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, 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:	12
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
Halsey	FLURAZEPAM HYDROCHLORIDE	flurazepam hydrochloride	CAPSULE;ORAL	071809-001	Jan 7, 1988		DISCN	No	No
Hikma	FLURAZEPAM HYDROCHLORIDE	flurazepam hydrochloride	CAPSULE;ORAL	071108-001	Dec 8, 1986		DISCN	No	No
Halsey	FLURAZEPAM HYDROCHLORIDE	flurazepam hydrochloride	CAPSULE;ORAL	071808-001	Jan 7, 1988		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
Valeant Pharm Intl	DALMANE	flurazepam hydrochloride	CAPSULE;ORAL	016721-002	Approved Prior to Jan 1, 1982

Market Dynamics and Financial Trajectory for Flurazepam Hydrochloride

Last updated: July 27, 2025

Introduction

Flurazepam Hydrochloride, a benzodiazepine derivative, has historically played a role in sleep disorder management, primarily insomnia. Its pharmacological profile includes sedative, anxiolytic, anticonvulsant, and muscle relaxant properties. Despite its longstanding presence, its market dynamics have been influenced by regulatory shifts, medical guidelines, and emerging alternative therapies. This report evaluates the current and projected financial trajectory of Flurazepam Hydrochloride within global pharmaceutical markets, emphasizing demand, competitive landscape, regulatory considerations, and potential growth opportunities.

Market Overview

Historical Context and Current Use

Developed in the 1960s, Flurazepam was among the first benzodiazepines approved for sleep disorders [1]. Its efficacy in inducing and maintaining sleep contributed to widespread use across North America, Europe, and parts of Asia. However, concerns regarding tolerance, dependence, and adverse effects prompted regulatory agencies such as the FDA to impose restrictions or reclassify benzodiazepines, including Flurazepam.

Currently, Flurazepam's use is predominantly confined to specific clinical scenarios, often as a second-line agent or where other sedatives are contraindicated. Its prescription volume has declined markedly over the past decade, replaced largely by newer hypnotics like non-benzodiazepine sleep aids (e.g., zolpidem, zaleplon) [2].

Market Size and Revenue Potential

As per recent estimates, the global hypnotic and sedative drugs market was valued at approximately USD 4.5 billion in 2022, with benzodiazepines constituting roughly 40% of this segment—though Flurazepam's share is minimal, owing to declining use [3].

The shrinking market volume constrains revenue prospects for Flurazepam-focused manufacturing. Nonetheless, niche markets, orphan drug status, or legacy formulations in certain geographies may sustain modest revenues.

Market Drivers

Medical Demand

Despite evolving prescribing patterns, Flurazepam retains niche utility, particularly in cases resistant to newer agents or where sedative-hypnotic options are limited. Certain regions with limited access to newer drugs or with longstanding healthcare practices might sustain its use.

Regulatory Environment

Stringent regulations have restricted benzodiazepine prescriptions due to abuse potential. In markets with strict controls—such as the US or EU—prescription volumes are limited. Conversely, countries with less restrictive policies or unique prescribing habits might see stable or marginally increasing demand [4].

Patent and Formulation Stability

Flurazepam is a generic compound without recent patent protections, limiting investment incentives. However, formulations with extended-release or combination therapies could offer niche opportunities, particularly in markets emphasizing tailored sleep disorder treatments.

Off-Label or Investigational Uses

Although primarily approved for insomnia, research exploring benzodiazepine derivatives’ roles in other conditions could influence future demand. However, current evidence for Flurazepam's off-label applications is limited.

Market Challenges

Safety and Dependence Risks

The primary obstacle to commercial growth remains its dependency risk profile, leading to potential misuse and regulatory crackdowns. This stigmatization reduces prescriber willingness and pharmaceutical manufacturer interest.

Competition from Safer Alternatives

Non-benzodiazepine hypnotics—like zolpidem, eszopiclone, and ramelteon—offer improved safety profiles, with fewer withdrawal issues, disinhibition, or rebound insomnia, further limiting Flurazepam market share [5].

Regulatory Restrictions and Stigmatization

Nation-specific regulatory constraints curtail access and prescription privileges, impacting market penetration and financial outlooks.

Future Financial Trajectory

Market Forecasts (2023-2030)

Given current trends, the global market for traditional benzodiazepines—including Flurazepam—is expected to decline by approximately 3-5% annually, driven by increasing regulation and shifting prescriber preferences. Nevertheless, niche markets—such as in regions with less restrictive policies—may retain marginal growth, estimated at 1-2% annually.

Innovative Opportunities

Potential avenues for stabilizing or augmenting revenues include:

• Regulatory Resurgence: In countries where regulatory barriers ease, Flurazepam could see limited renewal in clinical use.
• Formulation Innovations: Extended-release versions or combination therapies targeting specific patient populations might create niche segments.
• Generic Market Selling: As patents expire, manufacturers could focus on cost-effective generic production, maintaining modest revenues in legacy markets.

Investment Considerations

Pharmaceutical firms should evaluate the cost-benefit ratio of continued production. The declining demand, compounded with safety concerns, suggests limited lucrative opportunities unless specific niche or regulatory-driven opportunities arise.

Regulatory and Societal Considerations

Regulatory agencies globally are emphasizing abuse-deterrent formulations and tighter controls of benzodiazepines. Ongoing legal and societal pressures to curb prescription misuse will likely restrict Flurazepam's market size further. Moreover, increased awareness of dependence issues among patients influences physician prescribing habits.

Conclusion

The financial outlook for Flurazepam Hydrochloride remains subdued owing to evolving medical paradigms, stringent regulations, and fierce competition from safer alternatives. While niche markets may sustain minimal revenues, the broader trend indicates a continued decline. Pharmaceutical companies should carefully weigh investment in legacy benzodiazepine formulations against emerging therapeutic options.

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Key Takeaways

• Declining Market: Flurazepam Hydrochloride’s global demand has substantially decreased, aligning with its operational risk profile and regulatory restrictions.
• Niche Opportunities: Limited to regions with lax regulations or specific clinical needs, leading to marginal revenue preservation.
• Competitive Displacement: Safer, more effective sleep aids continue to replace benzodiazepines, intensifying market contraction.
• Regulatory Risks: Future growth is unlikely absent regulatory relaxations; ongoing drug safety concerns pose a significant barrier.
• Focus on Innovation or Legacy Markets: Firms should explore niche formulations or consider exiting the market to reallocate resources efficiently.

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FAQs

1. Is Flurazepam Hydrochloride still approved for clinical use globally?
Approval status varies: While it remains prescribed in some regions under specific guidelines, many countries have restricted or discontinued its use due to safety and dependency concerns.

2. What are the main safety concerns associated with Flurazepam?
Risks include dependence, tolerance development, cognitive impairment, and potential for abuse, contributing to regulatory restrictions.

3. Can Flurazepam be used for disorders other than insomnia?
Primarily approved for sleep disorders, but off-label use is limited and not widely endorsed due to safety issues. Research into other applications is minimal.

4. Is there significant R&D activity around Flurazepam or benzodiazepine derivatives?
Recent R&D efforts are focused on developing safer sleep aids, often avoiding traditional benzodiazepines, including Flurazepam derivatives.

5. What are the prospects for generic manufacturers of Flurazepam?
Generics can maintain modest revenues, especially in markets with limited regulatory enforcement or existing stocking processes. However, long-term prospects are hampered by declining demand.

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References

[1] European Medicines Agency (EMA). Benzodiazepines: Overview and Safety Concerns.
[2] IMS Health Data. Trends in sleeping disorder medication usage.
[3] Market Research Future. Global Hypnotics and Sedatives Market Report, 2022.
[4] Food and Drug Administration (FDA). Benzodiazepine prescribing guidelines.
[5] National Center for Complementary and Integrative Health. Safety of Sleep Aids.