Orange Book product · Brand (NDA)

OSENI

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE

Brand (NDA)NDA 022426DISCN TAKEDA PHARMS USA

Jan 25, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 25, 2013
13 yr 7 mo ago
Today
Patent 7807689 expires
Listed drug substance patent expiration.
Jun 27, 2028
in 2 yr 1 mo
Patent 8637079 expires
Listed drug product patent expiration.
Jun 04, 2029
in 3 yr

Active ingredient

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE

Strength

EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 022426

Product number

004

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
7807689	Jun 27, 2028	in 2 yr 1 mo	SubstanceProductU-1337
8637079	Jun 04, 2029	in 3 yr	Product