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Iloperidoneis 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.
Summary for iloperidone
|Drug Master File Entries:||8|
|Finished Product Suppliers / Packagers:||2|
|Raw Ingredient (Bulk) Api Vendors:||121|
|Formulation / Manufacturing:||see details|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for iloperidone|
|What excipients (inactive ingredients) are in iloperidone?||iloperidone excipients list|
|DailyMed Link:||iloperidone at DailyMed|
Recent Clinical Trials for iloperidone
Identify potential brand extensions & 505(b)(2) entrants
|Vanda Pharmaceuticals||Phase 2|
|Melissa Delbello||Phase 4|
|Patient-Centered Outcomes Research Institute||Phase 4|
Generic filers with tentative approvals for ILOPERIDONE
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
|Drug Class||Atypical Antipsychotic |
|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|
|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|
|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
|>Company||>Drugname||>Inn||>Product Number / Indication||>Status||>Generic||>Biosimilar||>Orphan||>Marketing Authorisation||>Marketing Refusal|
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