Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Moodys
Harvard Business School
Boehringer Ingelheim
McKinsey
Mallinckrodt
McKesson

Last Updated: August 11, 2022

Metoclopramide hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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, Emcure Pharms Ltd, 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, Teva, Vistapharm, Wockhardt Bio Ag, Robins Ah, Evoke Pharma Inc, Novel Labs Inc, Salix Pharms, Meda Pharms, Quantum Pharmics, King Pharms, 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 two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Metoclopramide hydrochloride has nine patent family members in seven countries.

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

Recent Clinical Trials for metoclopramide hydrochloride

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

SponsorPhase
Tanta UniversityPhase 2
Instituto Mexicano del Seguro SocialPhase 4
Cairo UniversityN/A

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 072247-001 May 18, 1992 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sandoz METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 070850-001 Feb 3, 1987 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Impax Labs Inc METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 071250-002 Dec 28, 1995 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Roxane METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride SOLUTION;ORAL 072038-001 Dec 5, 1988 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Interpharm METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 071213-001 Sep 24, 1986 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 070453-001 Jun 6, 1986 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 070184-001 Jul 29, 1985 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Salix Pharms METOZOLV ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 022246-001 Sep 4, 2009 See Plans and Pricing See Plans and Pricing
Hikma REGLAN metoclopramide hydrochloride INJECTABLE;INJECTION 017862-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Evoke Pharma Inc GIMOTI metoclopramide hydrochloride SPRAY, METERED;NASAL 209388-001 Jun 19, 2020 See Plans and Pricing See Plans and Pricing
Meda Pharms REGLAN ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793-002 Jun 10, 2005 See Plans and Pricing See Plans and Pricing
Meda Pharms REGLAN ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793-002 Jun 10, 2005 See Plans and Pricing See Plans and Pricing
Salix Pharms METOZOLV ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 022246-002 Sep 4, 2009 See Plans and Pricing See Plans and Pricing
Hikma REGLAN metoclopramide hydrochloride INJECTABLE;INJECTION 017862-004 May 28, 1987 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for metoclopramide hydrochloride

Country Patent Number Title Estimated Expiration
Denmark 2376075 See Plans and Pricing
Poland 2376075 See Plans and Pricing
Canada 2984736 FORMULATIONS NASALES DE METOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE) See Plans and Pricing
Portugal 2376075 See Plans and Pricing
European Patent Office 2376075 FORMULATIONS NASALES DE MÉTOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2010075444 See Plans and Pricing
Canada 2780485 FORMULATIONS NASALES DE METOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Johnson and Johnson
Merck
McKinsey
Moodys
Boehringer Ingelheim

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.