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Last Updated: March 19, 2026

LEVOPROME Drug Patent Profile


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Which patents cover Levoprome, and what generic alternatives are available?

Levoprome is a drug marketed by Immunex and is included in one NDA.

The generic ingredient in LEVOPROME is levomepromazine. There are two drug master file entries for this compound. Additional details are available on the levomepromazine profile page.

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Summary for LEVOPROME
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for LEVOPROME

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

Investment Scenario and Fundamentals Analysis for Levoprome

Last updated: February 3, 2026

What Is Levoprome?

Levoprome is a pharmaceutical compound containing levopropropazine, classified as an antipsychotic and antiemetic. It is chemically related to phenothiazines, offering dopamine receptor antagonism. The drug’s clinical use has historically focused on anxiety, nausea, and psychiatric disorders, but its market presence has declined due to safety concerns and competition from newer agents.

Market Overview and Demand Drivers

Current Market Status

Levoprome’s availability is limited primarily to generic drug markets in select regions, such as Eastern Europe and parts of Asia. No significant branded formulations are in U.S. or European markets.

Demand Drivers

  • Niche Uses: Used in specific psychiatric indications and nausea management in cases resistant to other treatments.
  • Unmet Needs: Potential in specialized patient populations, including those with contraindications to newer drugs.

Market Size

The global antiemetic market was valued at approximately USD 2.5 billion in 2021 (Grand View Research). Drugs like promethazine and chlorpromazine dominate, with off-label use for nausea and psychiatric conditions. Levoprome’s share remains negligible, estimated under USD 10 million globally.

Patent and Regulatory Landscape

Patent Status

Levoprome is off-patent globally, with no recent patents securing exclusivity for its formulations. This leads to high generic competition and price erosion.

Regulatory Environment

  • Approved in some markets under generic status.
  • Regulatory hurdles are minimal in regions where it has existing approval but significant in markets requiring new drug application (NDA) processes.

Competitive Position

Key Competitors

  • Promethazine
  • Chlorpromazine
  • Haloperidol

Differentiators

Levoprome’s differentiation from competitors hinges on its receptor profile, side-effect profile, and potential off-label benefits. However, safety concerns, particularly extrapyramidal symptoms, limit its adoption.

R&D and Commercialization Challenges

  • Limited R&D activity due to its age and patent expiry.
  • No significant pipeline or reformulation projects announced.
  • Commercialization opportunities are confined to niche segments or markets with less competition.

Financial Outlook

Investment Risks

  • Market decline due to safety issues and newer drugs.
  • Entry barriers are low for generics, pushing prices downward.
  • Lack of patent protection reduces pricing power and profitability.

Potential Upside

  • Regulatory approval in unexploited markets
  • Development of new formulations or combination therapies
  • Expansion into niche psychiatric or antiemetic markets

Valuation

Given the minimal current market penetration and high competition, Levoprome is unlikely to generate significant revenue without strategic repositioning or new indications.

Policy and Industry Trends

  • Shift towards drugs with better safety profiles.
  • Increasing regulatory scrutiny on older antipsychotics.
  • Growing preference for targeted therapies with fewer side effects.

Key Considerations for Investors

  • The drug’s off-patent status and generic competition limit potential profits.
  • Niche demand exists but is insufficient for robust growth.
  • Future prospects depend on reformulation, new indications, or market expansion strategies.

Key Takeaways

Levoprome’s investment potential is limited by its aging status, lack of patent protection, and high competition from established drugs. The drug remains relevant in niche markets, but major growth is unlikely unless targeted reforms or indications are developed. Market dynamics favor drugs with better safety profiles and patent protection, reducing Levoprome’s attractiveness for broad-based investment.

Frequently Asked Questions

1. Is Levoprome suitable for development into new formulations?
Potentially, if safety profiles are improved or if it can be combined with other agents to reduce side effects.

2. Can further patent protection be secured?
No, as the active ingredient is off-patent; only formulations or delivery methods could be patentable.

3. What are the primary safety concerns?
Extrapyramidal symptoms, sedation, and potential cardiovascular effects limit its use.

4. Is there geographic potential for growth?
Limited, primarily in countries with less stringent regulatory environments and existing generic markets.

5. How does Levoprome compare with similar drugs?
It is less favored than newer agents like ondansetron or quetiapine, due to safety profile and market acceptance.


Citations

[1] Grand View Research, "AntiEmetics Market Size, Share & Trends Analysis," 2021.

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