Last Updated: November 13, 2026

Details for Patent: 9,074,254

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Which drugs does patent 9,074,254 protect, and when does it expire?

Patent 9,074,254 protects BYSANTI and FANAPT and is included in two NDAs.

This patent has five patent family members in four countries.

Summary for Patent: 9,074,254
Title:Method of predicting a predisposition to QT prolongation
Abstract:The present invention describes an association between genetic polymorphisms in the ceramide kinase-like (CERKL) gene and a predisposition to prolongation of the QT interval, and provides related methods for the prediction of such a predisposition, the administration of QT interval-prolonging compounds to individuals having such a predisposition, and determining whether a compound is capable of inducing QT prolongation.
Inventor(s):Christian Lavedan, Simona Volpi, Louis Licamele, Kendra Tomino Mack, Callie Michelle Heaton
Assignee: Vanda Pharmaceuticals Inc
Application Number:US12/593,419
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,074,254
Patent Claim Types:
see list of patent claims
Use;

Drugs Protected by US Patent 9,074,254

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Vanda Pharms Inc BYSANTI milsaperidone TABLET;ORAL 220358-001 Feb 20, 2026 RX Yes Yes 9,074,254 ⤷  Start Trial METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING MILSAPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION ⤷  Start Trial
Vanda Pharms Inc BYSANTI milsaperidone TABLET;ORAL 220358-001 Feb 20, 2026 RX Yes Yes 9,074,254 ⤷  Start Trial METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING MILSAPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION ⤷  Start Trial
Vanda Pharms Inc BYSANTI milsaperidone TABLET;ORAL 220358-002 Feb 20, 2026 RX Yes No 9,074,254 ⤷  Start Trial METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING MILSAPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION ⤷  Start Trial
Vanda Pharms Inc BYSANTI milsaperidone TABLET;ORAL 220358-002 Feb 20, 2026 RX Yes No 9,074,254 ⤷  Start Trial METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING MILSAPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION ⤷  Start Trial
Vanda Pharms Inc BYSANTI milsaperidone TABLET;ORAL 220358-003 Feb 20, 2026 RX Yes No 9,074,254 ⤷  Start Trial METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING MILSAPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 9,074,254

PCT Information
PCT FiledMarch 28, 2008PCT Application Number:PCT/US2008/058791
PCT Publication Date:October 09, 2008PCT Publication Number: WO2008/121899

International Family Members for US Patent 9,074,254

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2134873 ⤷  Start Trial
Spain 2542967 ⤷  Start Trial
Japan 2010522773 ⤷  Start Trial
Japan 5586094 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2008121899 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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