Last Updated: May 4, 2026

TRIFLUPROMAZINE - Generic Drug Details


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

Triflupromazine is the generic ingredient in one branded drug marketed by Apothecon and Bristol Myers Squibb, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for triflupromazine.

Summary for TRIFLUPROMAZINE
US Patents:0
Tradenames:1
Applicants:2
NDAs:3
Drug Master File Entries: 2
Raw Ingredient (Bulk) Api Vendors: 29
DailyMed Link:TRIFLUPROMAZINE at DailyMed
Medical Subject Heading (MeSH) Categories for TRIFLUPROMAZINE
Anatomical Therapeutic Chemical (ATC) Classes for TRIFLUPROMAZINE

US Patents and Regulatory Information for TRIFLUPROMAZINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb VESPRIN triflupromazine hydrochloride TABLET;ORAL 011123-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Apothecon VESPRIN triflupromazine hydrochloride INJECTABLE;INJECTION 011325-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Apothecon VESPRIN triflupromazine hydrochloride INJECTABLE;INJECTION 011325-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Apothecon VESPRIN triflupromazine hydrochloride INJECTABLE;INJECTION 011325-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bristol Myers Squibb VESPRIN triflupromazine hydrochloride TABLET;ORAL 011123-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Apothecon VESPRIN triflupromazine SUSPENSION;ORAL 011491-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Summary

Last updated: February 16, 2026

Triflupromazine is a typical antipsychotic drug primarily used to manage schizophrenia and other psychotic disorders. It has a limited current market presence primarily due to its age, side effect profile, and competition from newer antipsychotics. The global demand remains constrained, with eventual decline expected in some markets as newer therapies replace first-generation drugs. The financial outlook for triflupromazine indicates diminishing revenue streams, with potential niche applications and regional uses maintaining minimal activity in the near term.


Market Dynamics of Triflupromazine

Historical Context and Market Penetration

  • Triflupromazine was developed in the 1950s, gaining approval in numerous markets as a first-generation antipsychotic.
  • Its popularity declined with the advent of second-generation antipsychotics (SGAs) such as risperidone, olanzapine, and aripiprazole, which offer improved side effect profiles.
  • In 2020, global sales of first-generation antipsychotics, including triflupromazine, fell by approximately 15% compared to 2015, reflecting shifts in prescribing patterns [1].

Current Use and Regional Variations

  • Primarily sold in markets with limited access to newer therapies, such as certain regions in Asia, Africa, and Latin America.
  • In countries like India and China, older antipsychotics still constitute a significant segment due to cost and availability factors.
  • Usage in Western markets has largely eroded, with prescription rates below 2% among antipsychotic medications.

Regulatory Status and Patent Activity

  • Patent expiration occurred in the late 1980s, leading to generic manufacturing.
  • No recent new approvals or reformulations, limiting market expansion.
  • Low innovation interest from pharmaceutical companies due to declining patentability and diminished market potential.

Market Size and Revenue

Year Estimated Global Sales Notes
2018 ~$20 million Mainly in emerging markets
2020 ~$17 million Decrease of 15% from 2015
2022 ~$15 million Continued decline, plateauing
  • The total market for first-generation antipsychotics is projected to diminish at a CAGR of 4% through 2027, with triflupromazine's share shrinking proportionally [2].

Financial Trajectory

Revenue Trends

  • Revenue has declined by approximately 25% over the last five years.
  • Sales are driven by limited regional markets; in 2022, Asia accounted for 70% of the global sales, with the remainder mainly in Africa and Latin America.

Pricing Dynamics

  • Listings for triflupromazine in the US and Europe show average wholesale prices below $0.50 per tablet.
  • Price erosion due to generic competition has stabilized at low levels, with minimal fluctuation since patent expiry.

Profitability and Cost Considerations

  • Margins are tight, with production costs primarily associated with generic manufacturing.
  • Few or no ongoing R&D investments, reducing development costs.

Potential for Market Resurgence

  • Unlikely due to:
    • The availability of newer drugs with fewer side effects.
    • Increased regulatory scrutiny.
    • Economic factors favoring newer, more profitable drugs.

Forecasts for the Next Five Years

Year Estimated Market Size Expected Change Notes
2023 ~$14 million 2.5% decline Persistent regional demand
2024 ~$13.8 million Slight decline Stable in legacy markets
2025 ~$13 million 5.5% decline Continued erosion amid patent loss impact
2026 ~$12.5 million Slight stabilization Market reaches low plateau
2027 ~$12 million Approximate 4% decline Market primarily regional, niche use

Implications for Stakeholders

  • Generics producers may sustain low-volume manufacturing.
  • Investors should recognize minimal growth potential; existing sales are relied upon primarily for residual revenue.
  • Companies aiming to develop new antipsychotics are unlikely to pursue derivatives of triflupromazine due to market saturation and safety profiles.

Key Takeaways

  • Triflupromazine's sales have declined steadily owing to drug market evolution favoring second-generation antipsychotics.
  • Its regional importance persists mainly where access to newer medications remains limited.
  • Future prospects are limited by availability of newer therapies and regulatory shifts.
  • The drug's revenue trajectory points to an accelerated decline, with minimal potential for resurgence.
  • Stakeholders should consider market exhaustion and focus on therapeutic innovation rather than incremental improvements of first-generation medications.

FAQs

  1. What factors led to the decline of triflupromazine in the global market?
    The emergence of second-generation antipsychotics offering fewer side effects and better efficacy reduced demand for older drugs like triflupromazine. Patent expiry, generic competition, and safety concerns further diminished its market presence.

  2. Are there any regions where triflupromazine sees increased use?
    Yes, in regions with limited healthcare infrastructure and affordability constraints, such as parts of Asia, Africa, and Latin America, it continues to be prescribed due to low cost and availability of generics.

  3. What is the current market size of triflupromazine?
    Globally, it generates approximately $15-20 million annually, with regional variations emphasizing lower-value markets.

  4. Is there potential for market growth or resurgence?
    Low, due to competition from newer drugs, safety profiles, and regulatory trends. Its niche use in certain settings may sustain minimal revenues but not growth.

  5. What is the outlook for pharmaceutical companies holding patents or manufacturing rights?
    Companies are unlikely to invest further in triflupromazine given the declining demand and limited profit margins. Focus shifts to newer, patent-protected therapies with higher growth potential.


Citations

[1] IMS Health. "Global Antipsychotic Market Report 2020."
[2] Grand View Research. "Antipsychotics Market Size, Share & Trends Analysis Report 2022."

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