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Last Updated: December 22, 2024

TRIFLUOPERAZINE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Trifluoperazine Hydrochloride, and what generic alternatives are available?

Trifluoperazine Hydrochloride is a drug marketed by Chartwell Rx, Wockhardt, Athem, Duramed Pharms Barr, Ivax Pharms, Mylan, Sandoz, and Watson Labs. and is included in twenty NDAs.

The generic ingredient in TRIFLUOPERAZINE HYDROCHLORIDE is trifluoperazine hydrochloride. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the trifluoperazine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Trifluoperazine Hydrochloride

A generic version of TRIFLUOPERAZINE HYDROCHLORIDE was approved as trifluoperazine hydrochloride by SANDOZ on December 31st, 1969.

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Summary for TRIFLUOPERAZINE HYDROCHLORIDE
Drug patent expirations by year for TRIFLUOPERAZINE HYDROCHLORIDE
Recent Clinical Trials for TRIFLUOPERAZINE HYDROCHLORIDE

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

SponsorPhase
Adrianna VlachosPhase 1/Phase 2
Lindner Center of HOPEPhase 2
Alphacait, LLCPhase 2

See all TRIFLUOPERAZINE HYDROCHLORIDE clinical trials

Pharmacology for TRIFLUOPERAZINE HYDROCHLORIDE
Drug ClassPhenothiazine
Medical Subject Heading (MeSH) Categories for TRIFLUOPERAZINE HYDROCHLORIDE

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
Chartwell Rx TRIFLUOPERAZINE HYDROCHLORIDE trifluoperazine hydrochloride CONCENTRATE;ORAL 085787-001 Apr 15, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan TRIFLUOPERAZINE HYDROCHLORIDE trifluoperazine hydrochloride TABLET;ORAL 040209-004 Jul 7, 1997 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs TRIFLUOPERAZINE HYDROCHLORIDE trifluoperazine hydrochloride TABLET;ORAL 085976-001 Jun 23, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Duramed Pharms Barr TRIFLUOPERAZINE HYDROCHLORIDE trifluoperazine hydrochloride TABLET;ORAL 088967-001 Apr 23, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Athem TRIFLUOPERAZINE HYDROCHLORIDE trifluoperazine hydrochloride TABLET;ORAL 040153-002 Oct 25, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ivax Pharms TRIFLUOPERAZINE HYDROCHLORIDE trifluoperazine hydrochloride TABLET;ORAL 087613-001 Nov 19, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz TRIFLUOPERAZINE HYDROCHLORIDE trifluoperazine hydrochloride TABLET;ORAL 085786-001 Approved Prior to Jan 1, 1982 AB RX 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

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

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