methylphenidate hydrochloride · Nextwave Pharms · NDA 207960
Quillichew Er
Earliest generic entry, as listed · earliest of 3 marketed strengths
14 Aug 2033
Blocked by patent: US 10857143, US 11103494, US 11103495, US 11633389, US 8999386, US 9295642, US 9545399, US 9844544.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10857143 | drug product, use U-2993 · sets the listed date | 14 Aug 2033 |
| US 11103494 | drug product · sets the listed date | 14 Aug 2033 |
| US 11103495 | drug product, use U-2993 · sets the listed date | 14 Aug 2033 |
| US 11633389 | drug product · sets the listed date | 14 Aug 2033 |
| US 8999386 | drug product · sets the listed date | 14 Aug 2033 |
| US 9295642 | drug product, use U-1827 · sets the listed date | 14 Aug 2033 |
| US 9545399 | drug product, use U-1827 · sets the listed date | 14 Aug 2033 |
| US 9844544 | drug product, use U-2203 · sets the listed date | 14 Aug 2033 |
| US 8287903 | drug product | 15 Feb 2031 |
| US 8202537 | drug 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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 207960 · 001 · RLD | tablet, extended release, chewable, oral | 20MG | 14 Aug 2033 |
| 207960 · 002 · RLD | tablet, extended release, chewable, oral | 30MG | 14 Aug 2033 |
| 207960 · 003 · RLD | tablet, extended release, chewable, oral | 40MG | 14 Aug 2033 |