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Last Updated: October 4, 2024

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, 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. Thirty-two suppliers are listed for this compound.

Summary for METOCLOPRAMIDE HYDROCHLORIDE
Recent Clinical Trials for METOCLOPRAMIDE HYDROCHLORIDE

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

SponsorPhase
Health Sciences North Research InstituteN/A
Wollo UniversityPhase 4
Adwia Pharma, 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
Bedford METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride INJECTABLE;INJECTION 072155-001 Mar 30, 1992 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Quantum Pharmics CLOPRA metoclopramide hydrochloride TABLET;ORAL 070294-001 Jul 29, 1985 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 070184-001 Jul 29, 1985 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Molecular METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride SOLUTION;ORAL 073680-001 Oct 27, 1992 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 021793-001 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
Meda Pharms REGLAN ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793-001 Jun 10, 2005 ⤷  Sign Up ⤷  Sign Up
Meda Pharms REGLAN ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793-002 Jun 10, 2005 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for METOCLOPRAMIDE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Canada 2984736 FORMULATIONS NASALES DE METOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE) ⤷  Sign Up
European Patent Office 2376075 FORMULATIONS NASALES DE MÉTOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2010075444 ⤷  Sign Up
Denmark 2376075 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.