sotagliflozin · Lexicon Pharms Inc · NDA 216203
Inpefa
Earliest generic entry, as listed · earliest of 2 marketed strengths
7 Oct 2030
Blocked by patent: US 8217156.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8217156 | substance, product | 7 Oct 2030 |
| US 8476413 | substance, product, use U-3628 | 29 May 2028 |
| US 7781577 | substance, product, use U-3628 | 4 May 2028 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 26 May 2028 |
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 |
|---|---|---|---|
| 216203 · 001 · RLD | tablet, oral | 200MG | 7 Oct 2030 |
| 216203 · 002 · RLD | tablet, oral | 400MG | 7 Oct 2030 |