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Last Updated: December 22, 2024

Thioridazine - Generic Drug Details


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What are the generic drug sources for thioridazine and what is the scope of patent protection?

Thioridazine is the generic ingredient in four branded drugs marketed by Novartis, Actavis Mid Atlantic, Alpharma Us Pharms, Ani Pharms, Epic Pharma Llc, Pharm Assoc, Sandoz, Wockhardt, Roxane, Chartwell Rx, Heritage Pharma Avet, Mutual Pharm, Mylan, Par Pharm, Sun Pharm Industries, Superpharm, Watson Labs, Watson Labs Teva, and West Ward, and is included in eighty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for thioridazine.

Drug Prices for thioridazine

See drug prices for thioridazine

Recent Clinical Trials for thioridazine

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

SponsorPhase
Rabin Medical CenterEarly Phase 1
Rambam Health Care CampusEarly Phase 1
State University of New York at BuffaloPhase 4

See all thioridazine clinical trials

Medical Subject Heading (MeSH) Categories for thioridazine
Anatomical Therapeutic Chemical (ATC) Classes for thioridazine

US Patents and Regulatory Information for thioridazine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wockhardt THIORIDAZINE HYDROCHLORIDE thioridazine hydrochloride CONCENTRATE;ORAL 088258-001 Jul 25, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs Teva THIORIDAZINE HYDROCHLORIDE thioridazine hydrochloride TABLET;ORAL 088567-001 May 11, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Industries THIORIDAZINE HYDROCHLORIDE thioridazine hydrochloride TABLET;ORAL 089953-001 Oct 7, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Roxane THIORIDAZINE HYDROCHLORIDE thioridazine hydrochloride TABLET;ORAL 088665-001 Mar 15, 1984 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

Thioridazine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Thioridazine

Introduction to Thioridazine

Thioridazine, a dopamine receptor D2 (DRD2) antagonist, has been historically used as an antipsychotic medication, particularly for treating schizophrenia and other related psychiatric disorders. However, its use has expanded into other therapeutic areas, including oncology, which has significant implications for its market dynamics and financial trajectory.

Historical Market Overview

Thioridazine was once a prominent player in the central nervous system (CNS) drug market, which is one of the most profitable sectors in the pharmaceutical industry. In the early 2000s, CNS drugs, including antipsychotics like thioridazine, accounted for annual US sales exceeding $17 billion[3].

Market Size and Growth

The global thioridazine hydrochloride market has experienced fluctuations over the years. As of 2018, the market size was valued at several million USD, with a compound annual growth rate (CAGR) from 2014 to 2018. It is projected to continue growing, reaching a significant value by 2024, although the exact figures are not disclosed[1][4].

Market Segmentation

The thioridazine market can be segmented into several key areas:

Types of Thioridazine

The market is categorized based on different types of thioridazine hydrochloride products. These types vary in formulation and dosage, which can influence market demand and pricing[1][4].

Applications of Thioridazine

Thioridazine is used in various applications:

  • Antipsychotic Use: Traditionally, it has been used to treat schizophrenia and other psychiatric disorders.
  • Oncology: Recent studies have explored its potential in treating acute myeloid leukemia (AML) and myelodysplastic syndrome, particularly in older patients where traditional chemotherapies are less effective[2].

Geographic Regions

The market is analyzed across different regions, including North America, Europe, China, Japan, Middle East & Africa, and South America. Each region has its own demand patterns, regulatory environments, and competitive landscapes[1][4].

Financial Trajectory

Revenue Trends

The revenue of thioridazine hydrochloride has shown a steady growth from 2014 to 2018 and is expected to continue this trend until 2024. The CAGR during this period indicates a stable and growing market[1][4].

Regional Performance

  • North America: This region has been a significant contributor to the global market due to high healthcare spending and advanced medical research.
  • Europe: Europe also plays a crucial role, with countries like Germany, France, and the UK driving demand.
  • Asia & Pacific: Countries such as China, Japan, and India are emerging as key markets due to growing healthcare needs and increasing investment in pharmaceutical research[1][4].

Competitive Landscape

The thioridazine market is characterized by a mix of established pharmaceutical companies and newer entrants. The competitive landscape is influenced by factors such as product differentiation, pricing strategies, and regulatory approvals.

Regulatory and Safety Considerations

Thioridazine has faced regulatory scrutiny due to its side effects, particularly when used as an antipsychotic. However, its potential in oncology has led to renewed interest and clinical trials. For instance, a phase 1 trial evaluating thioridazine in combination with cytarabine for AML patients showed promising results in terms of safety and efficacy[2].

Future Outlook

Oncology Applications

The future of thioridazine is increasingly tied to its potential in treating AML and other hematological malignancies. Clinical trials have shown that thioridazine can be safely combined with cytarabine and may offer a new therapeutic option for older patients with limited treatment choices[2].

Market Expansion

As the global healthcare landscape evolves, the demand for thioridazine is expected to grow, driven by increasing awareness of its antileukemic properties and the need for novel therapeutic strategies in oncology.

Challenges and Opportunities

Challenges

  • Side Effects: Thioridazine's use is associated with side effects such as QTc prolongation, which can limit its adoption in certain patient populations.
  • Regulatory Hurdles: The drug must navigate stringent regulatory approvals, especially when transitioning from psychiatric to oncologic use.

Opportunities

  • Diversified Applications: The expansion into oncology opens new revenue streams and market opportunities.
  • Research and Development: Continued research into thioridazine's antileukemic properties could lead to new formulations and dosages, further enhancing its market position.

Key Takeaways

  • Thioridazine's market is growing, driven by its traditional use in psychiatry and emerging applications in oncology.
  • The drug's financial trajectory is positive, with a projected increase in revenue by 2024.
  • Regional markets, particularly North America and Europe, are significant contributors to the global market.
  • Regulatory and safety considerations remain crucial, but ongoing clinical trials suggest a promising future in treating AML.

FAQs

Q1: What is thioridazine traditionally used for? Thioridazine is traditionally used as an antipsychotic medication to treat schizophrenia and other related psychiatric disorders.

Q2: What are the emerging applications of thioridazine? Thioridazine is being explored for its potential in treating acute myeloid leukemia (AML) and myelodysplastic syndrome, particularly in older patients.

Q3: What are the key regions driving the thioridazine market? The key regions driving the thioridazine market include North America, Europe, China, Japan, Middle East & Africa, and South America.

Q4: What are the challenges associated with thioridazine's use? Thioridazine's use is associated with side effects such as QTc prolongation, and it must navigate stringent regulatory approvals.

Q5: What is the projected growth of the thioridazine market? The thioridazine market is expected to grow, with a positive CAGR from 2019 to 2024, driven by its traditional and emerging applications.

Sources

  1. Global Thioridazine Hydrochloride Industry Market Report 2019 - Maia Research
  2. A phase 1 trial evaluating thioridazine in combination with cytarabine - Blood Advances
  3. PERSPECTIVES on CNS drug market - Nature Publishing Group
  4. Global Thioridazine hydrochloride Market Report 2019 - Report Ocean

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