FDA Orange Book · active-ingredient family
Pioglitazone hydrochloride
Pioglitazone hydrochloride is approved as 1 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ACTOS · NDA 021073
1
Brand (NDA)
15
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACTOSRLD×3 | TAKEDA PHARMS USA | NDA 021073 | AB | Jul 15, 1999 |
Generic (ANDA) products (15)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PIOGLITAZONE HYDROCHLORIDE×3 | COREPHARMA | ANDA 210165 | AB | Jan 22, 2021 | |
| PIOGLITAZONE HYDROCHLORIDE×3 | PRINSTON INC | ANDA 207806 | AB | Apr 17, 2018 | |
| PIOGLITAZONE HYDROCHLORIDE×3 | PURACAP PHARM LLC | ANDA 206738 | AB | Oct 06, 2017 | |
| PIOGLITAZONE HYDROCHLORIDE×3 | ANNORA PHARMA | ANDA 204133 | AB | Apr 07, 2014 | |
| PIOGLITAZONE HYDROCHLORIDE×3 | TEVA PHARMS USA | ANDA 077210 | AB | Jan 10, 2014 | |
| PIOGLITAZONE HYDROCHLORIDE×3 | CHARTWELL RX | ANDA 078383 | — | Mar 12, 2013 | |
| PIOGLITAZONE HYDROCHLORIDE×3 | ACCORD HLTHCARE | ANDA 200044 | AB | Feb 13, 2013 | |
| PIOGLITAZONE HYDROCHLORIDE×3 | AIPING PHARM INC | ANDA 078670 | AB | Feb 13, 2013 | |
| PIOGLITAZONE HYDROCHLORIDE×3 | AUROBINDO PHARMA LTD | ANDA 200268 | AB | Feb 13, 2013 | |
| PIOGLITAZONE HYDROCHLORIDE×3 | PHARMOBEDIENT | ANDA 078472 | — | Feb 13, 2013 | |
| PIOGLITAZONE HYDROCHLORIDE×3 | TORRENT PHARMS LTD | ANDA 091298 | — | Feb 13, 2013 | |
| PIOGLITAZONE HYDROCHLORIDE×3 | ZYDUS PHARMS USA INC | ANDA 202456 | AB | Feb 13, 2013 | |
| PIOGLITAZONE HYDROCHLORIDE×3 | MACLEODS PHARMS LTD | ANDA 202467 | AB | Feb 06, 2013 | |
| PIOGLITAZONE HYDROCHLORIDE×3 | CHARTWELL RX | ANDA 076798 | AB | Oct 26, 2012 | |
| PIOGLITAZONE HYDROCHLORIDE×3 | PHARMOBEDIENT | ANDA 076801 | — | Aug 17, 2012 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Pioglitazone hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
