safinamide mesylate · Mdd Us · NDA 207145
Xadago
Earliest generic entry, as listed · earliest of 2 marketed strengths
21 Mar 2031
Blocked by patent: US 8283380. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8283380 | use U-1993 | 21 Mar 2031 |
| US 8076515 | substance, product, use U-1993 | 10 Dec 2028 |
| US 8278485 | substance, use U-1993 | 8 Jun 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 |
|---|---|---|---|
| 207145 · 001 · RLD | tablet, oral | EQ 50MG BASE | 21 Mar 2031 |
| 207145 · 002 · RLD | tablet, oral | EQ 100MG BASE | 21 Mar 2031 |