Orange Book product · Brand (NDA)

MOTEGRITY

PRUCALOPRIDE SUCCINATE

Brand (NDA)NDA 210166TE ABRX TAKEDA PHARMS USA

View PRUCALOPRIDE SUCCINATE family Open on FDA Orange Book

At a glance

Dec 14, 2018

Approved

Brand (NDA)

Application

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Dec 14, 2018
7 yr 7 mo ago
Today
Exclusivity ends · M-14
New use / labeling-change exclusivity (3 years)
Jul 10, 2028
in 2 yr 1 mo

Pharmaceutical detail

Active ingredient

PRUCALOPRIDE SUCCINATE

Strength

EQ 1MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 210166

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

View full family

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

Marketing exclusivity (1)

M-14New use / labeling-change exclusivity (3 years)
Jul 10, 2028
in 2 yr 1 mo

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo