Orange Book product · Brand (NDA)

CLEVIPREX

CLEVIDIPINE

Brand (NDA)NDA 022156DISCN CHIESI

Nov 08, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 08, 2013
12 yr 10 mo ago
Today
Patent 10010537 expires
Listed drug product patent expiration.
Oct 10, 2031
in 5 yr 5 mo
Patent 11103490 expires
Listed drug product patent expiration.
Oct 10, 2031
in 5 yr 5 mo
Patent 8658676 expires
Listed drug product patent expiration.
Oct 10, 2031
in 5 yr 5 mo

Active ingredient

CLEVIDIPINE

Strength

125MG/250ML (0.5MG/ML)

Dosage form

EMULSION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 022156

Product number

003

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
10010537	Oct 10, 2031	in 5 yr 5 mo	Product
11103490	Oct 10, 2031	in 5 yr 5 mo	Product
8658676	Oct 10, 2031	in 5 yr 5 mo	Product