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Last Updated: March 29, 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, Morton Grove, Paco, Pharm Assoc, 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-seven suppliers are listed for this compound.

Recent Clinical Trials for METOCLOPRAMIDE HYDROCHLORIDE

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

SponsorPhase
Genuine Research Center, EgyptPhase 3
Adwia Pharma, EgyptPhase 3
Sohag UniversityPhase 2/Phase 3

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 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 074147-001 Aug 2, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Robins Ah REGLAN metoclopramide hydrochloride SOLUTION;ORAL 018821-001 Mar 25, 1983 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride INJECTABLE;INJECTION 073135-001 Nov 27, 1991 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pharm Assoc METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride SOLUTION;ORAL 072744-001 May 28, 1991 AA RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 021793-002 Jun 10, 2005 ⤷  Try a Trial ⤷  Try a Trial
Hikma REGLAN metoclopramide hydrochloride INJECTABLE;INJECTION 017862-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Meda Pharms REGLAN ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793-001 Jun 10, 2005 ⤷  Try a Trial ⤷  Try a Trial
Meda Pharms REGLAN ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793-001 Jun 10, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for METOCLOPRAMIDE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Poland 2376075 ⤷  Try a Trial
Canada 2780485 FORMULATIONS NASALES DE METOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE) ⤷  Try a Trial
Canada 3224872 FORMULATIONS NASALES DE METOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE) ⤷  Try a Trial
Denmark 2376075 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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