Drug facts

Molecule

Regadenoson (Lexiscan)

Generics already compete: 11 makers on the market. 11 A-rated products from 11 makers substitute at the counter.

Lexiscan was first approved by the FDA on 04/10/2008 under NDA 022161; the application holder is Astellas Pharma US Inc.

The most recent FDA recall on record is a Class II recall dated 10/30/2024.

Holder Astellas Pharma US IncApplication NDA 022161Approved 04/10/2008

01Patents and exclusivity

When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.

94days until the latest patent expires

ExclusivityPatent onlyOpen to generics
Today
Approved04/10/2008
Last patent02/02/2027
2009201220152018202120242027
Latest patent
02/02/2027Lexiscan
Orange Book

02Competition

Generics
11 generic makers
Orange Book
First generic approved
04/11/2022
Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Regadenoson profile.See what is included

03Supply and price

FDA drug shortage
ClearNot on the current shortage list
FDA shortages
Latest recall
10/30/2024Class II, Regadenoson, Baxter Healthcare Corporation
FDA enforcement

04Product

Application holder
Astellas Pharma US Inc
Orange Book
Application
NDA 022161
Orange Book
First approved
04/10/2008
Orange Book
Dosage forms
solution
Routes
intravenous

Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.