Orange Book product · Brand (NDA)

AMITIZA

LUBIPROSTONE

Brand (NDA)NDA 021908TE ABRX SUCAMPO PHARMA LLC

Apr 29, 2008

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 29, 2008
18 yr 5 mo ago
Today
Patent 8338639 expires
Listed drug product patent expiration.
Jan 23, 2027
in 7 mo
Patent 8779187 expires
Listed drug product patent expiration.
Jan 23, 2027
in 7 mo
Patent 8026393 expires
Listed drug product patent expiration.
Oct 25, 2027
in 1 yr 4 mo

Active ingredient

LUBIPROSTONE

Strength

8MCG

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 021908

Product number

002

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
8338639	Jan 23, 2027	in 7 mo	Product
8779187	Jan 23, 2027	in 7 mo	Product
8026393	Oct 25, 2027	in 1 yr 4 mo	Product