The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Bysanti
Milsaperidone · MILSAPERIDONE 12 mg/1 · Tablet · Oral · Vanda Pharmaceuticals Inc.
NDC 43068-0712-02 · 60 TABLET in 1 BOTTLE · NDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Regulatory
- Application
- NDA220358
- TE code
- —
- Approval date
- Feb 20, 2026
- Patents / exclusivity
- 70 patents, 7 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | NCE | Feb 20, 2031 |
| exclusivity | NCE | Feb 20, 2031 |
| exclusivity | NCE | Feb 20, 2031 |
| exclusivity | NCE | Feb 20, 2031 |
| exclusivity | NCE | Feb 20, 2031 |
| exclusivity | NCE | Feb 20, 2031 |
| exclusivity | NCE | Feb 20, 2031 |
| patent | 12478619 | May 31, 2044 |
| patent | 12478619 | May 31, 2044 |
| patent | 12478619 | May 31, 2044 |
| patent | 12478619 | May 31, 2044 |
| patent | 12478619 | May 31, 2044 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Milsaperidone (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Vanda Pharmaceuticals Inc. | MILSAPERIDONE 1 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Vanda Pharmaceuticals Inc. | MILSAPERIDONE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Vanda Pharmaceuticals Inc. | MILSAPERIDONE 12 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Vanda Pharmaceuticals Inc. | MILSAPERIDONE 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Vanda Pharmaceuticals Inc. | MILSAPERIDONE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Vanda Pharmaceuticals Inc. | MILSAPERIDONE 8 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Vanda Pharmaceuticals Inc. | MILSAPERIDONE 6 mg/1 | Jul 15, 2026 | Aug 28, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Bysanti — NDC 43068-0712-02," retrieved September 3, 2026, https://drugdashboards.com/drug/43068071202.
Free to cite with attribution — see how the data is put together.