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FDA Orange Book · active-ingredient family

Metformin hydrochloride; pioglitazone hydrochloride

Metformin hydrochloride; pioglitazone hydrochloride is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ACTOPLUS MET XR · NDA 022024

2

Brand (NDA)

6

Generics (ANDA)

4

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet, tablet, extended release

ProductApplicantApplicationTEApproved
ACTOPLUS MET XRRLD×2TAKEDA PHARMS USANDA 022024—May 12, 2009
ACTOPLUS METRLD×2TAKEDA PHARMS USANDA 021842—Aug 29, 2005

Generic (ANDA) products (6)

ProductApplicantApplicationTEApproved
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE×2MACLEODS PHARMS LTDANDA 204802ABNov 05, 2015
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE×2TEVA PHARMS USAANDA 091155ABMar 10, 2014
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE×2CHARTWELL RXANDA 091273—Apr 16, 2013
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE×2AUROBINDO PHARMA LTDANDA 200823ABFeb 13, 2013
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE×2TORRENT PHARMS LTDANDA 202001ABFeb 13, 2013
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE×2PHARMOBEDIENTANDA 090406—Feb 25, 2011

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7959946Jul 31, 2026in 1 mo
Product
7785627Jul 31, 2026in 1 mo
Product
9101660Jan 22, 2027in 7 mo
Product
9320714Feb 03, 2029in 2 yr 8 mo
Product

Metformin hydrochloride; pioglitazone hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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