Legal Factors

• Agencies like the FDA and EMA classify flurazepam as a controlled substance due to dependency risks, resulting in strict prescribing controls.

• Several countries have banned or heavily restricted the drug, preventing any expansion.

• Post-market surveillance reports link long-term use to dependency and adverse effects, further limiting market potential.

Forecast

• The market for flurazepam hydrochloride is expected to decline further or stabilize at negligible levels, depending on regional regulations.

• In select markets, its market share may persist as a legacy drug, mainly for specific patient populations or in contexts where alternatives are limited.

• Investment in research or new formulations is unlikely owing to safety profiles, regulatory hurdles, and declining usage.

Key Factors Influencing Future Growth

Factor	Impact
Regulatory environment	Restricts or bans use, suppresses market growth
Competition from newer hypnotics	Outcompetes flurazepam on safety and efficacy
Prescriber preferences	Shift toward non-benzodiazepine sleep aids
Patent and manufacturing status	Limited or non-existent, suppressing profit margins

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Key Takeaways

• Flurazepam hydrochloride's market presence has diminished significantly since its peak usage in the 1970s and 1980s.

• Regulatory restrictions and safety concerns drive declining sales and market withdrawal in many countries.

• The current market is limited to legacy use, mainly by generic manufacturers, with minimal growth prospects.

• Future financial trajectory indicates continued decline or market stagnation, justified by safety profiles and evolving prescribing practices.

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FAQs

1. Is flurazepam hydrochloride still marketed?
   It remains available in some regions but is largely discontinued or restricted due to safety concerns.

2. What factors led to the decline of flurazepam?
   Safety issues such as dependency, overdose potential, and the development of safer sleep medications caused decline.

3. Are there ongoing clinical trials for flurazepam?
   No significant trials are active; research focus has shifted to newer hypnotics with improved safety profiles.

4. What are the main safety concerns associated with flurazepam?
   Dependency, withdrawal symptoms, cognitive impairment, and risk of overdose.

5. What is the future outlook for market revenues of flurazepam?
   Revenues are expected to decline further, with limited prospects for resurgence without new formulations or indications.

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References

[1] MarketWatch, "Global Sleep Aids Market Size, Share & Trends," 2022.
[2] US FDA, "Controlled Substance Schedules," 2023.
[3] European Medicines Agency, "Summary of Product Characteristics," 2022.
[4] Grand View Research, "Benzodiazepines Market Analysis," 2022.