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Generated: November 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022192

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NDA 022192 describes FANAPT, which is a drug marketed by Vanda Pharms Inc and is included in one NDA. It is available from two suppliers. There are nine patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FANAPT profile page.

The generic ingredient in FANAPT is iloperidone. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iloperidone profile page.
Summary for 022192
Tradename:FANAPT
Applicant:Vanda Pharms Inc
Ingredient:iloperidone
Patents:9
Formulation / Manufacturing:see details
Pharmacology for NDA: 022192
Suppliers and Packaging for NDA: 022192
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FANAPT iloperidone TABLET;ORAL 022192 NDA Vanda Pharmaceuticals Inc. 43068-101 43068-101-02 60 TABLET in 1 BOTTLE (43068-101-02)
FANAPT iloperidone TABLET;ORAL 022192 NDA Vanda Pharmaceuticals Inc. 43068-102 43068-102-02 60 TABLET in 1 BOTTLE (43068-102-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:May 6, 2009TE:ABRLD:Yes
Regulatory Exclusivity Expiration:May 26, 2019
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING REGARDING THE ADDITION OF MAINTENANCE TREATMENT IN PATIENTS WITH SCHIZOPHRENIA
Patent:➤ Try a Free TrialPatent Expiration:Nov 2, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6
Patent:➤ Try a Free TrialPatent Expiration:Aug 31, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:DOSAGE MODIFICATION TO REDUCE THE RISK ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE

Expired US Patents for NDA 022192

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-004 May 6, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-001 May 6, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Vanda Pharms Inc FANAPT iloperidone TABLET;ORAL 022192-005 May 6, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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McKesson
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Medtronic
Express Scripts
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Boehringer Ingelheim
Chinese Patent Office
Mallinckrodt
US Army

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