Details for New Drug Application (NDA): 022264
NDA 022264 describes INVEGA SUSTENNA, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the INVEGA SUSTENNA profile page.
The generic ingredient in INVEGA SUSTENNA is paliperidone palmitate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.
The generic ingredient in INVEGA SUSTENNA is paliperidone palmitate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.
Summary for 022264
| Tradename: | INVEGA SUSTENNA |
| Applicant: | Janssen Pharms |
| Ingredient: | paliperidone palmitate |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022264
Generic Entry Date for 022264*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 022264
Medical Subject Heading (MeSH) Categories for 022264
Suppliers and Packaging for NDA: 022264
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264 | NDA | Janssen Pharmaceuticals, Inc. | 50458-560 | 50458-560-01 | 1 SYRINGE in 1 KIT (50458-560-01) / .25 mL in 1 SYRINGE |
| INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264 | NDA | Janssen Pharmaceuticals, Inc. | 50458-561 | 50458-561-01 | 1 SYRINGE in 1 KIT (50458-561-01) / .5 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 39MG/0.25ML (39MG/0.25ML) | ||||
| Approval Date: | Jul 31, 2009 | TE: | RLD: | Yes | |||||
| Patent: | 9,439,906 | Patent Expiration: | Jan 26, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S) | ||||||||
| Patent: | 9,439,906 | Patent Expiration: | Jan 26, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S) | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 78MG/0.5ML (78MG/0.5ML) | ||||
| Approval Date: | Jul 31, 2009 | TE: | RLD: | Yes | |||||
| Patent: | 9,439,906 | Patent Expiration: | Jan 26, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S) | ||||||||
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