amphetamine; amphetamine aspartate/dextroamphetamine sulfate · Tris Pharma Inc · NDA 210526
Dyanavel Xr 10
Earliest generic entry, as listed
11 Feb 2040
Blocked by patent: US 12458592. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12458592 | use U-3538 | 11 Feb 2040 |
| US 11590081 | product, use U-3538 | 24 Sep 2038 |
| US 12734132 | use U-3538 | 24 Sep 2038 |
| US 8337890 | product | 15 Mar 2027 |
| US 8747902 | product | 15 Mar 2027 |
| US 9675704 | product | 15 Mar 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 210526 · 002 · RLD | tablet, extended release, oral | 8MG;EQ 2MG BASE | 11 Feb 2040 |