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Generated: May 27, 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	N	43068-101-02
FANAPT	iloperidone	TABLET;ORAL	022192	NDA	Vanda Pharmaceuticals Inc.	43068-102	N	43068-102-02

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	May 6, 2009	TE:	AB	RLD:	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 Trial	Patent Expiration:	Nov 2, 2027	Product 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 Trial	Patent Expiration:	Aug 31, 2030	Product 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-006	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
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-002	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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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 verifification 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.