Orange Book product · Brand (NDA)
BYSANTI
MILSAPERIDONE
At a glance
Feb 20, 2026
Approved
Brand (NDA)
Application
Not listed
TE code
20
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 20, 2026
4 mo ago
Today
Patent 10570453 expires
Listed method-of-use patent (U-4436) expiration.
Mar 28, 2028
in 1 yr 10 mo
Patent 10570453 expires
Listed method-of-use patent (U-4437) expiration.
Mar 28, 2028
in 1 yr 10 mo
Patent 9157121 expires
Listed method-of-use patent (U-4436) expiration.
Apr 05, 2030
in 3 yr 10 mo
Patent 9157121 expires
Listed method-of-use patent (U-4437) expiration.
Apr 05, 2030
in 3 yr 10 mo
Patent 10563259 expires
Listed method-of-use patent (U-4436) expiration.
Jul 24, 2030
in 4 yr 2 mo
Patent 10563259 expires
Listed method-of-use patent (U-4437) expiration.
Jul 24, 2030
in 4 yr 2 mo
Patent 12606869 expires
Listed method-of-use patent (U-4506) expiration.
Sep 22, 2030
in 4 yr 4 mo
Patent 12606869 expires
Listed method-of-use patent (U-4507) expiration.
Sep 22, 2030
in 4 yr 4 mo
Patent 8999638 expires
Listed method-of-use patent (U-4436) expiration.
Oct 28, 2030
in 4 yr 5 mo
Patent 8999638 expires
Listed method-of-use patent (U-4437) expiration.
Oct 28, 2030
in 4 yr 5 mo
Patent 9074255 expires
Listed method-of-use patent (U-4436) expiration.
Dec 17, 2030
in 4 yr 7 mo
Patent 9074255 expires
Listed method-of-use patent (U-4437) expiration.
Dec 17, 2030
in 4 yr 7 mo
Patent 9072742 expires
Listed method-of-use patent (U-4436) expiration.
Jan 16, 2031
in 4 yr 8 mo
Patent 9072742 expires
Listed method-of-use patent (U-4437) expiration.
Jan 16, 2031
in 4 yr 8 mo
Patent 9074256 expires
Listed method-of-use patent (U-4436) expiration.
Feb 10, 2031
in 4 yr 9 mo
Patent 9074256 expires
Listed method-of-use patent (U-4437) expiration.
Feb 10, 2031
in 4 yr 9 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Feb 20, 2031
in 4 yr 9 mo
Patent 9074254 expires
Listed method-of-use patent (U-4436) expiration.
Dec 28, 2031
in 5 yr 7 mo
Patent 9074254 expires
Listed method-of-use patent (U-4437) expiration.
Dec 28, 2031
in 5 yr 7 mo
Patent 12478619 expires
Listed method-of-use patent (U-4434) expiration.
May 31, 2044
in 18 yr 3 mo
Patent 12478619 expires
Listed method-of-use patent (U-4435) expiration.
May 31, 2044
in 18 yr 3 mo
Pharmaceutical detail
Active ingredient
MILSAPERIDONE
Strength
1MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 220358
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NCENew chemical entity exclusivity (5 years)
Feb 20, 2031
in 4 yr 9 mo
Listed patents (20)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10570453 | Mar 28, 2028 | in 1 yr 10 mo | U-4436 |
| 10570453 | Mar 28, 2028 | in 1 yr 10 mo | U-4437 |
| 9157121 | Apr 05, 2030 | in 3 yr 10 mo | U-4436 |
| 9157121 | Apr 05, 2030 | in 3 yr 10 mo | U-4437 |
| 10563259 | Jul 24, 2030 | in 4 yr 2 mo | U-4436 |
| 10563259 | Jul 24, 2030 | in 4 yr 2 mo | U-4437 |
| 12606869 | Sep 22, 2030 | in 4 yr 4 mo | U-4506 |
| 12606869 | Sep 22, 2030 | in 4 yr 4 mo | U-4507 |
| 8999638 | Oct 28, 2030 | in 4 yr 5 mo | U-4436 |
| 8999638 | Oct 28, 2030 | in 4 yr 5 mo | U-4437 |
| 9074255 | Dec 17, 2030 | in 4 yr 7 mo | U-4436 |
| 9074255 | Dec 17, 2030 | in 4 yr 7 mo | U-4437 |
| 9072742 | Jan 16, 2031 | in 4 yr 8 mo | U-4436 |
| 9072742 | Jan 16, 2031 | in 4 yr 8 mo | U-4437 |
| 9074256 | Feb 10, 2031 | in 4 yr 9 mo | U-4436 |
| 9074256 | Feb 10, 2031 | in 4 yr 9 mo | U-4437 |
| 9074254 | Dec 28, 2031 | in 5 yr 7 mo | U-4436 |
| 9074254 | Dec 28, 2031 | in 5 yr 7 mo | U-4437 |
| 12478619 | May 31, 2044 | in 18 yr 3 mo | U-4434 |
| 12478619 | May 31, 2044 | in 18 yr 3 mo | U-4435 |
