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Last Updated: December 22, 2024

THIOTHIXENE HYDROCHLORIDE INTENSOL Drug Patent Profile


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When do Thiothixene Hydrochloride Intensol patents expire, and what generic alternatives are available?

Thiothixene Hydrochloride Intensol is a drug marketed by Hikma and is included in one NDA.

The generic ingredient in THIOTHIXENE HYDROCHLORIDE INTENSOL is thiothixene hydrochloride. There are six drug master file entries for this compound. Additional details are available on the thiothixene hydrochloride profile page.

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Summary for THIOTHIXENE HYDROCHLORIDE INTENSOL
Drug patent expirations by year for THIOTHIXENE HYDROCHLORIDE INTENSOL

US Patents and Regulatory Information for THIOTHIXENE HYDROCHLORIDE INTENSOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma THIOTHIXENE HYDROCHLORIDE INTENSOL thiothixene hydrochloride CONCENTRATE;ORAL 073494-001 Jun 30, 1992 DISCN No 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

THIOTHIXENE HYDROCHLORIDE INTENSOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Thiothixene Hydrochloride Intensol

Introduction

Thiothixene Hydrochloride Intensol, a concentrated oral solution of the antipsychotic drug thiothixene, is used primarily for the management of schizophrenia. Understanding the market dynamics and financial trajectory of this drug involves analyzing various factors, including its clinical use, market competition, pricing, and regulatory environment.

Clinical Use and Indications

Thiothixene is indicated for the treatment of schizophrenia, a chronic and severe mental disorder. It acts as an antagonist on various receptors, including dopaminergic, serotonergic, histaminergic, and muscarinic receptors, which helps in managing both productive and unproductive symptoms of schizophrenia[2][5].

Market Competition

The antipsychotic market is highly competitive, with several drugs available for the treatment of schizophrenia. Thiothixene competes with other typical antipsychotics like haloperidol and chlorpromazine, as well as atypical antipsychotics such as risperidone and olanzapine. The competition can impact pricing and market share, as healthcare providers and patients often have multiple treatment options.

Pricing and Cost Analysis

The pricing of thiothixene can vary based on the formulation and dosage. For instance, the cost of thiothixene capsules ranges from approximately $0.31 for a 2 mg capsule to $0.67 for a 10 mg capsule[2].

Cost Comparison

  • Thiothixene 10 mg capsule: $0.67
  • Thiothixene 5 mg capsule: $0.47
  • Thiothixene 2 mg capsule: $0.31
  • Thiothixene 1 mg capsule: $0.24

This pricing makes thiothixene a relatively affordable option compared to some of the newer atypical antipsychotics.

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of any pharmaceutical drug. Thiothixene, being an approved drug, must comply with various regulatory requirements, including those related to manufacturing, labeling, and post-marketing surveillance. Any changes in regulatory policies or the introduction of new guidelines can affect the drug's market dynamics.

Reimbursement and Insurance Coverage

Reimbursement policies by insurance providers and government programs significantly influence the financial performance of pharmaceuticals. Thiothixene, being a generic drug, is often covered by various insurance plans, including Medicaid and Medicare. However, the extent of coverage can vary, and changes in reimbursement rates can impact the drug's financial trajectory[4].

Patient Compliance and Adherence

Patient compliance and adherence to treatment are critical factors in the long-term financial success of any medication. Thiothixene, like other antipsychotics, requires regular monitoring and follow-up visits to ensure that the medication is working properly and to manage potential side effects. Non-compliance can lead to increased healthcare costs due to hospitalizations and emergency department visits[5].

Side Effects and Safety Profile

The safety profile of thiothixene includes potential side effects such as tardive dyskinesia, neuroleptic malignant syndrome, and various anticholinergic symptoms. These side effects can impact patient compliance and may lead to additional healthcare costs for managing these conditions. Regular monitoring by healthcare providers is essential to mitigate these risks[5].

Market Trends and Forecast

The antipsychotic market is expected to grow due to increasing prevalence of mental health disorders and advancements in treatment options. However, the generic nature of thiothixene means that its market share may be influenced by the availability of other generic and branded antipsychotics.

Growth Drivers

  • Increasing Prevalence of Schizophrenia: The growing number of patients diagnosed with schizophrenia is a key driver for the antipsychotic market.
  • Advancements in Treatment: Continuous research and development in antipsychotic medications can lead to better treatment outcomes and increased demand.

Growth Constraints

  • Generic Competition: The presence of multiple generic antipsychotics can reduce the market share of thiothixene.
  • Side Effects and Safety Concerns: The potential for serious side effects can impact patient compliance and preference for other treatment options.

Financial Trajectory

The financial trajectory of thiothixene is influenced by its pricing, market competition, and regulatory environment. Here are some key financial aspects:

Revenue Streams

  • Prescription Sales: The primary revenue stream for thiothixene comes from prescription sales.
  • Government Programs: Reimbursement from government programs such as Medicaid and Medicare contributes significantly to the revenue.

Cost Structure

  • Manufacturing Costs: The cost of producing thiothixene, including raw materials and manufacturing processes.
  • Marketing and Distribution: Costs associated with marketing, distribution, and sales efforts.
  • Regulatory Compliance: Costs related to complying with regulatory requirements.

Profit Margins

The profit margins for thiothixene can be influenced by the competitive pricing in the generic market. While it is a cost-effective option, the profit margins may be lower compared to branded antipsychotics.

Case Studies and Real-World Data

Studies like the one on School-Based Health Centers (SBHCs) highlight the importance of integrated healthcare services, which can include antipsychotic medications like thiothixene. These studies often analyze the cost-benefit analysis and the impact on healthcare utilization and costs[1].

"A repeated-measure analysis of covariance (ANCOVA) assessed the effect of the SBHC program on students’ total Medicaid costs, costs of hospitalization, and ED visits. The study found significant reductions in healthcare costs and utilization for students with mental health problems, including those treated with antipsychotic medications"[1].

Key Takeaways

  • Clinical Use: Thiothixene is primarily used for treating schizophrenia.
  • Market Competition: The drug competes with other antipsychotics in a highly competitive market.
  • Pricing: Thiothixene is relatively affordable compared to some atypical antipsychotics.
  • Regulatory Environment: Compliance with regulatory requirements is crucial.
  • Reimbursement and Insurance: Coverage by insurance plans affects its financial performance.
  • Patient Compliance: Regular monitoring is necessary to manage side effects and ensure compliance.
  • Market Trends: The antipsychotic market is expected to grow, but generic competition is a constraint.

FAQs

Q1: What is Thiothixene Hydrochloride Intensol used for?

Thiothixene Hydrochloride Intensol is used for the treatment of schizophrenia.

Q2: How does Thiothixene compare to other antipsychotics in terms of pricing?

Thiothixene is generally more affordable than many atypical antipsychotics but competes with other generic typical antipsychotics.

Q3: What are the common side effects of Thiothixene?

Common side effects include tardive dyskinesia, neuroleptic malignant syndrome, and various anticholinergic symptoms.

Q4: How does the regulatory environment impact Thiothixene?

The regulatory environment affects the manufacturing, labeling, and post-marketing surveillance of Thiothixene, influencing its market dynamics.

Q5: What role does patient compliance play in the financial trajectory of Thiothixene?

Patient compliance is crucial as non-compliance can lead to increased healthcare costs due to hospitalizations and emergency department visits.

Sources

  1. FINAL REPORT Evaluation of Healthcare Costs and Utilization: Interact for Health.
  2. Thiothixene: Uses, Interactions, Mechanism of Action: DrugBank.
  3. Request approval to adopt the Public Health Laboratory fee schedule: Los Angeles County Department of Health Services.
  4. #33 October 14, 2014 - Lacounty: Los Angeles County.
  5. Thiothixene (oral route): Mayo Clinic.

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