FDA Orange Book
Generic for Duetact
Duetact contains pioglitazone and glimepiride. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Duetact is pioglitazone and glimepiride. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Duetact and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Duetact products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 2MG;30MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 4MG;30MG | Marketed (Rx) | AB | 1 | AB |
NDA 021925, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pioglitazone and glimepiride
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 201049 | AB (A-rated, therapeutically equivalent) | January 4, 2013 | 2MG;30MG, 4MG;30MG |
Duetact patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7700128 | January 30, 2027 | Drug product | None | 021925 |
| 8071130 | June 8, 2028 | Drug product | None | 021925 |
Duetact NDC codes
Questions
Is there a generic for Duetact?
Yes. The generic name for Duetact is pioglitazone and glimepiride. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Duetact?
The active ingredient in Duetact is pioglitazone and glimepiride, per the FDA Orange Book.
When does the Duetact patent expire?
The last patent listed for Duetact in the Orange Book expires June 8, 2028. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.