tofersen · Biogen Ma · NDA 215887
Qalsody
Earliest generic entry, as listed
1 Apr 2035
Blocked by patent: US 10385341, US 10669546, US 10968453.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10385341 | substance, product | 1 Apr 2035 |
| US 10669546 | use U-3575 | 1 Apr 2035 |
| US 10968453 | use U-3575 | 1 Apr 2035 |
Exclusivities · 2 unexpired
| ODE-432 | orphan drug (7 years) | 25 Apr 2030 |
| NCE | new chemical entity (5 years) | 25 Apr 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215887 · 001 · RLD | solution, intrathecal | 100MG/15ML (6.7MG/ML) | 1 Apr 2035 |