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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 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. Four suppliers are listed for this compound. Additional details are available on the iloperidone profile page.
The generic ingredient in FANAPT is iloperidone. There are eight drug master file entries for this compound. Four 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 |
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) |
Paragraph IV (Patent) Challenges for 022192
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FANAPT | TABLET;ORAL | iloperidone | 022192 | 2013-05-06 |
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: | May 26, 2019 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE LABELING REGARDING THE ADDITION OF MAINTENANCE TREATMENT IN PATIENTS WITH SCHIZOPHRENIA | ||||||||
| Patent: | Start 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: | Start 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-003 | 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 | 022192-005 | May 6, 2009 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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