Details for New Drug Application (NDA): 022264

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. Three 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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022264

Constraining patent/regulatory exclusivity:

5,254,556

Dosage:

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 022264

Medical Subject Heading (MeSH) Categories for 022264

Antipsychotic Agents

Dopamine D2 Receptor Antagonists

Serotonin 5-HT2 Receptor Antagonists

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:		RLD:	Yes
Patent:	9,439,906	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:	9,439,906	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)

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR			Strength	78MG/0.5ML (78MG/0.5ML)
Approval Date:	Jul 31, 2009	TE:		RLD:	Yes
Patent:	9,439,906	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)

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	6,077,843*PED
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-003	Jul 31, 2009	5,254,556*PED
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-005	Jul 31, 2009	6,077,843*PED
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-005	Jul 31, 2009	6,555,544*PED

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