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, Esjay Pharma, Halsey, Hikma, Hikma Intl Pharms, 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
Patent Applications:	1,332
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
Warner Chilcott	FLURAZEPAM HYDROCHLORIDE	flurazepam hydrochloride	CAPSULE;ORAL	071768-001	Dec 4, 1987		DISCN	No	No
Superpharm	FLURAZEPAM HYDROCHLORIDE	flurazepam hydrochloride	CAPSULE;ORAL	071659-001	Aug 4, 1988		DISCN	No	No
Rising	FLURAZEPAM HYDROCHLORIDE	flurazepam hydrochloride	CAPSULE;ORAL	071717-001	Jul 31, 1991		DISCN	No	No
Chartwell Rx	FLURAZEPAM HYDROCHLORIDE	flurazepam hydrochloride	CAPSULE;ORAL	072368-001	Mar 30, 1989	AB	RX	No	No
Esjay Pharma	FLURAZEPAM HYDROCHLORIDE	flurazepam hydrochloride	CAPSULE;ORAL	070445-001	Mar 20, 1986		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

FLURAZEPAM HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Flurazepam Hydrochloride

Introduction

Flurazepam hydrochloride, marketed under the brand name Dalmane, is a benzodiazepine derivative used as a hypnotic agent to treat insomnia. Understanding its market dynamics and financial trajectory is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Demand and Indications

Flurazepam hydrochloride is indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakening. The demand for this drug is driven by the prevalence of insomnia, which is a common sleep disorder affecting a significant portion of the population[5].

Competitive Landscape

In the hypnotic drug market, flurazepam hydrochloride competes with other benzodiazepines and non-benzodiazepine hypnotics. Its unique pharmacokinetic profile, which includes a relatively minor effect on REM sleep and a lower risk of drug dependence, gives it an edge over some competitors[1][3].

Pharmacokinetics and Efficacy

The drug's rapid absorption from the gastrointestinal tract and its active metabolites contribute to its efficacy. The major metabolite, N1-desalkyl-flurazepam, has a half-life ranging from 47 to 100 hours, which may explain its increasing effectiveness on consecutive nights of use[2][5].

Patient Demographics

Flurazepam hydrochloride is used across various age groups, but its pharmacokinetics vary significantly in elderly patients. Elderly male subjects have a longer elimination half-life for the major metabolite, which can influence dosing strategies[2][5].

Pricing and Cost

The cost of flurazepam hydrochloride varies depending on the dosage and the manufacturer. For example, the cost of a 30 mg capsule can range from $0.34 to $2.01 USD, making it a relatively affordable option for insomnia treatment[3].

Prescription Trends

While specific data on flurazepam hydrochloride prescription trends is not readily available, the broader trend in hypnotic prescriptions suggests a steady demand. The use of hypnotics can be influenced by factors such as changes in healthcare policies and the COVID-19 pandemic, which have impacted prescription patterns for controlled substances[4].

Regulatory Environment

Flurazepam hydrochloride is a controlled substance due to its potential for abuse, although it is considered to have a lower risk compared to other benzodiazepines. Regulatory oversight and guidelines on its use, particularly in elderly and debilitated patients, are crucial for its market dynamics[2][5].

Financial Performance

The financial performance of flurazepam hydrochloride is influenced by several factors, including market demand, competition, and regulatory environment. While exact financial figures are not provided in the available sources, the drug's efficacy and relatively low cost contribute to its stable market presence.

Geriatric Market

The geriatric population is a significant market segment for flurazepam hydrochloride. Given the longer elimination half-life of its major metabolite in elderly patients, this demographic requires careful dosing adjustments. This segment is growing, and the drug's suitability for this age group can impact its financial trajectory positively[2][5].

Adverse Effects and Safety Profile

The safety profile of flurazepam hydrochloride, including its potential for adverse effects such as staggering, falling, and increased risk of seizures in certain conditions, affects its market dynamics. However, its overall safety profile is considered favorable compared to other hypnotics[2][5].

Clinical Studies and Evidence

Clinical studies have objectively determined the efficacy of flurazepam hydrochloride for at least 28 consecutive nights. This evidence supports its continued use and market presence, despite the general caution against prolonged use of hypnotics[5].

Key Takeaways

• Market Demand: Driven by the prevalence of insomnia.
• Competitive Edge: Unique pharmacokinetic profile with minor effects on REM sleep.
• Pricing: Relatively affordable compared to other hypnotics.
• Regulatory Environment: Controlled substance with specific guidelines for use.
• Geriatric Market: Significant segment requiring careful dosing adjustments.
• Safety Profile: Favorable but with potential adverse effects.

FAQs

Q: What is flurazepam hydrochloride used for? A: Flurazepam hydrochloride is used for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakening.

Q: How is flurazepam hydrochloride metabolized? A: Flurazepam hydrochloride is rapidly metabolized, and its major metabolite, N1-desalkyl-flurazepam, has a half-life ranging from 47 to 100 hours.

Q: What are the potential adverse effects of flurazepam hydrochloride? A: Potential adverse effects include staggering, falling, and an increased risk of seizures in certain conditions.

Q: Is flurazepam hydrochloride suitable for elderly patients? A: Yes, but it requires careful dosing adjustments due to the longer elimination half-life of its major metabolite in elderly patients.

Q: How does the cost of flurazepam hydrochloride compare to other hypnotics? A: Flurazepam hydrochloride is relatively affordable, with costs ranging from $0.34 to $2.01 USD per capsule.

Cited Sources

1. PubMed: Flurazepam hydrochloride, a benzodiazepine hypnotic.
2. FDA Label: DALMANE (flurazepam hydrochloride).
3. DrugBank: Flurazepam: Uses, Interactions, Mechanism of Action.
4. DEA Diversion: IQVIA Report on Stimulant Trends from 2012 - 2022.
5. DailyMed: FLURAZEPAM HYDROCHLORIDE capsule.