You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

THIOTHIXENE HYDROCHLORIDE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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

Thiothixene hydrochloride is the generic ingredient in three branded drugs marketed by Pfizer, Alpharma Us Pharms, Paco, Teva, Teva Pharms, and Hikma, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for thiothixene hydrochloride.

Summary for THIOTHIXENE HYDROCHLORIDE
Recent Clinical Trials for THIOTHIXENE HYDROCHLORIDE

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

SponsorPhase
Lindner Center of HOPEPhase 2
Janssen Scientific Affairs, LLC
Canadian Institutes of Health Research (CIHR)

See all THIOTHIXENE HYDROCHLORIDE clinical trials

US Patents and Regulatory Information for THIOTHIXENE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Paco THIOTHIXENE HYDROCHLORIDE thiothixene hydrochloride CONCENTRATE;ORAL 071939-001 Dec 16, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva THIOTHIXENE HYDROCHLORIDE thiothixene hydrochloride CONCENTRATE;ORAL 071184-001 Jun 22, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pfizer NAVANE thiothixene hydrochloride CONCENTRATE;ORAL 016758-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma THIOTHIXENE HYDROCHLORIDE INTENSOL thiothixene hydrochloride CONCENTRATE;ORAL 073494-001 Jun 30, 1992 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pfizer NAVANE thiothixene hydrochloride INJECTABLE;INJECTION 016904-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Paco THIOTHIXENE HYDROCHLORIDE thiothixene hydrochloride CONCENTRATE;ORAL 071917-001 Sep 20, 1989 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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Thiothixene Hydrochloride

Introduction

Thiothixene hydrochloride, marketed under the brand name Navane, is a typical antipsychotic drug used to treat various psychiatric disorders, including schizophrenia, bipolar disorder, and behavioral disturbances. This article delves into the market dynamics and financial trajectory of thiothixene hydrochloride, providing insights into its market position, growth prospects, and financial performance.

Market Overview

The global antipsychotic drugs market, within which thiothixene hydrochloride operates, is expected to grow at a Compound Annual Growth Rate (CAGR) of around 2.5% over the next decade, reaching approximately $14.91 billion by 2025[1].

Growing Incidence of Mental Health Disorders

The increasing prevalence of mental health disorders such as schizophrenia, bipolar disorders, and unipolar depression drives the demand for antipsychotic drugs. Thiothixene hydrochloride, being an effective treatment for these conditions, benefits from this trend.

Technological Innovations

Recent technological developments in antipsychotic drugs, including improvements in drug delivery systems and the development of new generations of antipsychotics, influence the market dynamics. However, thiothixene hydrochloride, as a first-generation antipsychotic, must compete with newer, potentially more effective and safer alternatives[1].

Market Segmentation

By Application

Thiothixene hydrochloride is used in various psychiatric applications:

  • Schizophrenia: It is widely used to treat schizophrenia due to its efficacy in regulating behavior and thoughts.
  • Bipolar Disorders: The drug is also effective in managing bipolar disorders, particularly during manic episodes.
  • Other Applications: It is used for treating unipolar depression and behavioral disturbances[1][4].

By Class Type

Thiothixene hydrochloride falls under the first generation of antipsychotic drugs, which includes other drugs like haloperidol and chlorpromazine. Despite the advent of second and third-generation antipsychotics, first-generation drugs remain relevant due to their established efficacy and lower costs[1].

Financial Performance

Revenue and Market Size

The global antipsychotic drugs market, which includes thiothixene hydrochloride, is projected to reach $14.91 billion by 2025. While specific revenue figures for thiothixene hydrochloride are not readily available, its contribution to this overall market size is significant due to its long-standing presence and established patient base[1].

Cost and Utilization

Studies on Medicaid costs and utilization patterns indicate that antipsychotic drugs, including thiothixene hydrochloride, contribute substantially to mental health care expenditures. For instance, mental health carve-out drugs, which include antipsychotics, showed significant costs in various healthcare programs[2][3].

Key Players and Market Competition

Thiothixene hydrochloride is part of a competitive market dominated by major pharmaceutical companies:

  • Bristol-Myers Squibb Company: The manufacturer of Navane (thiothixene hydrochloride).
  • Pfizer, Inc.: A major player in the antipsychotic market with other drugs.
  • Glaxo SmithKline, Plc: Another significant player with a range of psychiatric medications.
  • Eli Lilly & Co.: Known for its extensive portfolio of psychiatric drugs[1].

Regional Market Dynamics

The market for thiothixene hydrochloride varies by region, with different regulatory environments and healthcare systems influencing its adoption and financial performance. The drug is widely used in regions with established healthcare systems where mental health treatment is more accessible[1].

Side Effects and Safety Concerns

While thiothixene hydrochloride is effective, it comes with a range of side effects, including weight gain, mental distress, and anticholinergic side effects like insomnia and dry mouth. These side effects can impact its market position, especially with the availability of newer drugs with better safety profiles[4][5].

Toxicology and Regulatory Considerations

Thiothixene hydrochloride has shown toxicity in animal studies, and there are anecdotal reports of liver damage in humans. However, the lack of comprehensive human studies makes it challenging to fully assess its long-term safety. Regulatory bodies closely monitor such drugs, and any adverse findings could impact their market trajectory[4][5].

Future Growth Opportunities

Despite the challenges, thiothixene hydrochloride remains a viable treatment option due to its established efficacy and lower costs compared to newer drugs. Future growth opportunities include:

  • Emerging Markets: Expanding into regions with growing healthcare needs and increasing awareness of mental health.
  • Generic Versions: The potential for generic versions to enter the market could increase accessibility and reduce costs, although this could also impact the revenue of the branded version.
  • Combination Therapies: Research into combination therapies that include thiothixene hydrochloride could enhance its market position by offering more comprehensive treatment options[1].

Key Takeaways

  • Thiothixene hydrochloride is a significant player in the global antipsychotic drugs market.
  • The drug benefits from the growing incidence of mental health disorders but faces competition from newer generations of antipsychotics.
  • Its financial performance is influenced by its widespread use and the overall growth of the antipsychotic market.
  • Side effects and safety concerns are critical factors that impact its market dynamics.
  • Future growth opportunities include expansion into emerging markets and potential generic versions.

FAQs

What is thiothixene hydrochloride used for?

Thiothixene hydrochloride, marketed under the brand name Navane, is used to treat various psychiatric disorders including schizophrenia, bipolar disorder, and behavioral disturbances.

What are the side effects of thiothixene hydrochloride?

Common side effects include weight gain, mental distress, insomnia, blurred vision, and dry mouth. Less frequently encountered side effects include drug-induced movement disorders like Parkinson's syndrome and tardive dyskinesia.

How does thiothixene hydrochloride compare to other antipsychotics?

Thiothixene hydrochloride is as effective as other antipsychotic drugs but may have a different side effect profile. It is a first-generation antipsychotic, which can be less expensive but may have more severe side effects compared to newer generations.

What is the market outlook for thiothixene hydrochloride?

The global antipsychotic drugs market, which includes thiothixene hydrochloride, is expected to grow at a CAGR of around 2.5% to reach approximately $14.91 billion by 2025.

Are there any safety concerns associated with thiothixene hydrochloride?

Yes, thiothixene hydrochloride has shown toxicity in animal studies and there are anecdotal reports of liver damage in humans. However, comprehensive human studies are lacking to fully assess its long-term safety.

Sources

  1. Research and Markets, "Global Antipsychotic Drugs Market Analysis & Trends - Industry Forecast to 2025"[1].
  2. Interact for Health, "FINAL REPORT Evaluation of Healthcare Costs and Utilization"[2].
  3. Oregon Drug Use Review / Pharmacy & Therapeutics Committee, "Patterns of changes in bipolar depressive symptoms revealed by trajectory analysis among ..."[3].
  4. Wikipedia, "Tiotixene"[4].
  5. FDA, "NAVANEĀ® (thiothixene) Label"[5].

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.