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Last Updated: March 28, 2024

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.
Summary for 022264
Tradename:INVEGA SUSTENNA
Applicant:Janssen Pharms
Ingredient:paliperidone palmitate
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 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:RXDosage:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULARStrength39MG/0.25ML (39MG/0.25ML)
Approval Date:Jul 31, 2009TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jan 26, 2031Product 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:⤷  Try a TrialPatent Expiration:Jan 26, 2031Product 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:⤷  Try a TrialPatent Expiration:Jan 26, 2031Product 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 022264-003 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-001 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-002 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-004 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-002 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-002 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-005 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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