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Last Updated: November 29, 2022

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 Pharm Inds Ltd, 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. Two suppliers are listed for this compound. There is one tentative approval for this compound.

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
See Plans and PricingSee Plans and Pricing10MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing8MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing6MGTABLET;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
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
Taro Pharm Inds Ltd ILOPERIDONE iloperidone TABLET;ORAL 207098-006 Jul 22, 2019 DISCN No 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
Inventia ILOPERIDONE iloperidone TABLET;ORAL 207231-004 Nov 28, 2016 DISCN No 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 iloperidone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-002 May 6, 2009 See Plans and Pricing See Plans and Pricing
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-004 May 6, 2009 See Plans and Pricing See Plans and Pricing
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-006 May 6, 2009 See Plans and Pricing See Plans and Pricing
>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

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