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Last Updated: February 28, 2021

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FANAPT Drug 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-seven 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.

US ANDA Litigation and Generic Entry Outlook for Fanapt

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

There have been seven 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

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

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

See all FANAPT clinical trials

Pharmacology for FANAPT
Paragraph IV (Patent) Challenges for FANAPT
Tradename Dosage Ingredient NDA Submissiondate
FANAPT TABLET;ORAL iloperidone 022192 2013-05-06

US Patents and Regulatory Information for FANAPT

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   Start Trial   Start Trial   Start Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-004 May 6, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-006 May 6, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-007 May 6, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-005 May 6, 2009 RX Yes No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-005 May 6, 2009   Start Trial   Start Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-007 May 6, 2009   Start Trial   Start Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-003 May 6, 2009   Start Trial   Start Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-004 May 6, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Moodys
Mallinckrodt
Medtronic
McKesson

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