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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 ten 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. Two suppliers are listed for this compound. There are seven tentative approvals for this compound. Additional details are available on the iloperidone profile page.

Summary for NDA: 022192

Tradename:
FANAPT
Applicant:
Vanda Pharms Inc
Ingredient:
iloperidone
Patents:10
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 Novartis Pharmaceuticals Corporation 0078-0595 0078-0595-20 60 TABLET in 1 BOTTLE (0078-0595-20)
FANAPT
iloperidone
TABLET;ORAL 022192 NDA Novartis Pharmaceuticals Corporation 0078-0596 0078-0596-20 60 TABLET in 1 BOTTLE (0078-0596-20)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:May 6, 2009TE:RLD:Yes
Patent:8,999,638Patent Expiration:Oct 28, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE
Patent:9,072,742Patent Expiration:Jan 16, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE
Patent:9,074,254Patent Expiration:Dec 28, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE

Expired Orange Book Patents for NDA: 022192

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vanda Pharms Inc
FANAPT
iloperidone
TABLET;ORAL022192-007May 6, 2009RE39198► subscribe
Vanda Pharms Inc
FANAPT
iloperidone
TABLET;ORAL022192-003May 6, 2009RE39198► subscribe
Vanda Pharms Inc
FANAPT
iloperidone
TABLET;ORAL022192-001May 6, 2009RE39198► subscribe
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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.

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