FDA Orange Book · active-ingredient family
Glimepiride; pioglitazone hydrochloride
Glimepiride; pioglitazone hydrochloride is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DUETACT · NDA 021925
1
Brand (NDA)
1
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DUETACTRLD×2 | TAKEDA PHARMS USA | NDA 021925 | AB | Jul 28, 2006 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE×2 | CHARTWELL RX | ANDA 201049 | AB | Jan 04, 2013 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7700128 | Jan 30, 2027 | in 8 mo | Product |
| 8071130 | Jun 08, 2028 | in 2 yr | Product |
Glimepiride; pioglitazone hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
