Assyro AI

Orange Book product · Brand (NDA)

DUETACT

GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

Brand (NDA)NDA 021925TE ABRX TAKEDA PHARMS USA

At a glance

Jul 28, 2006

Approved

Brand (NDA)

Application

AB

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 28, 2006

    20 yr 2 mo ago

  2. Today

  3. Patent 7700128 expires

    Listed drug product patent expiration.

    Jan 30, 2027

    in 8 mo

  4. Patent 8071130 expires

    Listed drug product patent expiration.

    Jun 08, 2028

    in 2 yr

Pharmaceutical detail

Active ingredient

GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

Strength

2MG;30MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 021925

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7700128Jan 30, 2027in 8 mo
Product
8071130Jun 08, 2028in 2 yr
Product
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.