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Last Updated: July 15, 2024

FANAPT Drug Patent Profile


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Which patents cover Fanapt, and when can generic versions of Fanapt launch?

Fanapt is a drug marketed by Vanda Pharms Inc and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-nine patent family members in eight countries.

The generic ingredient in FANAPT is iloperidone. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iloperidone profile page.

DrugPatentWatch® Generic Entry Outlook for Fanapt

Fanapt was eligible for patent challenges on May 6, 2013.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (iloperidone), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for FANAPT
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Recent Clinical Trials for FANAPT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Vanda PharmaceuticalsPhase 2
University of Colorado, DenverPhase 2
Novartis PharmaceuticalsPhase 2

See all FANAPT clinical trials

Pharmacology for FANAPT
Paragraph IV (Patent) Challenges for FANAPT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FANAPT Tablets iloperidone 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg 022192 1 2013-05-06

US Patents and Regulatory Information for FANAPT

FANAPT is protected by nine US patents and one FDA Regulatory Exclusivity.

Patents protecting FANAPT

Methods for the administration of iloperidone
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6

Prediction of QT prolongation based on SNP genotype
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: DOSAGE MODIFICATION TO REDUCE THE RISK ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE

Method of treatment based on polymorphisms of the KCNQ1 gene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE

Method of predicting a predisposition to QT prolongation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE

Method of predicting a predisposition to QT prolongation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE

Method of predicting a predisposition to QT prolongation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE

Method of predicting a predisposition to QT prolongation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE

Methods for the administration of iloperidone
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE BEING TREATED WITH FLUOXETINE

Method of treatment based on polymorphisms of the KCNQ1 gene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE

FDA Regulatory Exclusivity protecting FANAPT

INDICATED FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-005 May 6, 2009 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-004 May 6, 2009 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-005 May 6, 2009 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-006 May 6, 2009 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-005 May 6, 2009 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-005 May 6, 2009 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-006 May 6, 2009 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for FANAPT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-001 May 6, 2009 ⤷  Sign Up ⤷  Sign Up
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-005 May 6, 2009 ⤷  Sign Up ⤷  Sign Up
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-002 May 6, 2009 ⤷  Sign Up ⤷  Sign Up
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-006 May 6, 2009 ⤷  Sign Up ⤷  Sign Up
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-007 May 6, 2009 ⤷  Sign Up ⤷  Sign Up
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-004 May 6, 2009 ⤷  Sign Up ⤷  Sign Up
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-003 May 6, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for FANAPT

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Vanda Pharmaceuticals Ltd Fanaptum iloperidone EMEA/H/C/004149
Treatment of schizophrenia
Refused no no no 2018-01-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for FANAPT

See the table below for patents covering FANAPT around the world.

Country Patent Number Title Estimated Expiration
Finland 942052 ⤷  Sign Up
Czech Republic 9002425 ⤷  Sign Up
Israel 111498 ⤷  Sign Up
Norway 177301 ⤷  Sign Up
Slovenia 2331098 ⤷  Sign Up
Philippines 30447 N-(aryloxyalkyl)hetero-arylpiperidines and heteroarylpiperazines and their use as antipsychotics and analgetics ⤷  Sign Up
Spain 2542967 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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