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Last Updated: December 22, 2024

MELLARIL-S Drug Patent Profile


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When do Mellaril-s patents expire, and what generic alternatives are available?

Mellaril-s is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in MELLARIL-S 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-S
Drug patent expirations by year for MELLARIL-S
Recent Clinical Trials for MELLARIL-S

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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-S

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis MELLARIL-S thioridazine SUSPENSION;ORAL 017923-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis MELLARIL-S thioridazine SUSPENSION;ORAL 017923-002 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-S Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Mellaril (Thioridazine HCl)

Introduction to Mellaril

Mellaril, also known as thioridazine HCl, is a first-generation antipsychotic medication belonging to the phenothiazine class. It is primarily used to manage psychotic disorders, particularly schizophrenia, in patients who have not responded adequately to other antipsychotic treatments[1][2][5].

Historical Context and Market Presence

Mellaril was first introduced in the late 1950s and was widely used for several decades. However, due to its significant side effects and potential for life-threatening cardiac arrhythmias, its use has been severely restricted. The drug was officially withdrawn from the market in 2005 due to these safety concerns[4].

Safety Concerns and Regulatory Actions

One of the most critical factors affecting the market dynamics of Mellaril is its association with serious cardiac side effects. The drug prolongs the QTc interval, which can lead to torsade de pointes-type arrhythmias and sudden death. These risks have led to strict warnings and contraindications, limiting its use to only those patients who have failed other antipsychotic treatments[1][5].

Impact of Market Withdrawal

The withdrawal of Mellaril from the market had significant implications for patients who were stable on the medication. A study in Finland found that the market withdrawal led to an increase in hospitalization rates for schizophrenia, as many patients experienced psychotic relapses. This highlights the need for a thorough risk-benefit assessment and a clear plan for replacing antipsychotic medications before market withdrawal[4].

Financial Trajectory

Given the drug's withdrawal from the market, the financial trajectory of Mellaril has been significantly impacted. Prior to its withdrawal, Mellaril was marketed by several pharmaceutical companies, including Novartis and Sandoz. However, since 2005, there has been no new revenue generated from the sale of this drug.

Pre-Withdrawal Financials

Before its market withdrawal, Mellaril generated revenue through its various formulations, including tablets and liquid suspensions. The drug was prescribed for a specific patient population, albeit with strict guidelines due to its side effects.

Post-Withdrawal Financials

Following the market withdrawal, the financial performance of Mellaril has been non-existent. Pharmaceutical companies have shifted focus to other antipsychotic medications with better safety profiles and more favorable market dynamics.

Market Replacement and Alternatives

The withdrawal of Mellaril has led to an increased reliance on other antipsychotic medications. Modern antipsychotics, both first-generation and second-generation, have become the preferred treatments due to their improved safety profiles and efficacy.

Second-Generation Antipsychotics

Second-generation antipsychotics, such as olanzapine and risperidone, have become more prevalent due to their lower risk of extrapyramidal side effects and other adverse reactions compared to first-generation antipsychotics like Mellaril.

Market Trends in Antipsychotic Medications

The market for antipsychotic medications continues to evolve, driven by advancements in pharmacology and changing patient needs. There is a growing preference for medications with minimal side effects and those that improve the quality of life for patients. This trend is reflected in the broader pharmaceutical market, where patient-centric approaches and safety profiles are key drivers of market dynamics[3].

Conclusion

The market dynamics and financial trajectory of Mellaril (thioridazine HCl) have been significantly impacted by its safety concerns and subsequent market withdrawal. While it was once a treatment option for schizophrenia, its use is now highly restricted and largely obsolete. The pharmaceutical industry has moved towards safer and more effective antipsychotic medications, reflecting broader trends in patient care and safety.

Key Takeaways

  • Safety Concerns: Mellaril is associated with serious cardiac side effects, including QTc interval prolongation and torsade de pointes-type arrhythmias.
  • Market Withdrawal: The drug was withdrawn from the market in 2005 due to these safety concerns.
  • Impact on Patients: The withdrawal led to increased hospitalization rates for schizophrenia as patients experienced psychotic relapses.
  • Financial Impact: The financial trajectory of Mellaril has been severely impacted, with no new revenue generated since its market withdrawal.
  • Market Alternatives: Second-generation antipsychotics have become the preferred treatments due to their improved safety profiles.

FAQs

What is Mellaril used for?

Mellaril (thioridazine HCl) is used to treat schizophrenia in patients who have not responded adequately to other antipsychotic medications.

Why was Mellaril withdrawn from the market?

Mellaril was withdrawn from the market in 2005 due to its association with serious cardiac side effects, including QTc interval prolongation and torsade de pointes-type arrhythmias.

What are the side effects of Mellaril?

Mellaril can cause a range of side effects, including cardiac arrhythmias, sedation, dry mouth, constipation, and blurred vision. It also has rare but serious side effects such as torsade de pointes-type arrhythmias and sudden death.

What alternatives are available for treating schizophrenia?

Alternatives to Mellaril include second-generation antipsychotics like olanzapine and risperidone, which have better safety profiles and are more commonly prescribed.

How did the market withdrawal of Mellaril affect patients?

The market withdrawal of Mellaril led to an increase in hospitalization rates for schizophrenia as many patients who were stable on the medication experienced psychotic relapses.

Sources

  1. RxList: Mellaril (Thioridazine HCl): Side Effects, Uses, Dosage.
  2. DrugBank: Thioridazine: Uses, Interactions, Mechanism of Action.
  3. Statista: Multiple Sclerosis Drugs - Global | Market Forecast.
  4. PubMed: Outcome of patients after market withdrawal of thioridazine.
  5. WebMD: Thioridazine: Uses, Side Effects, Interactions, Pictures.

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