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Last Updated: July 7, 2020

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METOCLOPRAMIDE HYDROCHLORIDE Drug Profile


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When do Metoclopramide Hydrochloride patents expire, and what generic alternatives are available?

Metoclopramide Hydrochloride is a drug marketed by Bedford, Fresenius Kabi Usa, Hospira, Lyphomed, Norbrook, Smith And Nephew, Teva Pharms Usa, Actavis Mid Atlantic, Ani Pharms, Lannett Co Inc, Morton Grove, Paco, Pharm Assoc, Roxane, Teva, Vistapharm, Wockhardt Bio Ag, Novel Labs Inc, 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 fifty-three NDAs.

The generic ingredient in METOCLOPRAMIDE HYDROCHLORIDE is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Metoclopramide Hydrochloride

A generic version of METOCLOPRAMIDE HYDROCHLORIDE was approved as metoclopramide hydrochloride by TEVA on July 29th, 1985.

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Drug patent expirations by year for METOCLOPRAMIDE HYDROCHLORIDE
Recent Clinical Trials for METOCLOPRAMIDE HYDROCHLORIDE

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

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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
Par Pharm METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 070342-001 Mar 25, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Halsey METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 070906-001 Oct 28, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Teva METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 072801-001 Jun 15, 1993 AB RX 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

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Serving leading biopharmaceutical companies globally:

Dow
Colorcon
Harvard Business School
Mallinckrodt
Johnson and Johnson
McKesson

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