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Last Updated: May 28, 2022

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. Two 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
Drug Prices for FANAPT

See drug prices for FANAPT

Recent Clinical Trials for FANAPT

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

SponsorPhase
Novartis PharmaceuticalsPhase 2
University of Colorado, DenverPhase 2
Novartis PharmaceuticalsPhase 4

See all FANAPT clinical trials

Pharmacology for FANAPT
Anatomical Therapeutic Chemical (ATC) Classes 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.

Patents protecting FANAPT

Methods for the administration of iloperidone
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-004 May 6, 2009 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-006 May 6, 2009 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-007 May 6, 2009 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 022192-006 May 6, 2009 See Plans and Pricing See Plans and Pricing
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-007 May 6, 2009 See Plans and Pricing See Plans and Pricing
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-001 May 6, 2009 See Plans and Pricing See Plans and Pricing
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-005 May 6, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FANAPT

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

Country Patent Number Title Estimated Expiration
European Patent Office 0963984 Hétéroarylpipéridines et pipérazines et leur utilisation comme antipsychotiques et analgésiques (Heteroarylpiperidines and piperazines and their use as antipsychotics and analgetics) See Plans and Pricing
Slovakia 279474 See Plans and Pricing
European Patent Office 0730452 See Plans and Pricing
Israel 111498 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Moodys
Mallinckrodt
Medtronic
McKesson

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