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Last Updated: July 7, 2020

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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.

Recent Clinical Trials for metoclopramide hydrochloride

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SponsorPhase
Rajesh DesharN/A
Assiut UniversityEarly Phase 1
Anthony SetoPhase 1/Phase 2

See all metoclopramide hydrochloride clinical trials

Pharmacology for metoclopramide hydrochloride
Medical Subject Heading (MeSH) Categories for metoclopramide hydrochloride
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   Start Trial   Start Trial   Start Trial
Clonmel METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 072639-001 May 9, 1991 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride INJECTABLE;INJECTION 074147-001 Aug 2, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Smith And Nephew METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride INJECTABLE;INJECTION 070622-001 Mar 2, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Actavis Mid Atlantic METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride SOLUTION;ORAL 071340-001 Aug 18, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Lannett Co Inc METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride SOLUTION;ORAL 073680-001 Oct 27, 1992 DISCN No No   Start Trial   Start Trial   Start Trial
>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

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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Johnson and Johnson
Merck
McKinsey
Moodys
Boehringer Ingelheim

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