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Last Updated: August 15, 2020

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METOCLOPRAMIDE HYDROCHLORIDE - Generic Drug Details

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What are the generic 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, 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, Evoke Pharma Inc, 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-five NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Metoclopramide hydrochloride has nineteen patent family members in twelve countries.

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

Recent Clinical Trials for METOCLOPRAMIDE HYDROCHLORIDE

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

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
Novel Labs Inc METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 202191-001 Aug 15, 2014 RX No No   Start Trial   Start Trial   Start Trial
Wockhardt Bio Ag METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride SOLUTION;ORAL 074703-001 Oct 31, 1997 AA RX No Yes   Start Trial   Start Trial   Start Trial
Quantum Pharmics CLOPRA-YELLOW metoclopramide hydrochloride TABLET;ORAL 070632-001 Oct 28, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 070511-001 Jan 22, 1986 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
Yaopharma Co Ltd METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 074478-001 Oct 5, 1995 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 022246-001 Sep 4, 2009   Start Trial   Start Trial
Meda Pharms REGLAN ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793-002 Jun 10, 2005   Start Trial   Start Trial
West-ward Pharms Int REGLAN metoclopramide hydrochloride INJECTABLE;INJECTION 017862-004 May 28, 1987   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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