Bysanti is a drug owned by Vanda Pharmaceuticals Inc. It is protected by 9 US drug patents filed in 2026 out of which none have expired yet. Bysanti's patents will be open to challenges from 20 February, 2030. Based on its patents and exclusivities, its generic launch date is estimated to be May 31, 2044. Details of Bysanti's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12478619 | Method Of Treatment With Milsaperidone |
May, 2044
(18 years from now) | Active |
| US9074254 | Method of predicting a predisposition to QT prolongation |
Dec, 2031
(5 years from now) | Active |
| US9074256 | Method of predicting a predisposition to QT prolongation |
Feb, 2031
(4 years from now) | Active |
| US9072742 | Method of predicting a predisposition to QT prolongation |
Jan, 2031
(4 years from now) | Active |
| US9074255 | Method of predicting a predisposition to QT prolongation |
Dec, 2030
(4 years from now) | Active |
| US8999638 | Method of treatment based on polymorphisms of the KCNQ1 gene |
Oct, 2030
(4 years from now) | Active |
| US10563259 | Method Of Treatment Based On Polymorphisms Of The Kcnq1 Gene |
Jul, 2030
(4 years from now) | Active |
| US9157121 | Method of treatment based on polymorphisms of the KCNQ1 gene |
Apr, 2030
(3 years from now) | Active |
| US10570453 | Method Of Predicting A Predisposition To Qt Prolongation |
Mar, 2028
(1 year, 10 months from now) | Active |
FDA has granted several exclusivities to Bysanti. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Bysanti, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Bysanti.
Exclusivity Information
Bysanti holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Bysanti's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 20, 2031 |
US patents provide insights into the exclusivity only within the United States, but
Bysanti is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Bysanti's family patents as well as insights into
ongoing legal events
on those patents.
Bysanti's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Bysanti's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 31, 2044 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Bysanti Generics:
There are no approved generic versions for Bysanti as of now.
About Bysanti
Bysanti is a drug owned by Vanda Pharmaceuticals Inc. Bysanti uses Milsaperidone as an active ingredient. Bysanti was launched by Vanda in 2026.
Approval Date:
Bysanti was approved by FDA for market use on 20 February, 2026.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Bysanti is 20 February, 2026, its NCE-1 date is estimated to be 20 February, 2030.
Active Ingredient:
Bysanti uses Milsaperidone as the active ingredient. Check out other Drugs and Companies using Milsaperidone ingredient
Dosage:
Bysanti is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG | TABLET | Prescription | ORAL |
| 4MG | TABLET | Prescription | ORAL |
| 2MG | TABLET | Prescription | ORAL |
| 1MG | TABLET | Prescription | ORAL |
| 12MG | TABLET | Prescription | ORAL |
| 8MG | TABLET | Prescription | ORAL |
| 6MG | TABLET | Prescription | ORAL |