Drug

Perflutren

As of the edition of 20 October 2026, Perflutren is a small molecule: marketed, first approved in 1998 (EU); US protection ends in 2035.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2001
Kind
Small molecule
Brand name
Definity
First approved
17 May 1998 (EU)
Approvals on record
4 in 2 regions
Holder of the most recent approval
Lantheus Medical Imaging; 3 holders in all
Registered trials
96, 14 stopped early
Disease areas
Cancer; Heart and blood vessels; Urinary and reproductive; Pregnancy and women's health; Skin and connective tissue; Digestive system

US protection

US protection ends in 2035.

The last listed US drug-substance patent ends in 2035. The application that gives this date is held by Lantheus Medical Imaging.

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

2 listings count towards this date. The exact date and each listing are in the product.

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Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated261554
Phase 1231084
Phase 2211235
Phase 311740
Phase 4151311
All trials96

Who has held its approvals

CompanyRoleYears
GE HealthcareApplicant1998 to now
Lantheus Medical ImagingAcquired holder and Lead sponsor of trials2004 to now
LantheusLater holder2006 to now