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Last Updated: December 13, 2024

Iloperidone - Generic Drug Details


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What are the generic drug sources for iloperidone and what is the scope of freedom to operate?

Iloperidone is the generic ingredient in two branded drugs marketed by Vanda Pharms Inc, Inventia, Lupin Ltd, and Taro, and is included in four NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Iloperidone has fifty-nine patent family members in eight countries.

There are eight drug master file entries for iloperidone. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for iloperidone
Recent Clinical Trials for iloperidone

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

SponsorPhase
Vanda PharmaceuticalsPhase 2
Melissa DelbelloPhase 4
Patient-Centered Outcomes Research InstitutePhase 4

See all iloperidone clinical trials

Generic filers with tentative approvals for ILOPERIDONE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up10MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up8MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up6MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for iloperidone
Anatomical Therapeutic Chemical (ATC) Classes for iloperidone
Paragraph IV (Patent) Challenges for ILOPERIDONE
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 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 022192-002 May 6, 2009 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Taro ILOPERIDONE iloperidone TABLET;ORAL 207098-002 Jul 22, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Taro ILOPERIDONE iloperidone TABLET;ORAL 207098-003 Jul 22, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-007 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 iloperidone

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

EU/EMA Drug Approvals for iloperidone

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 iloperidone

Country Patent Number Title Estimated Expiration
European Patent Office 2331098 MÉTHODES D'ADMINISTRATION D'ILOPÉRIDONE (METHODS FOR THE ADMINISTRATION OF ILOPERIDONE) ⤷  Sign Up
Japan 5586094 ⤷  Sign Up
European Patent Office 3492081 PROCÉDÉS D'ADMINISTRATION DE L'ILOPÉRIDONE (METHODS FOR THE ADMINISTRATION OF ILOPERIDONE) ⤷  Sign Up
Spain 2688476 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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