fingolimod lauryl sulfate · Cycle · NDA 214962
Tascenso Odt
Earliest generic entry, as listed · earliest of 2 marketed strengths
19 Jan 2036
Blocked by patent: US 10555902, US 10925829, US 9925138.
Listed patents · 3 unexpired
4 Orange Book listing rows for 3 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10555902 | use U-3268, U-3493 | 19 Jan 2036 |
| US 10555902 listing row | use U-3268 · sets the listed date | 19 Jan 2036 |
| US 10555902 listing row | use U-3493 · sets the listed date | 19 Jan 2036 |
| US 10925829 | drug product · sets the listed date | 19 Jan 2036 |
| US 9925138 | drug product · sets the listed date | 19 Jan 2036 |
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 |
|---|---|---|---|
| 214962 · 001 · RLD | tablet, orally disintegrating, oral | EQ 0.25MG BASE | 19 Jan 2036 |
| 214962 · 002 · RLD | tablet, orally disintegrating, oral | EQ 0.5MG BASE | 19 Jan 2036 |