You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Dow
Baxter
McKinsey
Medtronic
Boehringer Ingelheim
Mallinckrodt

Last Updated: April 18, 2021

DrugPatentWatch Database Preview

Iloperidone - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« 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, and Taro Pharm Inds Ltd, and is included in three 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-seven 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
Recent Clinical Trials for iloperidone

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

SponsorPhase
Patient-Centered Outcomes Research InstitutePhase 4
Melissa DelbelloPhase 4
Janssen Scientific Affairs, LLCPhase 4

See all iloperidone clinical trials

Generic filers with tentative approvals for ILOPERIDONE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial2MGTABLET;ORAL
  Start Trial  Start Trial10MGTABLET;ORAL
  Start Trial  Start Trial8MGTABLET;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 NDA Submissiondate
FANAPT TABLET;ORAL iloperidone 022192 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 022192-004 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 022192-001 May 6, 2009 RX Yes Yes   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 022192-001 May 6, 2009 RX Yes Yes   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
>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 022192-007 May 6, 2009   Start Trial   Start Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-001 May 6, 2009   Start Trial   Start Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-006 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 022192-004 May 6, 2009   Start Trial   Start Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-002 May 6, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.