Orange Book product · Brand (NDA)

ASPRUZYO SPRINKLE

RANOLAZINE

Brand (NDA)NDA 216018DISCN SPIL

Feb 28, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 28, 2022
4 yr 4 mo ago
Today
Patent 10898444 expires
Listed drug product patent expiration.
Jan 24, 2038
in 11 yr 9 mo
Patent 11510878 expires
Listed drug product patent expiration.
Jan 24, 2038
in 11 yr 9 mo
Patent 12161761 expires
Listed drug product patent expiration.
Jan 24, 2038
in 11 yr 9 mo

Active ingredient

RANOLAZINE

Strength

1GM

Dosage form

GRANULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 216018

Product number

002

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
10898444	Jan 24, 2038	in 11 yr 9 mo	Product
11510878	Jan 24, 2038	in 11 yr 9 mo	Product
12161761	Jan 24, 2038	in 11 yr 9 mo	Product