Orange Book product · Brand (NDA)

FULVESTRANT

Brand (NDA)NDA 210326TE AORX FRESENIUS KABI USA

May 20, 2019

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 20, 2019
7 yr 2 mo ago
Today
Patent 10188663 expires
Listed drug product patent expiration.
Feb 14, 2034
in 7 yr 9 mo
Patent 9833459 expires
Listed drug product patent expiration.
Feb 14, 2034
in 7 yr 9 mo
Patent 9271990 expires
Listed drug product patent expiration.
May 17, 2034
in 8 yr

Active ingredient

FULVESTRANT

Strength

250MG/5ML (50MG/ML)

Dosage form

SOLUTION

Route

INTRAMUSCULAR

TE code

Application

NDA 210326

Product number

001

Marketing status

Reference listed drug (RLD)

Reference standard (RS)

Active-ingredient family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10188663	Feb 14, 2034	in 7 yr 9 mo	ProductU-2540
9833459	Feb 14, 2034	in 7 yr 9 mo	ProductU-2540
9271990	May 17, 2034	in 8 yr	ProductU-2540