Orange Book product · Brand (NDA)

GIMOTI

METOCLOPRAMIDE HYDROCHLORIDE

Brand (NDA)NDA 209388RX QOL MEDCL

Jun 19, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 19, 2020
6 yr 1 mo ago
Today
Patent 11020361 expires
Listed method-of-use patent (U-2843) expiration.
Dec 22, 2029
in 3 yr 7 mo
Patent 11628150 expires
Listed drug product patent expiration.
Dec 22, 2029
in 3 yr 7 mo
Patent 11813231 expires
Listed drug product patent expiration.
Dec 22, 2029
in 3 yr 7 mo
Patent 12194008 expires
Listed method-of-use patent (U-2843) expiration.
Dec 22, 2029
in 3 yr 7 mo
Patent 12194009 expires
Listed method-of-use patent (U-2843) expiration.
Dec 22, 2029
in 3 yr 7 mo
Patent 8334281 expires
Listed drug product patent expiration.
May 16, 2030
in 4 yr
Patent 12377064 expires
Listed method-of-use patent (U-2843) expiration.
Nov 17, 2038
in 12 yr 7 mo

Active ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Strength

EQ 15MG BASE/SPRAY

Dosage form

SPRAY, METERED

Route

NASAL

TE code

Not listed

Application

NDA 209388

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
11020361	Dec 22, 2029	in 3 yr 7 mo	U-2843
11628150	Dec 22, 2029	in 3 yr 7 mo	ProductU-2843
11813231	Dec 22, 2029	in 3 yr 7 mo	ProductU-2843
12194008	Dec 22, 2029	in 3 yr 7 mo	U-2843
12194009	Dec 22, 2029	in 3 yr 7 mo	U-2843
8334281	May 16, 2030	in 4 yr	ProductU-2843
12377064	Nov 17, 2038	in 12 yr 7 mo	U-2843