Viewing data from:

GIMOTI

NDA

METOCLOPRAMIDE HYDROCHLORIDE | N209388 | QOL MEDICAL LLC

1 strength7 unique patents0 unique exclusivities

Patent Timeline

7 unique patents by expiration date

Active (7)Today

2026

2027

2028

2029

2030

2031

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2039

Today

May. 16, 2030

Dec. 22, 2029

Dec. 22, 2029

Dec. 22, 2029

Dec. 22, 2029

Dec. 22, 2029

Nov. 17, 2038

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
EVOKE PHARMA, INC. v. TEVA PHARMACEUTICALS INC. et al 1:2022cv02019 2 patentsANDA 216931metoclopramide	D.N.J.	2022-04-07	Terminated 2023-01-30	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Gimoti (2023)

Total Spending

$2.9M

Total Claims

1,457

Beneficiaries

489

Avg Cost/Unit

$206.35

Spending Trend

$374K(2021)→$1.4M(2022)→$2.9M(2023)

YoY Change:+13.2%

5yr CAGR:+6.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs5 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

COSMA SPAMETOCLOPRAMIDE HYDROCHLORIDE

DMF 45231982

LIAOYUAN SILVER EAGLE PHARMACEUTICAL CO LTDMETOCLOPRAMIDE HYDROCHLORIDE

DMF 289872014

EMCURE PHARMACEUTICALS LTDMETOCLOPRAMIDE HYDROCHLORIDE USP

DMF 329912018

DINAMITE DIPHARMA SPAInactiveMETOCLOPRAMIDE HYDROCHLORIDE BP'80

DMF 43811981

ORGAMOL SAInactiveMETOCLOPRAMIDE

DMF 58131985

BOEHRINGER INGELHEIM CHEMICALS INCInactiveMETOCLOPRAMIDE

DMF 60701985

MEDICHEM SAInactiveMETOCLOPRAMIDE HYDROCHLORIDE

DMF 62391986

BENZOCHEM LIFESCIENCES PVT LTDInactiveMETOCLOPRAMIDE HYDROCHLORIDE USP

DMF 212712008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Feb 10, 2026	SUPPL -4	View Letter (PDF)
Jan 19, 2021	SUPPL -1	View Letter (PDF)
Jun 23, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 15MG BASE/SPRAY

RLD

7 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Jun 19, 2020

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
8334281	May 16, 2030	—	—	Yes	—
11020361	Dec 22, 2029	—	—	—	—
11628150	Dec 22, 2029	—	—	Yes	—
11813231	Dec 22, 2029	—	—	Yes	—
12194008	Dec 22, 2029	—	—	—	—
12194009	Dec 22, 2029	—	—	—	—
12377064	Nov 17, 2038	—	—	—	—