methylphenidate hydrochloride · Nextwave · NDA 202100
Quillivant Xr
Earliest generic entry, as listed
15 Feb 2031
Blocked by patent: US 8287903, US 8465765, US 8563033, US 8778390, US 8956649, US 9040083.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8287903 | drug product · sets the listed date | 15 Feb 2031 |
| US 8465765 | drug product, use U-1415 · sets the listed date | 15 Feb 2031 |
| US 8563033 | drug product, use U-1415 · sets the listed date | 15 Feb 2031 |
| US 8778390 | drug product, use U-1543 · sets the listed date | 15 Feb 2031 |
| US 8956649 | drug product, use U-1665 · sets the listed date | 15 Feb 2031 |
| US 9040083 | drug product · sets the listed date | 15 Feb 2031 |
| US 8062667 | drug product | 29 Mar 2029 |
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 |
|---|---|---|---|
| 202100 · 001 · RLD | for suspension, extended release, oral | 5MG/ML | 15 Feb 2031 |