glimepiride; pioglitazone hydrochloride · Takeda Pharms Usa · NDA 021925
Duetact
Earliest generic entry, as listed · earliest of 2 marketed strengths
8 Jun 2028
Blocked by patent: US 8071130.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8071130 | product | 8 Jun 2028 |
| US 7700128 | product | 30 Jan 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021925 · 001 · RLD | tablet, oral | 2MG;30MG | 8 Jun 2028 |
| 021925 · 002 · RLD | tablet, oral | 4MG;30MG | 8 Jun 2028 |