Orange Book product · Brand (NDA)

QUILLIVANT XR

METHYLPHENIDATE HYDROCHLORIDE

Brand (NDA)NDA 202100TE ABRX NEXTWAVE

Sep 27, 2012

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 27, 2012
13 yr 11 mo ago
Today
Patent 8062667 expires
Listed drug product patent expiration.
Mar 29, 2029
in 2 yr 10 mo
Patent 8287903 expires
Listed drug product patent expiration.
Feb 15, 2031
in 4 yr 9 mo
Patent 8465765 expires
Listed drug product patent expiration.
Feb 15, 2031
in 4 yr 9 mo
Patent 8563033 expires
Listed drug product patent expiration.
Feb 15, 2031
in 4 yr 9 mo
Patent 8778390 expires
Listed drug product patent expiration.
Feb 15, 2031
in 4 yr 9 mo
Patent 8956649 expires
Listed drug product patent expiration.
Feb 15, 2031
in 4 yr 9 mo
Patent 9040083 expires
Listed drug product patent expiration.
Feb 15, 2031
in 4 yr 9 mo

Active ingredient

METHYLPHENIDATE HYDROCHLORIDE

Strength

5MG/ML

Dosage form

FOR SUSPENSION, EXTENDED RELEASE

Route

ORAL

TE code

Application

NDA 202100

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
8062667	Mar 29, 2029	in 2 yr 10 mo	Product
8287903	Feb 15, 2031	in 4 yr 9 mo	Product
8465765	Feb 15, 2031	in 4 yr 9 mo	ProductU-1415
8563033	Feb 15, 2031	in 4 yr 9 mo	ProductU-1415
8778390	Feb 15, 2031	in 4 yr 9 mo	ProductU-1543
8956649	Feb 15, 2031	in 4 yr 9 mo	ProductU-1665
9040083	Feb 15, 2031	in 4 yr 9 mo	Product