TRIFLUOPERAZINE HYDROCHLORIDE - Generic Drug Details

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

Trifluoperazine hydrochloride is the generic ingredient in two branded drugs marketed by Glaxosmithkline, Chartwell Rx, Wockhardt, Athem, Duramed Pharms Barr, Ivax Pharms, Mylan, Sandoz, and Watson Labs, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for trifluoperazine hydrochloride. Five suppliers are listed for this compound.

Summary for TRIFLUOPERAZINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	21
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	7
Patent Applications:	287
What excipients (inactive ingredients) are in TRIFLUOPERAZINE HYDROCHLORIDE?	TRIFLUOPERAZINE HYDROCHLORIDE excipients list
DailyMed Link:	TRIFLUOPERAZINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for TRIFLUOPERAZINE HYDROCHLORIDE

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

Sponsor	Phase
Adrianna Vlachos	Phase 1/Phase 2
Lindner Center of HOPE	Phase 2
Haining Health-Coming Biotech Co., Ltd.	Phase 2

See all TRIFLUOPERAZINE HYDROCHLORIDE clinical trials

Pharmacology for TRIFLUOPERAZINE HYDROCHLORIDE

Drug Class

Phenothiazine

Medical Subject Heading (MeSH) Categories for TRIFLUOPERAZINE HYDROCHLORIDE

Antiemetics

Antipsychotic Agents

Dopamine Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for TRIFLUOPERAZINE HYDROCHLORIDE

N05AB	Phenothiazines with piperazine structure
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

N05AB	Phenothiazines with piperazine structure
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for TRIFLUOPERAZINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Duramed Pharms Barr	TRIFLUOPERAZINE HYDROCHLORIDE	trifluoperazine hydrochloride	TABLET;ORAL	088969-001	Apr 23, 1985		DISCN	No	No
Duramed Pharms Barr	TRIFLUOPERAZINE HYDROCHLORIDE	trifluoperazine hydrochloride	TABLET;ORAL	088968-001	Apr 23, 1985		DISCN	No	No
Glaxosmithkline	STELAZINE	trifluoperazine hydrochloride	INJECTABLE;INJECTION	011552-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Mylan	TRIFLUOPERAZINE HYDROCHLORIDE	trifluoperazine hydrochloride	TABLET;ORAL	040209-001	Jul 7, 1997	AB	RX	No	No
Duramed Pharms Barr	TRIFLUOPERAZINE HYDROCHLORIDE	trifluoperazine hydrochloride	TABLET;ORAL	088967-001	Apr 23, 1985		DISCN	No	No

TRIFLUOPERAZINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Trifluoperazine Hydrochloride

Overview of Trifluoperazine Hydrochloride

Trifluoperazine hydrochloride is a phenothiazine derivative used primarily to treat schizophrenia, anxiety, and agitation. It is classified as an antipsychotic and antiemetic medication[2].

Global Import Trends

Volume and Growth

In the period from March 2023 to February 2024, the world imported 107 shipments of trifluoperazine, marking a 24% growth compared to the preceding twelve months. This growth is significant, with February 2024 alone seeing a 167% year-on-year increase and a -27% sequential decrease from January 2024[1].

Key Importers and Exporters

India leads the world in trifluoperazine imports, followed by Germany and the United States. These countries sourced their imports primarily from India, the United States, and Italy. The diverse range of importers and exporters indicates a robust global market for this medication[1].

Pricing and Cost Analysis

Shipment Values and Quantities

The prices of trifluoperazine shipments vary widely depending on the quantity and form of the medication. For example, a shipment of 25 kg of trifluoperazine HCl in April 2024 was valued at $107,675.34, while smaller quantities of trifluoperazine dihydrochloride were priced at around $131.07 per unit[1].

Dosage Strength and Pricing

The cost of trifluoperazine tablets varies by dosage strength. For instance, a 10 mg tablet can cost around $1.63, while a 5 mg tablet costs approximately $1.09. These prices indicate that the medication is relatively affordable, especially in its generic form[2].

Market Demand and Usage

Therapeutic Applications

Trifluoperazine is used to manage schizophrenia, depression, anxiety, and agitation. Its mechanism of action involves blocking postsynaptic mesolimbic dopaminergic D1 and D2 receptors, which makes it effective for treating a range of psychiatric conditions[2].

Clinical Trials and Regulatory Status

The drug has undergone various clinical trials, including Phase 1, 2, and 3 trials, and is approved for use in several countries. However, it has not been shown to be effective in managing behavioral complications in patients with mental retardation[2].

Financial Trajectory

Total Import Values

The total value of trifluoperazine imports can be substantial. For example, in a single shipment, 25 kg of trifluoperazine HCl was valued at $107,675.34. This indicates that the overall market value for trifluoperazine can be significant, especially considering the volume of imports[1].

Market Size and Growth Potential

The growth rate of 24% in imports over the past year suggests a strong demand for trifluoperazine. This growth, combined with the increasing need for psychiatric medications globally, points to a promising financial trajectory for the drug.

Challenges and Warnings

FDA Warnings

Trifluoperazine carries a black box warning from the FDA due to its increased risk of death in seniors with dementia-related psychosis. Additionally, it may cause tardive dyskinesia, a condition characterized by involuntary movements. These warnings can impact market dynamics by influencing prescribing practices and patient safety concerns[5].

Side Effects and Patient Compliance

The medication can cause a range of side effects, including dizziness, blurred vision, dry mouth, and others. These side effects can affect patient compliance and may influence the overall demand for the drug[4].

Market Opportunities

Generic Availability

Trifluoperazine is available as a generic drug, which makes it more accessible and affordable for a wider population. This generic availability can drive market growth by increasing the drug's reach and adoption[5].

Emerging Markets

The data from Volza indicates that emerging markets are becoming significant players in the trifluoperazine import market. Countries like India and Germany are among the top importers, suggesting opportunities for expansion in these and other emerging markets[1].

Key Takeaways

• Global Demand: Trifluoperazine imports have seen a significant growth rate, indicating strong global demand.
• Pricing: The medication is relatively affordable, especially in its generic form.
• Therapeutic Use: It is used to treat a range of psychiatric conditions, including schizophrenia and anxiety.
• Regulatory Considerations: The drug carries important FDA warnings, particularly regarding its use in seniors with dementia-related psychosis.
• Market Opportunities: Emerging markets and generic availability present opportunities for market expansion.

FAQs

1. What is trifluoperazine hydrochloride used for? Trifluoperazine hydrochloride is used to treat schizophrenia, anxiety, and agitation. It is classified as an antipsychotic and antiemetic medication[2].

2. Which countries are the top importers of trifluoperazine? India, Germany, and the United States are the top importers of trifluoperazine[1].

3. What are the common side effects of trifluoperazine? Common side effects include dizziness, blurred vision, dry mouth, nausea, and difficulty urinating. It can also cause more serious side effects like tardive dyskinesia[4].

4. Does trifluoperazine have any FDA warnings? Yes, trifluoperazine carries a black box warning due to its increased risk of death in seniors with dementia-related psychosis and the risk of causing tardive dyskinesia[5].

5. Is trifluoperazine available as a generic drug? Yes, trifluoperazine is available as a generic drug, making it more accessible and affordable[5].

Sources:

1. Volza.com - Trifluoperazine Imports in World
2. DrugBank - Trifluoperazine: Uses, Interactions, Mechanism of Action
3. Oregon Drug Use Review / Pharmacy & Therapeutics Committee
4. MedlinePlus - Trifluoperazine: MedlinePlus Drug Information
5. Healthline - Trifluoperazine: Side Effects, Dosage, Uses, and More