methylphenidate hydrochloride · Osmotica Pharm Us · NDA 216117
Relexxii
Earliest generic entry, as listed · earliest of 7 marketed strengths
3 Feb 2037
Blocked by patent: US 10265308, US 10695336, US 9707217, US 9827234, US 9855258.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10265308 | drug product, use U-4032 · sets the listed date | 3 Feb 2037 |
| US 10695336 | use U-4032 · sets the listed date | 3 Feb 2037 |
| US 9707217 | drug product · sets the listed date | 3 Feb 2037 |
| US 9827234 | use U-4032 · sets the listed date | 3 Feb 2037 |
| US 9855258 | drug product, use U-4032 · sets the listed date | 3 Feb 2037 |
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 · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216117 · 001 · RLD | tablet, extended release, oral | 18MG | 3 Feb 2037 |
| 216117 · 002 · RLD | tablet, extended release, oral | 27MG | 3 Feb 2037 |
| 216117 · 003 · RLD | tablet, extended release, oral | 36MG | 3 Feb 2037 |
| 216117 · 004 · RLD | tablet, extended release, oral | 45MG | 3 Feb 2037 |
| 216117 · 005 · RLD | tablet, extended release, oral | 54MG | 3 Feb 2037 |
| 216117 · 006 · RLD | tablet, extended release, oral | 63MG | 3 Feb 2037 |
| 216117 · 007 · RLD | tablet, extended release, oral | 72MG | 3 Feb 2037 |