milsaperidone · Vanda Pharms Inc · NDA 220358
Bysanti
Earliest generic entry, as listed · earliest of 7 marketed strengths
31 May 2044
Blocked by patent: US 12478619. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 10 unexpired
20 Orange Book listing rows for 10 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12478619 | use U-4434, U-4435 | 31 May 2044 |
| US 12478619 listing row | use U-4434 · sets the listed date | 31 May 2044 |
| US 12478619 listing row | use U-4435 · sets the listed date | 31 May 2044 |
| US 9074254 | use U-4436, U-4437 | 28 Dec 2031 |
| US 9074254 listing row | use U-4436 | 28 Dec 2031 |
| US 9074254 listing row | use U-4437 | 28 Dec 2031 |
| US 9074256 | use U-4436, U-4437 | 10 Feb 2031 |
| US 9074256 listing row | use U-4436 | 10 Feb 2031 |
| US 9074256 listing row | use U-4437 | 10 Feb 2031 |
| US 9072742 | use U-4436, U-4437 | 16 Jan 2031 |
| US 9072742 listing row | use U-4436 | 16 Jan 2031 |
| US 9072742 listing row | use U-4437 | 16 Jan 2031 |
| US 9074255 | use U-4436, U-4437 | 17 Dec 2030 |
| US 9074255 listing row | use U-4436 | 17 Dec 2030 |
| US 9074255 listing row | use U-4437 | 17 Dec 2030 |
| US 8999638 | use U-4436, U-4437 | 28 Oct 2030 |
| US 8999638 listing row | use U-4436 | 28 Oct 2030 |
| US 8999638 listing row | use U-4437 | 28 Oct 2030 |
| US 12606869 | use U-4506, U-4507 | 22 Sep 2030 |
| US 12606869 listing row | use U-4506 | 22 Sep 2030 |
| US 12606869 listing row | use U-4507 | 22 Sep 2030 |
| US 10563259 | use U-4436, U-4437 | 24 Jul 2030 |
| US 10563259 listing row | use U-4436 | 24 Jul 2030 |
| US 10563259 listing row | use U-4437 | 24 Jul 2030 |
| US 9157121 | use U-4436, U-4437 | 5 Apr 2030 |
| US 9157121 listing row | use U-4436 | 5 Apr 2030 |
| US 9157121 listing row | use U-4437 | 5 Apr 2030 |
| US 10570453 | use U-4436, U-4437 | 28 Mar 2028 |
| US 10570453 listing row | use U-4436 | 28 Mar 2028 |
| US 10570453 listing row | use U-4437 | 28 Mar 2028 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 20 Feb 2031 |
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 |
|---|---|---|---|
| 220358 · 001 · RLD | tablet, oral | 1MG | 31 May 2044 |
| 220358 · 002 · RLD | tablet, oral | 2MG | 31 May 2044 |
| 220358 · 003 · RLD | tablet, oral | 4MG | 31 May 2044 |
| 220358 · 004 · RLD | tablet, oral | 6MG | 31 May 2044 |
| 220358 · 005 · RLD | tablet, oral | 8MG | 31 May 2044 |
| 220358 · 006 · RLD | tablet, oral | 10MG | 31 May 2044 |
| 220358 · 007 · RLD | tablet, oral | 12MG | 31 May 2044 |