amantadine hydrochloride · Supernus Pharms · NDA 209410
Osmolex Er
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10213393, US 10213394, US 10500170, US 10500171, US 10500172, US 10512617, US 11890261. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 9 unexpired
10 Orange Book listing rows for 9 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10213393 | use U-20 · sets the listed date | 15 Feb 2038 |
| US 10213394 | use U-2497 · sets the listed date | 15 Feb 2038 |
| US 10500170 | use U-20 · sets the listed date | 15 Feb 2038 |
| US 10500171 | use U-2497 · sets the listed date | 15 Feb 2038 |
| US 10500172 | use U-2497 · sets the listed date | 15 Feb 2038 |
| US 10512617 | use U-2497 · sets the listed date | 15 Feb 2038 |
| US 11890261 | use U-2497 · sets the listed date | 15 Feb 2038 |
| US 8252331 | drug product | 13 Mar 2030 |
| US 8389578 | use U-219, U-3054 | 22 Jan 2028 |
| US 8389578 listing row | use U-219 | 22 Jan 2028 |
| US 8389578 listing row | use U-3054 | 22 Jan 2028 |
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 |
|---|---|---|---|
| 209410 · 001 · RLD · discontinued | tablet, extended release, oral | EQ 129MG BASE | 15 Feb 2038 |
| 209410 · 002 · RLD · discontinued | tablet, extended release, oral | EQ 193MG BASE | 15 Feb 2038 |
| 209410 · 003 · RLD · discontinued | tablet, extended release, oral | EQ 258MG BASE | 15 Feb 2038 |
| 209410 · 004 · RLD · discontinued | tablet, extended release, oral | EQ 161MG BASE | 15 Feb 2038 |