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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 nine branded drugs marketed by Roxane, Emcure Pharms Ltd, Bedford, Fresenius Kabi Usa, Hospira, Lyphomed, Norbrook, Smith And Nephew, Teva Pharms Usa, West-ward Pharms Int, Actavis Mid Atlantic, Ani Pharms, Lannett Co Inc, Morton Grove, Paco, Pharm Assoc, Teva, Vistapharm, Wockhardt Bio Ag, Robins Ah, Novel Labs Inc, Salix Pharms, Meda Pharms, Quantum Pharmics, King Pharms, Clonmel, Halsey, Impax Labs Inc, Interpharm, Ipca Labs Ltd, Mutual Pharm, Northstar Hlthcare, Par Pharm, Par Pharm Inc, Sandoz, Schering, Sun Pharm Industries, Superpharm, Usl Pharma, Vintage Pharms, Watson Labs, and Yaopharma Co Ltd, and is included in sixty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for metoclopramide hydrochloride. Thirty-two suppliers are listed for this compound.

Summary for metoclopramide hydrochloride

US Patents:	0
Tradenames:	9
Applicants:	42
NDAs:	64
Drug Master File Entries:	14
Suppliers / Packagers:	32
Bulk Api Vendors:	62
Clinical Trials:	203
Patent Applications:	106
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for metoclopramide hydrochloride
DailyMed Link:	metoclopramide hydrochloride at DailyMed

Recent Clinical Trials for metoclopramide hydrochloride

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

Sponsor	Phase
Rajesh Deshar	N/A
Assiut University	Early Phase 1
Anthony Seto	Phase 1/Phase 2

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

Paragraph IV (Patent) Challenges for METOCLOPRAMIDE HYDROCHLORIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
METOZOLV ODT	TABLET, ORALLY DISINTEGRATING;ORAL	metoclopramide hydrochloride	022246	2010-08-24
REGLAN	INJECTABLE;INJECTION	metoclopramide hydrochloride	017862

US Patents and Regulatory Information for metoclopramide hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	REGLAN	metoclopramide hydrochloride	TABLET;ORAL	017854-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Clonmel	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET;ORAL	072639-001	May 9, 1991		DISCN	No	No
Hospira	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	INJECTABLE;INJECTION	074147-001	Aug 2, 1996		DISCN	No	No
Smith And Nephew	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	INJECTABLE;INJECTION	070622-001	Mar 2, 1987		DISCN	No	No
Actavis Mid Atlantic	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	SOLUTION;ORAL	071340-001	Aug 18, 1988		DISCN	No	No
Lannett Co Inc	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	SOLUTION;ORAL	073680-001	Oct 27, 1992		DISCN	No	No

Expired US Patents for metoclopramide hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-001	Jun 10, 2005
West-ward Pharms Int	REGLAN	metoclopramide hydrochloride	INJECTABLE;INJECTION	017862-001	Approved Prior to Jan 1, 1982
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-002	Jun 10, 2005
Salix Pharms	METOZOLV ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022246-002	Sep 4, 2009
Salix Pharms	METOZOLV ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022246-001	Sep 4, 2009
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-001	Jun 10, 2005