Viewing data from:

REGLAN

NDA

METOCLOPRAMIDE HYDROCHLORIDE | N017862 | HIKMA PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

4 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Baxter Healthcare Corporation FDA-2022-P-0115 · 5 docket documents Baxter Healthcare Corporation filed this citizen petition requesting that the FDA determine whether REGLAN (metoclopramide injection, USP), 5 mg/mL, approved under NDA 017862 and held by Hikma Pharmaceuticals USA Inc, was withdrawn from sale for reasons of safety or effectiveness. Baxter believes th	Other	2022-02-03	Granted	Baxter Healthcare Corporation
Corporate Social Responsibility Advocate (Reprieve) - Citizen Petition FDA-2013-P-0990 · 3 docket documents Reprieve, a legal action charity, filed this citizen petition under 21 CFR 10.30 and sections 355, 355-1, 372, and 393 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA suspend approval of Reglan (metoclopramide) manufactured by ANI Pharmaceuticals, Inc. for use in force-feeding de	Other	2013-09-04	Open	—
Citizen Petition from International Medication Systems Limited FDA-1987-P-0413 · 3 docket documents International Medication Systems Limited filed this citizen petition requesting that the FDA determine an abbreviated new drug application is acceptable for Metoclopramide Injection, Reglan®, at a new concentration of 1 mg/mL to replace the currently marketed 5 mg/mL formulation. The petitioner argu	Other	2009-10-22	Denied	International Medication Systems Limited
Citizen Petition from Lachman Consultant Services, Inc. FDA-2004-P-0480 · 3 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA declare metoclopramide hydrochloride orally disintegrating tablets in 5 mg and 10 mg strengths suitable for submission in an ANDA, using the reference listed drug Reglan tablets approved under	Other	2009-10-22	Open	Lachman Consultant Services, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

100 trials from ClinicalTrials.gov — 2 recruiting, 62 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Restoration of Hypoglycemia Awareness With Metoclopramide NCT03970720	Phase 2	Recruiting	Simon Fisher	36	2019-05-28 → 2027-12-31
Efficacy of Metoclopramide in Poor Ovarian Response IVF Patients NCT03560583	N/A	Recruiting	Barzilai Medical Center	60	2021-05-05 → 2028-07
Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis After Receiving Cisplatin NCT01093690	N/A	Completed	Mahidol University	162	2009-04 → 2010-10
Comparison of Metoclopramide and Ibuprofen for the Treatment of Acute Mountain Sickness NCT01522326	N/A	Completed	Massachusetts General Hospital	300	2012-03-01 → 2017-03-30
TRC102 and Temozolomide for Relapsed Solid Tumors and Lymphomas NCT01851369	Phase 1/2	Completed	National Cancer Institute (NCI)	93	2013-07-12 → 2023-08-01
Ondansetron Versus Metoclopramide in Treatment of Vomiting in Gastroenteritis NCT01165866	Phase 4	Completed	Hamad Medical Corporation	170	2008-06 → 2008-12
Maxolon to Improve Breastmilk Supply in Diabetic Women: a Randomised Controlled Trial NCT00477776	Phase 3	Completed	National University Hospital, Singapore	160	2006-04 → 2009-03
Diphenhydramine for Acute Migraine NCT01825941	Phase 4	Completed	Montefiore Medical Center	208	2013-04 → 2014-12
Acupuncture Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean NCT02959840	Phase 4	Completed	Rutgers, The State University of New Jersey	180	2015-07 → 2017-08-23
Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy NCT03435003	Phase 4	Completed	Stony Brook University	83	2017-08-28 → 2019-04-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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

6 letters from Drugs@FDA

Date	Submission	Document
Feb 10, 2026	SUPPL -64	View Letter (PDF)
Nov 22, 2010	SUPPL -63	View Letter (PDF)
Jul 6, 2009	SUPPL -61	View Letter (PDF)
Apr 29, 2004	SUPPL -50	View Letter (PDF)
Apr 29, 2004	SUPPL -51	View Letter (PDF)
Nov 25, 2002	SUPPL -48	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#004 — EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 28, 1987