Orange Book product · Brand (NDA)

LEXISCAN

REGADENOSON

Brand (NDA)NDA 022161TE APRX ASTELLAS

Apr 10, 2008

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 10, 2008
18 yr 5 mo ago
Today
Patent 8106183 expires
Listed drug substance patent expiration.
Feb 02, 2027
in 8 mo
Patent RE47301 expires
Listed drug product patent expiration.
Feb 02, 2027
in 8 mo

Active ingredient

REGADENOSON

Strength

0.4MG/5ML (0.08MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Application

NDA 022161

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8106183	Feb 02, 2027	in 8 mo	Substance
RE47301	Feb 02, 2027	in 8 mo	Product