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Generated: December 18, 2017

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 three 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-four 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:1
Applicant:1
Ingredient:1
Patents:3
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

Summary 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:Nov 12, 2017
Regulatory Exclusivity Use:SCHIZOAFFECTIVE DISORDER AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS
Patent:► SubscribePatent Expiration:Nov 12, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:May 10, 2019Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 022264

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen PharmsINVEGA SUSTENNApaliperidone palmitateSUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-004Jul 31, 2009► Subscribe► Subscribe
Janssen PharmsINVEGA SUSTENNApaliperidone palmitateSUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-002Jul 31, 2009► Subscribe► Subscribe
Janssen PharmsINVEGA SUSTENNApaliperidone palmitateSUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-003Jul 31, 2009► Subscribe► Subscribe
Janssen PharmsINVEGA SUSTENNApaliperidone palmitateSUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-004Jul 31, 2009► Subscribe► Subscribe
Janssen PharmsINVEGA SUSTENNApaliperidone palmitateSUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-005Jul 31, 2009► Subscribe► Subscribe
Janssen PharmsINVEGA SUSTENNApaliperidone palmitateSUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-001Jul 31, 2009► Subscribe► Subscribe
Janssen PharmsINVEGA SUSTENNApaliperidone palmitateSUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-003Jul 31, 2009► Subscribe► Subscribe
Janssen PharmsINVEGA SUSTENNApaliperidone palmitateSUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-002Jul 31, 2009► Subscribe► Subscribe
Janssen PharmsINVEGA SUSTENNApaliperidone palmitateSUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-003Jul 31, 2009► Subscribe► Subscribe
Janssen PharmsINVEGA SUSTENNApaliperidone palmitateSUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-004Jul 31, 2009► Subscribe► Subscribe
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