amisulpride · Lxo Ireland · NDA 209510
Barhemsys
Earliest generic entry, as listed · earliest of 2 marketed strengths
9 Feb 2038
Blocked by patent: US 11357753, US 12005042, US 12329740. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 8 unexpired
16 Orange Book listing rows for 8 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11357753 | use U-2754 · sets the listed date | 9 Feb 2038 |
| US 12005042 | use U-1744, U-2754, U-3467 | 9 Feb 2038 |
| US 12005042 listing row | use U-1744 · sets the listed date | 9 Feb 2038 |
| US 12005042 listing row | use U-2754 · sets the listed date | 9 Feb 2038 |
| US 12005042 listing row | use U-3467 · sets the listed date | 9 Feb 2038 |
| US 12329740 | use U-2754, U-3467 | 9 Feb 2038 |
| US 12329740 listing row | use U-2754 · sets the listed date | 9 Feb 2038 |
| US 12329740 listing row | use U-3467 · sets the listed date | 9 Feb 2038 |
| US 9084765 | use U-1744, U-2754, U-3467 | 26 Feb 2034 |
| US 9084765 listing row | use U-1744 | 26 Feb 2034 |
| US 9084765 listing row | use U-2754 | 26 Feb 2034 |
| US 9084765 listing row | use U-3467 | 26 Feb 2034 |
| US 10525033 | drug product | 10 Mar 2031 |
| US 12194022 | use U-1744, U-3467 | 10 Mar 2031 |
| US 12194022 listing row | use U-1744 | 10 Mar 2031 |
| US 12194022 listing row | use U-3467 | 10 Mar 2031 |
| US 9545426 | use U-1744, U-2754 | 10 Mar 2031 |
| US 9545426 listing row | use U-1744 | 10 Mar 2031 |
| US 9545426 listing row | use U-2754 | 10 Mar 2031 |
| US 9889118 | use U-1744, U-2754 | 10 Mar 2031 |
| US 9889118 listing row | use U-1744 | 10 Mar 2031 |
| US 9889118 listing row | use U-2754 | 10 Mar 2031 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209510 · 001 · RLD | solution, intravenous | 5MG/2ML (2.5MG/ML) | 9 Feb 2038 |
| 209510 · 002 · RLD | solution, intravenous | 10MG/4ML (2.5MG/ML) | 9 Feb 2038 |