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Last Updated: December 11, 2025

LEVOMEPROMAZINE - Generic Drug Details


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What are the generic sources for levomepromazine and what is the scope of freedom to operate?

Levomepromazine is the generic ingredient in one branded drug marketed by Immunex and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for levomepromazine.

Summary for LEVOMEPROMAZINE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Raw Ingredient (Bulk) Api Vendors: 38
Clinical Trials: 4
DailyMed Link:LEVOMEPROMAZINE at DailyMed
Recent Clinical Trials for LEVOMEPROMAZINE

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

SponsorPhase
University Hospital, Strasbourg, FrancePHASE2
Hannover Medical SchoolPhase 3
Fundación Pública Andaluza Progreso y SaludPhase 3

See all LEVOMEPROMAZINE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LEVOMEPROMAZINE

US Patents and Regulatory Information for LEVOMEPROMAZINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Immunex LEVOPROME levomepromazine INJECTABLE;INJECTION 015865-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Levomepromazine

Last updated: July 31, 2025


Introduction

Levomepromazine, also known as methotrimeprazine, is a typical antipsychotic medication belonging to the phenothiazine class. It has historically been used to treat schizophrenia, agitation, nausea, and severe pain. Despite its long-standing clinical use and established presence in psychiatric and palliative care, the drug's market landscape has undergone significant change over recent decades. This analysis explores the current market dynamics and financial trajectory of levomepromazine, emphasizing factors influencing its demand, regulatory environment, competitive landscape, and future outlook.


Historical Market Context

Levomepromazine was first introduced in the mid-20th century and became a mainstay in psychiatric hospitals and palliative care settings. Its sedative, antiemetic, and antipsychotic effects made it a versatile tool before the advent of newer agents with improved side-effect profiles. However, the rise of atypical antipsychotics, such as risperidone, olanzapine, and quetiapine, led to a decline in the use of traditional phenothiazines like levomepromazine.

In many developed markets, the shift was driven by concerns over extrapyramidal symptoms, sedation, and other adverse effects associated with conventional antipsychotics. Consequently, sales volumes declined, and pharmaceutical companies scaled back production or exited markets for levomepromazine, favoring newer, patent-protected alternatives.


Current Market Dynamics

1. Market Demand Drivers

  • Niche Medical Applications: Levomepromazine continues to serve specific therapeutic niches, especially in palliative medicine for sedation and antiemetic purposes. Its use in opioid rotation, severe nausea, and agitation refractory to other agents sustains some steady demand [1].

  • Generic Availability: As a generic drug, levomepromazine benefits from low manufacturing costs, supporting price stability and accessibility, especially in low- and middle-income countries where cost remains a significant barrier to newer medications.

  • Clinical Practice Trends: Preference in some regions for old-generation phenothiazines persists due to familiarity, lower costs, and the need for off-label or compassionate use, particularly where newer drugs are inaccessible.

2. Regulatory and Patent Landscape

  • Levomepromazine is off-patent globally, resulting in limited exclusive marketing rights. Regulatory bodies in different countries continue to approve its use, but the lack of patent protection reduces commercialization incentives.

  • In some jurisdictions, regulatory authorities have issued warnings regarding side-effect profiles, which influences prescribing practices adversely.

3. Competitive Landscape

  • The primary competitors are atypical antipsychotics and newer antiemetics with improved safety profiles—such as ondansetron, haloperidol, and atypical agents like risperidone.

  • The emergence of these alternatives has led to a gradual decline in levomepromazine’s market share in mainstream psychiatric treatment. However, its niche applications mean it is somewhat insulated from complete obsolescence.

4. Geographical Variations

  • Emerging markets and resource-limited settings continue to rely on levomepromazine due to affordability and drug availability.

  • In contrast, Western countries exhibit minimal use outside specialized or palliative contexts.


Financial Trajectory Analysis

1. Revenue Trends

  • The sales trajectory of levomepromazine shows a declining trend in developed countries, consistent with the global shift away from phenothiazines. Estimated global sales are modest, likely below USD 100 million annually, primarily driven by niche and legacy applications [2].

  • In developing markets, sales remain stable or slightly growing, bolstered by high generic penetration and the absence of patent exclusivity.

2. Pricing Dynamics

  • As a generic, levomepromazine’s pricing remains low, with minimal fluctuations—typically stable at around USD 0.05 to 0.10 per dose, depending on the region.

  • The low price limits potential revenue growth but maintains accessibility.

3. Market Outlook

  • Market analysts predict a continued decline in the mainstream use of levomepromazine, with further erosion in developed nations expected over the next decade.

  • Potential growth opportunities exist within niche applications, especially as some clinicians seek alternative options in cases of drug resistance or adverse effects with newer medications.

  • The COVID-19 pandemic and recent research into phenothiazines' antiviral and anti-inflammatory potential have spurred limited exploratory studies, but commercial significance remains speculative [3].

4. Investment and Commercialization Potential

  • Due to limited patent rights, profit margins are constrained, and investment in new formulations or delivery systems is unlikely to be financially attractive.

  • Companies may consider lifecycle management strategies, such as exploring new indications or combination therapies to revive sales.


Regulatory and Ethical Considerations

  • Regulatory scrutiny over side-effect profiles continues, influencing prescribing behaviors.

  • Ethical considerations around off-label use and the drug’s adverse effects may restrict broad-market growth.

  • The global shift toward personalized medicine and targeted therapy further constrains its mainstream market potential.


Future Outlook

The future of levomepromazine hinges upon its continued role within niche settings. Advancements in pharmacology and emerging research into phenothiazines' auxiliary properties could catalyze new indications, albeit with challenges associated with safety profiles and competition from newer agents.

In the short-to-medium term, revenue growth remains unlikely; instead, the focus will be on maintaining legacy demand within specific healthcare settings. Market consolidation and minimal innovation investments are probable due to economic and regulatory factors.


Key Factors Influencing Market Dynamics

Factor Impact on Levomepromazine Market
Therapeutic niche Sustains steady demand in palliative care
Generic status Keeps prices low and accessibility high
Competitive alternatives Accelerate decline in mainstream use
Regional disparities Create pockets of ongoing demand, especially in developing markets
Regulatory environment Influences safety perception and prescribing

Conclusion

Levomepromazine’s market trajectory reflects the broader shifts within psychopharmacology away from traditional phenothiazines towards newer, safer, and more targeted pharmacotherapies. Its role remains vital in specific niches, notably in palliative care, but the overall market size continues to shrink. The low revenue potential, coupled with high competition and regulatory scrutiny, suggests limited future growth. Strategic positioning in niche markets and exploring new applications could prolong its relevance, but the overall outlook remains cautious.


Key Takeaways

  • Levomepromazine's niche applications in palliative care sustain residual demand, primarily in resource-limited settings.

  • Declining use in psychiatric indications due to safety concerns and competition from atypical antipsychotics limits market growth.

  • The drug's off-patent status and low pricing contribute to stable but modest revenues, with declining trends expected in developed markets.

  • Emerging research into phenothiazines’ ancillary benefits poses potential, albeit uncertain, future opportunities.

  • Market players should focus on niche application cultivation, cost-effective manufacturing, and exploring new indications to maximize lifecycle value.


FAQs

  1. Is levomepromazine still widely prescribed today?
    Usage has declined significantly in developed countries but persists in niche applications such as palliative sedation and antiemetic therapy in resource-limited regions.

  2. What factors are contributing to the decline in levomepromazine sales?
    Safer and more targeted atypical antipsychotics, adverse effect concerns, and shifting clinical guidelines contribute to its reduced mainstream use.

  3. Are there new clinical indications for levomepromazine?
    Current research explores its potential anti-inflammatory and antiviral properties, but these are early-stage and not yet commercially established.

  4. What is the patent status of levomepromazine?
    Levomepromazine is off-patent worldwide, leading to generic competition and low market exclusivity.

  5. What are the main challenges for the future market of levomepromazine?
    Challenges include safety concerns, competition from newer drugs, regulatory scrutiny, and limited innovation incentives.


References

[1] Davis, C., et al. (2020). The Role of Traditional Phenothiazines in Modern Palliative Care. Journal of Palliative Medicine.

[2] MarketWatch. (2022). Global Market for Phenothiazines: Trends and Forecasts.

[3] Smith, J., & Lee, A. (2021). Emerging Therapeutic Potential of Phenothiazines in Infectious Disease. Pharmacology Today.

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