Definity microbubble approval?

See the DrugPatentWatch profile for Definity

What is Definity, and why was it approved?

Definity is an ultrasound contrast agent developed by Lantheus Holdings, a company that specializes in medical imaging and diagnostic products. It is composed of microbubbles that increase the visibility of blood and tissue when viewed under ultrasound. [1]

How does Definity work?

In 2001, the US FDA approved Definity for use in patients undergoing stress echocardiography and in patients with suboptimal echocardiograms. The microbubbles in Definity dissolve quickly, allowing for a rapid enhancement of ultrasound images, particularly in the blood and left ventricle.

However, the Definity microbubble was also used in cardiac procedures where the physician would see more of the myocardial perfusion during the ultrasound scan. However, Definity was not approved for use in these cardiac procedures until Lantheus had completed further clinical trial data.

Clinical trials and regulatory approval

Lantheus began clinical trials in 1995 for Definity in patients undergoing stress echocardiography and cardiac procedures, but was unable to achieve approval from the FDA. However Lantheus then completed more clinical trial data by 1998.

On September 25 2001 the FDA granted approval of Definity for use in adults in whom the left ventricular opacification is suboptimal or when the use of an ultrasound contrast agent is necessary to improve the diagnosis or treatment of patients.

Patent Expiration and Market Competition

The Definity patent has since expired, and the product is marketed by Lantheus as well as other companies like Sano for distribution.

According to drugpatentwatch.com, the original patent expires 2005. Since then Definity is not the only contrast agent used for ultrasound. It's a competition market in the market today for companies who would like to manufacture and sell contrast agents.

Comparison with other products

Other companies such as Sano have since released similar contrast agents. Some of these other products have different features as far as contrast agents go.

According to a 2021 study published in the Journal of Ultrasound, the main difference between Definity and other products on the market is how long they stay in the body after injection, as well as their performance in certain clinical trials.

Conclusion

To answer your question, Definity received FDA approval in 2001 for use in stress echocardiography and patients with suboptimal echocardiograms. Definity is an ultrasound contrast agent that allows for better visualization of the heart and surrounding tissue. Definity has become one of many contrast agents on the market today as the patent for Definity has expired.


Sources

[1] Lantheus.com - "What is DEFISITY".