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Last Updated: December 26, 2024

DALMANE Drug Patent Profile


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When do Dalmane patents expire, and what generic alternatives are available?

Dalmane is a drug marketed by Valeant Pharm Intl and is included in one NDA.

The generic ingredient in DALMANE is flurazepam hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the flurazepam hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dalmane

A generic version of DALMANE was approved as flurazepam hydrochloride by RISING on November 27th, 1985.

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Summary for DALMANE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 34
Patent Applications: 4,520
DailyMed Link:DALMANE at DailyMed
Drug patent expirations by year for DALMANE

US Patents and Regulatory Information for DALMANE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharm Intl DALMANE flurazepam hydrochloride CAPSULE;ORAL 016721-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Valeant Pharm Intl DALMANE flurazepam hydrochloride CAPSULE;ORAL 016721-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for DALMANE

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

DALMANE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dalmane

Introduction to Dalmane

Dalmane, known by its generic name flurazepam, is a hypnotic agent used primarily for the treatment of insomnia. It belongs to the class of benzodiazepines, which have seen a significant increase in prescriptions and misuse over the past few decades.

Market Overview of Benzodiazepines

The market for benzodiazepines, including Dalmane, has experienced substantial growth and challenges. From the mid-1990s to 2013, prescriptions for benzodiazepines in the United States increased by 67%, according to data from the American Journal of Public Health[1].

Prescription Trends and Misuse

The rise in benzodiazepine prescriptions has led to higher rates of misuse and abuse. The 2021 National Survey on Drug Use and Health reported that 1.4 million people aged 12 and older used sedatives, including benzodiazepines, and 3.9 million individuals acknowledged past-year benzodiazepine abuse[1].

Health Risks and Overdose Statistics

The misuse of benzodiazepines, including Dalmane, is associated with significant health risks. In 2021, there were over 12,000 overdose deaths involving benzodiazepines, highlighting the critical need for careful prescription and monitoring[1].

Pricing Dynamics of Brand-Name Drugs

Dalmane, as a brand-name drug, is subject to the pricing dynamics of the pharmaceutical market. Brand-name drugs often experience extraordinary price increases, with some drugs seeing price hikes of over 1,000% due to factors such as patent protection, market exclusivity, and consolidation among drug companies[4].

Extraordinary Price Increases

Between 2000 and 2008, the number of brand-name drug products with extraordinary price increases more than doubled. While most of these increases were less than 500%, some brand-name drugs saw price increases of over 1,000%, with the largest increase being around 4,200%[4].

Impact of Consolidation and Market Domination

The pharmaceutical industry has seen increased consolidation through mergers and acquisitions, leading to fewer companies producing and marketing drugs. This can result in greater market domination by certain companies and reduced competition, contributing to higher prices for drugs like Dalmane[4].

Cost-Benefit Analysis and Healthcare Utilization

Studies on healthcare costs and utilization, such as those involving school-based health centers, highlight the economic implications of prescription drug use. For instance, the costs associated with mental health services, hospitalizations, and prescription drugs can be significant, and programs aimed at reducing these costs often show mixed results[2].

Dosage and Administration Costs

The dosage and administration of Dalmane can impact its financial trajectory. The usual adult dosage is 30 mg before retiring, with 15 mg recommended for elderly or debilitated patients. The cost of these dosages, along with the frequency of use, contributes to the overall financial burden on patients and healthcare systems[3].

Contraindications and Safety Considerations

Dalmane is contraindicated in patients with known hypersensitivity to the drug and should be used cautiously in pregnancy due to potential fetal damage. These safety considerations can affect the market dynamics by limiting the patient population and necessitating careful medical supervision, which adds to the overall cost[3].

Treatment and Recovery Costs

The treatment of Dalmane addiction involves several steps, including detoxification, behavioral therapy, medication-assisted treatment, gradual tapering, and support groups. These comprehensive treatment programs are crucial but also add to the financial costs associated with managing benzodiazepine addiction[1].

Mental Health Impact and Treatment Costs

Dalmane withdrawal can significantly impact mental health, leading to symptoms such as anxiety, depression, and irritability. The treatment of these psychological effects, including therapy and support groups, is essential but incurs additional costs. These costs are part of the broader financial trajectory of managing benzodiazepine addiction[1].

Regulatory and Market Environment

The regulatory environment, including FDA approvals and patent protections, influences the pricing and availability of Dalmane. Changes in regulations or market conditions can affect the drug's financial trajectory by impacting production costs, competition, and consumer access[4].

Consumer Awareness and Market Discipline

Unlike other markets, the healthcare market often lacks the typical mechanisms of market discipline due to the influence of healthcare providers and third-party payers. This can lead to consumers being less aware of drug costs, which in turn affects the financial dynamics of drugs like Dalmane[4].

Key Takeaways

  • Market Growth: Benzodiazepine prescriptions, including Dalmane, have seen significant growth, contributing to higher rates of misuse and abuse.
  • Health Risks: Misuse of Dalmane is associated with substantial health risks, including overdose deaths.
  • Pricing Dynamics: Brand-name drugs like Dalmane can experience extraordinary price increases due to market and regulatory factors.
  • Treatment Costs: Comprehensive treatment programs for Dalmane addiction are costly but essential for recovery.
  • Regulatory Environment: FDA approvals, patent protections, and market conditions influence the financial trajectory of Dalmane.

FAQs

What is Dalmane used for?

Dalmane, or flurazepam, is used primarily for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakening[3].

What are the risks associated with Dalmane use?

Dalmane use is associated with risks such as addiction, increased tolerance, withdrawal symptoms, and significant mental health impacts including anxiety, depression, and irritability[1].

How does Dalmane affect mental health during withdrawal?

Dalmane withdrawal can significantly impact mental health, leading to symptoms such as anxiety, depression, irritability, and mood swings. Comprehensive treatment programs are crucial for managing these psychological effects[1].

What are the typical dosages of Dalmane?

The usual adult dosage of Dalmane is 30 mg before retiring, with 15 mg recommended for elderly or debilitated patients[3].

How does the pharmaceutical market influence the pricing of Dalmane?

The pricing of Dalmane is influenced by factors such as patent protection, market exclusivity, and consolidation among drug companies, which can lead to extraordinary price increases[4].

Sources

  1. Dalmane Addiction: Understanding and Recovery - The Grove Estate
  2. FINAL REPORT Evaluation of Healthcare Costs and Utilization - Interact for Health
  3. DALMANE - (flurazepam hydrochloride) - FDA
  4. GAO-10-201 Brand-Name Prescription Drug Pricing - GAO

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