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Last Updated: December 22, 2024

MELLARIL Drug Patent Profile


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Which patents cover Mellaril, and when can generic versions of Mellaril launch?

Mellaril is a drug marketed by Novartis and is included in two NDAs.

The generic ingredient in MELLARIL is thioridazine. There are eighteen drug master file entries for this compound. Additional details are available on the thioridazine profile page.

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Summary for MELLARIL
Drug patent expirations by year for MELLARIL
Recent Clinical Trials for MELLARIL

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SponsorPhase
New Mexico Cancer Care AllianceEarly Phase 1
Oxnard FoundationEarly Phase 1

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US Patents and Regulatory Information for MELLARIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis MELLARIL thioridazine hydrochloride CONCENTRATE;ORAL 011808-012 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis MELLARIL thioridazine hydrochloride TABLET;ORAL 011808-009 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis MELLARIL thioridazine hydrochloride TABLET;ORAL 011808-016 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis MELLARIL thioridazine hydrochloride TABLET;ORAL 011808-017 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis MELLARIL thioridazine hydrochloride CONCENTRATE;ORAL 011808-018 Approved Prior to Jan 1, 1982 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

MELLARIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mellaril (Thioridazine HCl)

Market Overview

Mellaril, also known as Thioridazine HCl, is an antipsychotic medication belonging to the phenothiazine class. It is primarily used to treat psychotic disorders, particularly schizophrenia, in patients who have not responded adequately to other antipsychotic drugs.

Historical Context and Market Position

Introduction and Early Use

Mellaril was introduced in the 1950s and was one of the first-generation antipsychotic drugs. Initially, it was widely used for treating schizophrenia and other psychotic disorders due to its efficacy in managing symptoms such as hallucinations and delusions.

Market Trends

Over the years, the market for antipsychotic drugs has evolved significantly. The global antipsychotic drugs market, which includes Mellaril, has seen a steady growth rate. According to market analyses, the global antipsychotic drugs market was projected to grow at a CAGR of around 2.5% from 2017 to 2025, reaching approximately $14.91 billion by 2025[1].

Financial Trajectory

Revenue and Growth

The financial performance of Mellaril is closely tied to the broader antipsychotic drugs market. While specific revenue figures for Mellaril are not readily available, the drug's sales have been influenced by several factors:

  • Generic Competition: The introduction of generic versions of antipsychotic drugs has significantly impacted the market. Generic drugs have reduced the unit costs and contributed to a decline in overall trend for brand-name drugs. This trend has been observed since the early 2000s, with unit-cost growth declining from 8.3% in 2002 to 2.7% in 2005[3].
  • Utilization and Unit Costs: The utilization of antipsychotic drugs, including Mellaril, has shown variability. However, the overall trend has been downward due to increased use of generic drugs and better management of prescription drug benefits. In 2005, the average cost of prescription drug benefits rose only 5.4%, which was well below the 8.5% increase in 2004[3].

Challenges and Limitations

Safety Concerns

Mellaril has faced significant challenges due to its safety profile. The drug is associated with a dose-related prolongation of the QTc interval, which can lead to potentially life-threatening arrhythmias such as Torsades de Pointes. This has limited its use to patients who have failed to respond to other antipsychotic drugs due to insufficient effectiveness or intolerable adverse effects[4].

Regulatory and Clinical Implications

The safety concerns have led to strict guidelines for its use. Mellaril should only be used after at least two trials with different antipsychotic drugs have failed, and the dosage must be individualized to the smallest effective dose. These restrictions have impacted its market share and financial performance.

Market Dynamics

Competitive Landscape

The antipsychotic drugs market is highly competitive, with several first-generation, second-generation, and third-generation drugs available. Mellaril competes with other first-generation antipsychotics like Haloperidol (Haldo) and Chlorpromazine (Thorazine), as well as newer second-generation and third-generation drugs like Risperdal (Risperidone) and Abilify (Aripiprazole)[1].

Technological and Therapeutic Advancements

Recent technological developments and the introduction of newer antipsychotic drugs have shifted the market dynamics. Newer drugs often offer superior efficacy, safety, or convenience, which has led to a decline in the use of older drugs like Mellaril.

Future Outlook

Market Projections

Given the safety concerns and the availability of newer, safer alternatives, the market share of Mellaril is expected to continue declining. The global antipsychotic drugs market will likely be driven by newer therapeutic classes and advancements in treatment options.

Investment and Growth Opportunities

Investors and pharmaceutical companies are more likely to focus on developing and marketing newer antipsychotic drugs with better safety profiles and efficacy. This shift will continue to impact the financial trajectory of older drugs like Mellaril.

Key Takeaways

  • Market Growth: The global antipsychotic drugs market is growing, but Mellaril's share is declining due to safety concerns and competition from newer drugs.
  • Financial Performance: The revenue from Mellaril has been impacted by generic competition, safety concerns, and the introduction of newer therapeutic options.
  • Safety Profile: Mellaril's use is restricted due to its potential for life-threatening side effects, limiting its market and financial potential.
  • Competitive Landscape: The market is highly competitive, with newer drugs offering superior safety and efficacy profiles.

FAQs

Q: What is Mellaril used for? A: Mellaril (Thioridazine HCl) is used to treat psychotic disorders, particularly schizophrenia, in patients who have not responded adequately to other antipsychotic drugs.

Q: Why is the use of Mellaril restricted? A: Mellaril is restricted due to its potential for significant, possibly life-threatening, proarrhythmic effects, such as prolonging the QTc interval.

Q: How does Mellaril compare to other antipsychotic drugs in terms of safety? A: Mellaril has a poorer safety profile compared to newer antipsychotic drugs, which has led to its limited use and declining market share.

Q: What are the key factors affecting the financial performance of Mellaril? A: The financial performance of Mellaril is affected by generic competition, safety concerns, and the introduction of newer therapeutic options.

Q: What is the future outlook for Mellaril in the antipsychotic drugs market? A: The future outlook for Mellaril is bleak due to its safety concerns and the availability of newer, safer alternatives, leading to a continued decline in its market share.

Sources

  1. Research and Markets, "Global Antipsychotic Drugs Market Analysis & Trends - Industry Forecast to 2025"[1].
  2. JAMA Psychiatry, "Placebo Response in Antipsychotic Clinical Trials: A Meta-analysis"[2].
  3. Law Project for Psychiatric Rights, "DRUG TREND REPORT 2006"[3].
  4. RxList, "Mellaril (Thioridazine HCl): Side Effects, Uses, Dosage"[4].

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