Orange Book product · Brand (NDA)

RYKINDO

RISPERIDONE

Brand (NDA)NDA 212849DISCN SHANDONG LUYE

Jan 13, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 13, 2023
3 yr 6 mo ago
Today
Patent 10098882 expires
Listed drug product patent expiration.
Apr 10, 2032
in 5 yr 11 mo
Patent 10406161 expires
Listed drug product patent expiration.
Apr 10, 2032
in 5 yr 11 mo
Patent 11110094 expires
Listed drug product patent expiration.
Apr 10, 2032
in 5 yr 11 mo
Patent 9446135 expires
Listed drug product patent expiration.
Apr 10, 2032
in 5 yr 11 mo
Patent 9532991 expires
Listed drug product patent expiration.
Apr 10, 2032
in 5 yr 11 mo

Active ingredient

RISPERIDONE

Strength

12.5MG

Dosage form

FOR SUSPENSION, EXTENDED RELEASE

Route

INTRAMUSCULAR

TE code

Not listed

Application

NDA 212849

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
10098882	Apr 10, 2032	in 5 yr 11 mo	ProductU-3513
10406161	Apr 10, 2032	in 5 yr 11 mo	ProductU-3513
11110094	Apr 10, 2032	in 5 yr 11 mo	Product
9446135	Apr 10, 2032	in 5 yr 11 mo	ProductU-3513
9532991	Apr 10, 2032	in 5 yr 11 mo	ProductU-3513