metoclopramide hydrochloride · Qol Medcl · NDA 209388

Gimoti

Earliest generic entry, as listed
17 Nov 2038

Blocked by patent: US 12377064. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 7 unexpired

PatentClaimsExpires
US 12377064use U-284317 Nov 2038
US 8334281product, use U-284316 May 2030
US 11020361use U-284322 Dec 2029
US 11628150product, use U-284322 Dec 2029
US 11813231product, use U-284322 Dec 2029
US 12194008use U-284322 Dec 2029
US 12194009use U-284322 Dec 2029

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 1

NDA · productFormStrengthListed expiry
209388 · 001 · RLDspray, metered, nasalEQ 15MG BASE/SPRAY17 Nov 2038