Orange Book product · Brand (NDA)

ORFADIN

NITISINONE

Brand (NDA)NDA 206356RX SWEDISH ORPHAN

Apr 22, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 22, 2016
10 yr 4 mo ago
Today
Patent 9301932 expires
Listed drug product patent expiration.
Feb 28, 2033
in 6 yr 10 mo

Active ingredient

NITISINONE

Strength

4MG/ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 206356

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
9301932	Feb 28, 2033	in 6 yr 10 mo	ProductU-1836