methylphenidate · Neos Theraps Inc · NDA 205489
Cotempla Xr-Odt
Earliest generic entry, as listed · earliest of 3 marketed strengths
25 Jan 2038
Blocked by patent: US 11166947. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11166947 | use U-3299 · sets the listed date | 25 Jan 2038 |
| US 9072680 | drug product | 28 Jun 2032 |
| US 9089496 | drug product | 28 Jun 2032 |
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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205489 · 001 · RLD | tablet, orally disintegrating, extended release, oral | 8.6MG | 25 Jan 2038 |
| 205489 · 002 · RLD | tablet, orally disintegrating, extended release, oral | 17.3MG | 25 Jan 2038 |
| 205489 · 003 · RLD | tablet, orally disintegrating, extended release, oral | 25.9MG | 25 Jan 2038 |
| 205489 · 004 · RLD · discontinued | tablet, orally disintegrating, extended release, oral | 34.6MG | open |
Expired or delisted (1)
- US 8840924 · product · 5 Jun 2026