alogliptin benzoate; metformin hydrochloride · Takeda Pharms Usa · NDA 203414
Kazano
Earliest generic entry, as listed · earliest of 2 marketed strengths
24 May 2029
Blocked by patent: US 8900638.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8900638 | drug product · sets the listed date | 24 May 2029 |
| US 7807689 | drug substance, drug product, use U-1337 | 27 Jun 2028 |
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 |
|---|---|---|---|
| 203414 · 001 · RLD | tablet, oral | EQ 12.5MG BASE;500MG | 24 May 2029 |
| 203414 · 002 · RLD | tablet, oral | EQ 12.5MG BASE;1GM | 24 May 2029 |
Expired or delisted (1)
- M-300 · 27 Jul 2026