Thioridazine hydrochloride - Generic Drug Details

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

Thioridazine hydrochloride is the generic ingredient in three 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 NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for thioridazine hydrochloride. Three suppliers are listed for this compound.

Summary for thioridazine hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	19
NDAs:	80
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	10
Patent Applications:	5,277
What excipients (inactive ingredients) are in thioridazine hydrochloride?	thioridazine hydrochloride excipients list
DailyMed Link:	thioridazine hydrochloride at DailyMed

Recent Clinical Trials for thioridazine hydrochloride

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

Sponsor	Phase
Rabin Medical Center	Early Phase 1
Rambam Health Care Campus	Early Phase 1
State University of New York at Buffalo	Phase 4

See all thioridazine hydrochloride clinical trials

Pharmacology for thioridazine hydrochloride

Drug Class

Phenothiazine

Anatomical Therapeutic Chemical (ATC) Classes for thioridazine hydrochloride

N05AC	Phenothiazines with piperidine structure
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for thioridazine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roxane	THIORIDAZINE HYDROCHLORIDE INTENSOL	thioridazine hydrochloride	CONCENTRATE;ORAL	088941-001	Dec 16, 1985		DISCN	No	No
West Ward	THIORIDAZINE HYDROCHLORIDE	thioridazine hydrochloride	TABLET;ORAL	088658-001	Mar 26, 1984		DISCN	No	No
Sun Pharm Industries	THIORIDAZINE HYDROCHLORIDE	thioridazine hydrochloride	TABLET;ORAL	088738-001	Oct 16, 1984		DISCN	No	No

Thioridazine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Thioridazine Hydrochloride

Introduction

Thioridazine hydrochloride, a first-generation antipsychotic drug, has a complex and evolving market dynamic due to its historical use, side effects, and regulatory changes. Here, we delve into the market dynamics and financial trajectory of this drug.

Historical Approval and Use

Thioridazine hydrochloride was first approved for use in the United States in March 1962 by Novartis Pharma AG (then known as Sandoz)[1][4].

• It was widely used for the treatment of schizophrenia and other psychiatric disorders due to its efficacy in regulating neurotransmitters such as serotonin and dopamine.

Mechanism of Action and Therapeutic Use

The drug targets the 5-HT2A receptor and D2 receptor, which are crucial for managing schizophrenia symptoms. Its mechanism involves blocking these receptors, thereby regulating neurotransmitter levels in the brain[1][5].

Market Withdrawal and Regulatory Impact

In 2005, Novartis voluntarily discontinued thioridazine worldwide due to severe cardiac arrhythmias associated with its use. However, generic forms of the drug remain available in some countries with strict regulations[3][4].

• The market withdrawal significantly impacted the drug's global availability and usage, leading to a decline in its market share.

Post-Withdrawal Market Dynamics

After the market withdrawal, the use of thioridazine diminished, but it did not completely cease. In some countries, it is still prescribed under strict conditions, typically for patients who have failed or experienced serious side effects from other antipsychotics[4].

• This limited use has maintained a niche market for the drug, albeit with stringent regulatory oversight.

Financial Trajectory

Pre-Withdrawal Financials

Before its market withdrawal, thioridazine hydrochloride generated significant revenue for Novartis due to its widespread use in treating schizophrenia and other psychiatric conditions.

• The drug's approval and acceptance globally contributed to its financial success.

Post-Withdrawal Financials

Following the withdrawal, the financial trajectory of thioridazine hydrochloride declined substantially. The reduction in sales and the need for strict regulatory compliance further diminished its revenue.

• Generic versions, while still available, contribute to a much smaller market share and revenue compared to the pre-withdrawal period.

Impact on Patients and Healthcare Systems

The withdrawal of thioridazine led to an increase in hospitalization rates for schizophrenia patients, as stable patients experienced psychotic relapses due to the lack of an effective replacement treatment[3].

• This shift has imposed additional costs on healthcare systems, as managing relapses and finding alternative treatments can be more expensive.

Alternative Treatments and Market Competition

The market for antipsychotic drugs has become increasingly competitive with the introduction of newer, safer alternatives. Studies have shown that individualized treatment rules (ITRs) using machine learning can improve treatment success rates for schizophrenia patients, potentially reducing the reliance on older drugs like thioridazine[2].

• Newer antipsychotics, such as aripiprazole and amisulpride, have become more prominent, further eroding the market share of thioridazine.

Side Effects and Safety Concerns

Thioridazine is associated with several severe side effects, including cardiac arrhythmias, extrapyramidal symptoms, and anticholinergic effects. These safety concerns have significantly impacted its market dynamics and financial trajectory[4].

• The risk of these side effects has led to strict prescribing guidelines and limited its use to only those patients who have no other treatment options.

Future Prospects

Given the current regulatory and safety landscape, the future prospects for thioridazine hydrochloride are limited. While it may still be used in certain niche cases, its overall market presence is expected to continue declining.

• Research into newer antipsychotics and personalized treatment approaches is likely to further diminish the role of thioridazine in the treatment of psychiatric disorders.

Conclusion

Thioridazine hydrochloride's market dynamics and financial trajectory have been significantly impacted by its market withdrawal, safety concerns, and the emergence of newer, safer antipsychotic drugs. While it still maintains a limited presence in the market, its future prospects are constrained by these factors.

Key Takeaways

• Thioridazine hydrochloride was widely used for schizophrenia treatment before its market withdrawal in 2005.
• The drug's use is now restricted due to severe side effects, particularly cardiac arrhythmias.
• Generic forms are still available in some countries but under strict regulations.
• The market for antipsychotic drugs has become highly competitive with newer, safer alternatives.
• The financial trajectory of thioridazine hydrochloride has declined substantially post-withdrawal.

FAQs

What was the primary reason for the market withdrawal of thioridazine hydrochloride?

The primary reason for the market withdrawal of thioridazine hydrochloride was its association with severe cardiac arrhythmias.

Which company originally manufactured thioridazine hydrochloride?

Thioridazine hydrochloride was originally manufactured by Novartis Pharma AG (then known as Sandoz).

What are the main side effects associated with thioridazine hydrochloride?

The main side effects include cardiac arrhythmias, extrapyramidal symptoms, anticholinergic effects, and other neurological and metabolic issues.

Is thioridazine hydrochloride still available in the market?

Yes, generic forms of thioridazine hydrochloride are still available in some countries, but their use is strictly regulated.

What are the alternatives to thioridazine hydrochloride for treating schizophrenia?

Alternatives include newer antipsychotics such as aripiprazole and amisulpride, which have shown better safety profiles and efficacy in treating schizophrenia.

Sources

1. Synapse by Patsnap: An In-depth Analysis of Thioridazine Hydrochloride's R&D Progress
2. JAMA Network Open: A Machine Learning Individualized Treatment Rule in First-Episode Schizophrenia
3. PubMed: Outcome of patients after market withdrawal of thioridazine
4. Wikipedia: Thioridazine
5. Tocris: Thioridazine hydrochloride