amphetamine; amphetamine aspartate/dextroamphetamine sulfate · Tris Pharma Inc · NDA 208147
Dyanavel Xr
Earliest generic entry, as listed
7 Sep 2036
Blocked by patent: US 11590228.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11590228 | product, use U-3538 | 7 Sep 2036 |
| US 8062667 | product | 29 Mar 2029 |
| US 10086087 | product | 15 Mar 2027 |
| US 8597684 | product | 15 Mar 2027 |
| US 8747902 | product | 15 Mar 2027 |
| US 8883217 | product | 15 Mar 2027 |
| US 9675703 | 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 |
|---|---|---|---|
| 208147 · 001 · RLD | suspension, extended release, oral | 2MG/ML;EQ 0.5MG BASE/ML | 7 Sep 2036 |