Orange Book product · Brand (NDA)

ZYPITAMAG

PITAVASTATIN MAGNESIUM

Brand (NDA)NDA 208379DISCN MEDICURE

Jul 14, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 14, 2017
9 yr 1 mo ago
Today
Patent 8829186 expires
Listed drug substance patent expiration.
Jan 19, 2031
in 4 yr 8 mo

Active ingredient

PITAVASTATIN MAGNESIUM

Strength

EQ 1MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 208379

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
8829186	Jan 19, 2031	in 4 yr 8 mo	SubstanceProduct