Metoclopramide hydrochloride - Generic Drug Details

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What are the generic drug sources for metoclopramide hydrochloride and what is the scope of freedom to operate?

Metoclopramide hydrochloride is the generic ingredient in ten branded drugs marketed by Roxane, Avet Lifesciences, Bedford, Fresenius Kabi Usa, Hospira, Lyphomed, Norbrook, Smith And Nephew, Teva Pharms Usa, Hikma, Actavis Mid Atlantic, Ani Pharms, Chartwell Molecular, Genus, Morton Grove, Paco, Pharmobedient Cnsltg, Teva, Vistapharm, Robins Ah, Evoke Pharma Inc, Novel Labs Inc, Salix Pharms, Meda Pharms, Quantum Pharmics, King Pharms, Aiping Pharm Inc, Chartwell Rx, Clonmel, Halsey, Impax Labs Inc, Interpharm, Ipca Labs Ltd, Mutual Pharm, Northstar Hlthcare, Par Pharm, Sandoz, Schering, Strides Pharma, Sun Pharm Industries, Superpharm, Usl Pharma, and Watson Labs, and is included in sixty-five NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Metoclopramide hydrochloride has ten patent family members in seven countries.

There are six drug master file entries for metoclopramide hydrochloride. Twenty-nine suppliers are listed for this compound.

Summary for metoclopramide hydrochloride

International Patents:	10
US Patents:	4
Tradenames:	10
Applicants:	43
NDAs:	65
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	263
Patent Applications:	182
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for metoclopramide hydrochloride
What excipients (inactive ingredients) are in metoclopramide hydrochloride?	metoclopramide hydrochloride excipients list
DailyMed Link:	metoclopramide hydrochloride at DailyMed

Recent Clinical Trials for metoclopramide hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Health Sciences North Research Institute	N/A
Wollo University	Phase 4
Adwia Pharma, Egypt	Phase 3

See all metoclopramide hydrochloride clinical trials

Pharmacology for metoclopramide hydrochloride

Drug Class	Dopamine-2 Receptor Antagonist
Mechanism of Action	Dopamine D2 Antagonists

Medical Subject Heading (MeSH) Categories for metoclopramide hydrochloride

Antiemetics
Dopamine D2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for metoclopramide hydrochloride

A03FA	Propulsives
A03F	PROPULSIVES
A03	DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for METOCLOPRAMIDE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GIMOTI	Metered Nasal Spray	metoclopramide hydrochloride	15 mg/spray	209388	1	2021-12-30
METOZOLV ODT	Orally Disintegrating Tablets	metoclopramide hydrochloride	5 mg and 10 mg	022246	1	2010-08-24

US Patents and Regulatory Information for metoclopramide hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Halsey	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET;ORAL	070906-001	Oct 28, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Avet Lifesciences	METOCLOPRAMIDE	metoclopramide hydrochloride	INJECTABLE;INJECTION	204756-001	Dec 20, 2013	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Robins Ah	REGLAN	metoclopramide hydrochloride	SOLUTION;ORAL	018821-001	Mar 25, 1983		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET;ORAL	070453-001	Jun 6, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vistapharm	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	SOLUTION;ORAL	075051-001	Jan 26, 2001		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Northstar Hlthcare	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET;ORAL	078374-002	Nov 30, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for metoclopramide hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-002	Jun 10, 2005	⤷ Sign Up	⤷ Sign Up
Hikma	REGLAN	metoclopramide hydrochloride	INJECTABLE;INJECTION	017862-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Salix Pharms	METOZOLV ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022246-001	Sep 4, 2009	⤷ Sign Up	⤷ Sign Up
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-002	Jun 10, 2005	⤷ Sign Up	⤷ Sign Up
Evoke Pharma Inc	GIMOTI	metoclopramide hydrochloride	SPRAY, METERED;NASAL	209388-001	Jun 19, 2020	⤷ Sign Up	⤷ Sign Up
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-001	Jun 10, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for metoclopramide hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Canada	3224872	FORMULATIONS NASALES DE METOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE)	⤷ Sign Up
Canada	3155873	FORMULATIONS NASALES DE METOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE)	⤷ Sign Up
Canada	2780485	FORMULATIONS NASALES DE METOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE)	⤷ Sign Up
Portugal	2376075		⤷ Sign Up
Poland	2376075		⤷ Sign Up
European Patent Office	2376075	FORMULATIONS NASALES DE MÉTOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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