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Last Updated: July 21, 2024

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.

Recent Clinical Trials for metoclopramide hydrochloride

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

SponsorPhase
Health Sciences North Research InstituteN/A
Wollo UniversityPhase 4
Genuine Research Center, EgyptPhase 3

See all metoclopramide hydrochloride clinical trials

Pharmacology for metoclopramide hydrochloride
Medical Subject Heading (MeSH) Categories for metoclopramide hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for metoclopramide hydrochloride
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride INJECTABLE;INJECTION 070506-001 Jun 22, 1989 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
King Pharms MAXOLON metoclopramide hydrochloride TABLET;ORAL 070106-001 Mar 4, 1986 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Meda Pharms REGLAN ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793-002 Jun 10, 2005 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

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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