Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Dow
Baxter
McKinsey
Medtronic
Boehringer Ingelheim
Mallinckrodt

Last Updated: June 24, 2022

Iloperidone - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

What are the generic drug sources for iloperidone and what is the scope of patent protection?

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
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 022192-001 May 6, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-002 May 6, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin Ltd ILOPERIDONE iloperidone TABLET;ORAL 206890-005 May 5, 2022 AB RX 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 022192-006 May 6, 2009 See Plans and Pricing See Plans and Pricing
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-007 May 6, 2009 See Plans and Pricing See Plans and Pricing
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-001 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

International Patents for iloperidone

Country Patent Number Title Estimated Expiration
Canada 3113166 METHODES D'ADMINISTRATION D'ILOPERIDONE (METHODS FOR THE ADMINISTRATION OF ILOPERIDONE) See Plans and Pricing
European Patent Office 2331098 MÉTHODES D'ADMINISTRATION D'ILOPÉRIDONE (METHODS FOR THE ADMINISTRATION OF ILOPERIDONE) See Plans and Pricing
Japan 5881597 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Colorcon
Mallinckrodt
McKinsey
Boehringer Ingelheim
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.