dextroamphetamine · Noven Pharms Inc · NDA 215401
Xelstrym
Earliest generic entry, as listed · earliest of 4 marketed strengths
6 Jan 2042
Blocked by patent: US 11559501.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11559501 | drug product · sets the listed date | 6 Jan 2042 |
| US 12678504 | drug product, use U-4583 | 12 Mar 2034 |
| US 9456993 | drug product, use U-3340 | 24 Oct 2033 |
| US 9474722 | drug product | 24 Oct 2033 |
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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215401 · 001 · RLD | system, transdermal | 4.5MG/9HR | 6 Jan 2042 |
| 215401 · 002 · RLD | system, transdermal | 9MG/9HR | 6 Jan 2042 |
| 215401 · 003 · RLD | system, transdermal | 13.5MG/9HR | 6 Jan 2042 |
| 215401 · 004 · RLD | system, transdermal | 18MG/9HR | 6 Jan 2042 |