Orange Book product · Brand (NDA)

MYHIBBIN

MYCOPHENOLATE MOFETIL

Brand (NDA)NDA 216482RX AZURITY

May 01, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 01, 2024
2 yr 2 mo ago
Today
Patent 11931455 expires
Listed drug product patent expiration.
Aug 16, 2039
in 13 yr 4 mo
Patent 12097284 expires
Listed drug product patent expiration.
Aug 16, 2039
in 13 yr 4 mo
Patent 12097285 expires
Listed drug product patent expiration.
Aug 16, 2039
in 13 yr 4 mo
Patent 12194143 expires
Listed drug product patent expiration.
Aug 16, 2039
in 13 yr 4 mo
Patent 12226526 expires
Listed drug product patent expiration.
Aug 16, 2039
in 13 yr 4 mo

Active ingredient

MYCOPHENOLATE MOFETIL

Strength

200MG/ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 216482

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
11931455	Aug 16, 2039	in 13 yr 4 mo	ProductU-1752
12097284	Aug 16, 2039	in 13 yr 4 mo	Product
12097285	Aug 16, 2039	in 13 yr 4 mo	ProductU-1752
12194143	Aug 16, 2039	in 13 yr 4 mo	ProductU-1752
12226526	Aug 16, 2039	in 13 yr 4 mo	ProductU-1752