Orange Book product · Brand (NDA)

INVEGA SUSTENNA

PALIPERIDONE PALMITATE

Brand (NDA)NDA 022264RX JANSSEN PHARMS

Jul 31, 2009

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 31, 2009
17 yr 2 mo ago
Today
Patent 9439906 expires
Listed method-of-use patent (U-2758) expiration.
Jan 26, 2031
in 4 yr 8 mo
Patent 9439906 expires
Listed method-of-use patent (U-2757) expiration.
Jan 26, 2031
in 4 yr 8 mo

Active ingredient

PALIPERIDONE PALMITATE

Strength

39MG/0.25ML (39MG/0.25ML)

Dosage form

SUSPENSION, EXTENDED RELEASE

Route

INTRAMUSCULAR

TE code

Not listed

Application

NDA 022264

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9439906	Jan 26, 2031	in 4 yr 8 mo	U-2758
9439906	Jan 26, 2031	in 4 yr 8 mo	U-2757