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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Julphar
Citi
Medtronic
UBS
Cantor Fitzgerald
Healthtrust
Covington
Farmers Insurance

Generated: June 19, 2018

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-six 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 N 50458-560-01
INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264 NDA Janssen Pharmaceuticals, Inc. 50458-561 N 50458-561-01

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:➤ Sign UpPatent Expiration:May 10, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent 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 022264-002 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 022264-004 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
US Army
Merck
McKinsey
Express Scripts
AstraZeneca
UBS
McKesson
Johnson and Johnson

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