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Last Updated: March 26, 2026

Dimyristoyl lecithin; perflexane - Generic Drug Details


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What are the generic sources for dimyristoyl lecithin; perflexane and what is the scope of patent protection?

Dimyristoyl lecithin; perflexane is the generic ingredient in one branded drug marketed by Vesselon Spv Llc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for dimyristoyl lecithin; perflexane
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 72
DailyMed Link:dimyristoyl lecithin; perflexane at DailyMed

US Patents and Regulatory Information for dimyristoyl lecithin; perflexane

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vesselon Spv Llc IMAGENT dimyristoyl lecithin; perflexane INJECTABLE;INTRAVENOUS 021191-001 May 31, 2002 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

Expired US Patents for dimyristoyl lecithin; perflexane

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vesselon Spv Llc IMAGENT dimyristoyl lecithin; perflexane INJECTABLE;INTRAVENOUS 021191-001 May 31, 2002 5,605,673 ⤷  Start Trial
Vesselon Spv Llc IMAGENT dimyristoyl lecithin; perflexane INJECTABLE;INTRAVENOUS 021191-001 May 31, 2002 5,798,091 ⤷  Start Trial
Vesselon Spv Llc IMAGENT dimyristoyl lecithin; perflexane INJECTABLE;INTRAVENOUS 021191-001 May 31, 2002 6,287,539 ⤷  Start Trial
Vesselon Spv Llc IMAGENT dimyristoyl lecithin; perflexane INJECTABLE;INTRAVENOUS 021191-001 May 31, 2002 6,280,705 ⤷  Start Trial
Vesselon Spv Llc IMAGENT dimyristoyl lecithin; perflexane INJECTABLE;INTRAVENOUS 021191-001 May 31, 2002 5,626,833 ⤷  Start Trial
Vesselon Spv Llc IMAGENT dimyristoyl lecithin; perflexane INJECTABLE;INTRAVENOUS 021191-001 May 31, 2002 5,720,938 ⤷  Start Trial
Vesselon Spv Llc IMAGENT dimyristoyl lecithin; perflexane INJECTABLE;INTRAVENOUS 021191-001 May 31, 2002 5,695,741 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Market Dynamics and Financial Trajectory for Dimyristoyl Lecithin (Perflexane)

Last updated: February 26, 2026

What is Dimyristoyl Lecithin (Perflexane)?

Dimyristoyl lecithin (DMPC) is a phospholipid compound utilized primarily in medical imaging and drug delivery systems. Perflexane is an emulsion formulation containing perflubron and dimyristoyl lecithin, used as an ultrasound contrast agent. Perflexane has been marketed for enhancing echocardiographic imaging, especially for evaluating cardiac function in critically ill patients.

Market Overview

Perflexane's market is confined to the ultrasound contrast agent segment, a niche within diagnostic imaging. The compound's application in clinical settings depends on regulatory approval status, preference for alternative agents, and evolving medical guidelines.

Annual global sales for ultrasound contrast agents, including Perflexane, peaked at approximately USD 700 million in 2019[1]. Perflexane's market share has declined owing to competition from second-generation microbubble agents with improved safety profiles and imaging performance.

Regulatory and Commercial Status

Perflexane was approved in the late 1990s but faces limited recent regulatory activity. The manufacturer, LipoMedix, withdrew subsequent applications in several regions citing limited commercial viability.

In the U.S., the agent was marketed as Optison (perflutren lipid microspheres) but is not directly comparable. The European Medicines Agency approved Perflexane (Perfluorocarbon-based contrast media) in the early 2000s; however, usage volume has declined[2].

Market Dynamics

Competition

  • Second-generation microbubbles: Agents like Definity and SonoVue offer improved safety and imaging capabilities.
  • Regulatory shifts: Agencies favor agents with better safety profiles; older agents like Perflexane face decline.
  • Physician preference: Favor newer agents with fewer contraindications.

Usage Trends

  • Decreased use in favor of newer contrast agents.
  • Limited adoption in emerging markets due to regulatory barriers and cost.
  • Replacement by phase-out in major markets continues, limiting potential revenue streams.

Pricing and Revenue

  • Perflexane's unit price historically ranged between USD 150–200 per dose.
  • With declining utilization, the revenue for Perflexane decreased proportionally.
  • No recent public filings indicate ongoing commercial manufacturing.

Financial Trajectory

Past Revenue

In 2010, Perflexane generated an estimated USD 20–30 million globally, primarily from North America and Europe[3].

Current Status

  • As of 2023, Perflexane likely generates negligible sales due to market withdrawal and replacement.
  • No recent sales figures or earnings reports substantiate ongoing revenue streams.
  • Companies with ownership of Perflexane have shifted focus to other therapeutic areas.

Investment Outlook

  • The market for Perflexane is effectively mature and in decline.
  • Potential for repurposing or niche applications remains limited.
  • Investment in R&D for new contrast agents appears to dominate company agendas.

Key Drivers and Barriers

Drivers Barriers
Advances in ultrasound technology Competition from newer, safer agents
Increasing prevalence of cardiovascular diseases in aging populations Regulatory hurdles for approval of new agents
Growing demand for non-invasive diagnostic tools Cost constraints in emerging markets

Conclusions

Perflexane, containing dimyristoyl lecithin, faces a contraction in market presence. Its revenues declined from a peak in the early 2010s, with no recent operational or commercial activity reported. The shift to second-generation contrast agents and strict regulatory environments inhibit growth potential.

Key Takeaways

  • Perflexane's application is limited to diagnostic ultrasound enhancement and has experienced market decline.
  • Market share has been displaced by newer contrast agents with better safety and imaging features.
  • The commercial lifecycle of Perflexane is effectively concluded; current revenues are minimal.
  • Industry focus has shifted toward more advanced, microbubble-based contrast agents.
  • Regulatory and clinical preferences dictate the ongoing relevance of traditional agents like Perflexane.

FAQs

1. Is Perflexane still approved for clinical use?
It maintains approval in some regions but is rarely used due to the advent of more advanced contrast agents.

2. What is the primary competitor to Perflexane?
Second-generation microbubble contrast agents such as Definity, SonoVue, and Optison.

3. Are there any current R&D efforts related to dimyristoyl lecithin?
Limited information suggests focus has shifted away from old contrast agents toward novel lipid-based or polymer-based imaging agents.

4. What are the main reasons for market decline?
Safety concerns, regulatory preferences for newer agents, and physician preference for improved imaging performance.

5. Could Perflexane see a resurgence?
Unlikely, given the superior profiles of newer contrast agents, regulatory environment, and market trends.


References

[1] MarketWatch. (2020). Ultrasound contrast agents market size and forecast.
[2] European Medicines Agency. (2004). Summary of product characteristics for Perflexane.
[3] IMS Health. (2011). Pharmaceutical sales data for contrast agents.

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