Orange Book product · Brand (NDA)

ENTEREG

ALVIMOPAN

Brand (NDA)NDA 021775DISCN CUBIST PHARMS

May 20, 2008

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 20, 2008
18 yr 4 mo ago
Today
Patent 8946262 expires
Listed method-of-use patent (U-1655) expiration.
Feb 12, 2030
in 3 yr 8 mo

Active ingredient

ALVIMOPAN

Strength

12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 021775

Product number

001

Marketing status

DISCN

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
8946262	Feb 12, 2030	in 3 yr 8 mo	U-1655