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Last Updated: December 6, 2019

DrugPatentWatch Database Preview

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 are two patents 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:2
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
Paragraph IV (Patent) Challenges for 022264
Tradename Dosage Ingredient NDA Submissiondate
INVEGA SUSTENNA SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR paliperidone palmitate 022264 2017-11-21

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
Regulatory Exclusivity Expiration:Dec 20, 2020
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING REGARDING THE COMPARISON OF PALIPERIDONE PALMITATE COMPARED WITH ORAL ANTIPSYCHOTIC TREATMENT IN DELAYING TIME TO TREATMENT FAILURE IN ADULTS WITH SCHIZOPHRENIA WHO HAVE BEEN INCARCERATED
Patent:  Start TrialPatent Expiration:May 10, 2019Product Flag?Substance Flag?Delist Request?
Patent:  Start 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 022264-005 Jul 31, 2009   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-003 Jul 31, 2009   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-001 Jul 31, 2009   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-003 Jul 31, 2009   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-002 Jul 31, 2009   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-005 Jul 31, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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