Details for New Drug Application (NDA): 022264
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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 are thirty-eight drug master file entries for this compound. Two 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 are thirty-eight drug master file entries for this compound. Two 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 |
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: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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) | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 26, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS | ||||||||
Expired US Patents for NDA 022264
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-004 | Jul 31, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-005 | Jul 31, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-004 | Jul 31, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-002 | Jul 31, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-001 | Jul 31, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-002 | Jul 31, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-001 | Jul 31, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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