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Last Updated: March 28, 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
Drug Prices for FANAPT

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Recent Clinical Trials for FANAPT

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

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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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-004 May 6, 2009 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-006 May 6, 2009 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-007 May 6, 2009 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-005 May 6, 2009 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-006 May 6, 2009 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-002 May 6, 2009 ⤷  Try a Trial ⤷  Try a Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-004 May 6, 2009 ⤷  Try a Trial ⤷  Try a Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-003 May 6, 2009 ⤷  Try a Trial ⤷  Try a Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-005 May 6, 2009 ⤷  Try a Trial ⤷  Try a Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-006 May 6, 2009 ⤷  Try a Trial ⤷  Try a Trial
>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
Israel 103622 Heteroarylpiperidines pyrrolidines and piperazines and antipsychotic and analgetic pharmaceutical compositions containing them ⤷  Try a Trial
European Patent Office 2198048 PRÉDICTION DE LA PROLONGATION DU QT EN FONCTION DU GÉNOTYPE SNP (PREDICTION OF QT PROLONGATION BASED ON SNP GENOTYPE) ⤷  Try a Trial
European Patent Office 1110954 ⤷  Try a Trial
Japan 2012522534 ⤷  Try a Trial
Hungary T58720 ⤷  Try a Trial
Japan H0363263 N-(ARYLOXYALKYL)HETEROARYL PIPERIDINE AND N- (ARYLOXYALKYL) HETEROARYL PIPERAZINE ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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