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 one supplier. 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

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:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	May 6, 2009	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Apr 2, 2027
Regulatory Exclusivity Use:	INDICATED FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS
Patent:	⤷ Sign Up	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:	⤷ Sign Up	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	⤷ Sign Up	⤷ Sign Up
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-001	May 6, 2009	⤷ Sign Up	⤷ Sign Up
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-004	May 6, 2009	⤷ Sign Up	⤷ Sign Up
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-003	May 6, 2009	⤷ Sign Up	⤷ Sign Up
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-002	May 6, 2009	⤷ Sign Up	⤷ Sign Up
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-005	May 6, 2009	⤷ Sign Up	⤷ Sign Up
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-007	May 6, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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