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Metoclopramide hydrochloride - Generic Drug Details

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Metoclopramide hydrochloride is the generic ingredient in nine branded drugs marketed by Teva, Ani Pharms, Wockhardt, Hospira, King Pharms, Halsey, Ipca Labs Ltd, Watson Labs, Interpharm, Sandoz, Robins Ah, Smith And Nephew, Superpharm, Quantum Pharmics, Teva Pharms Usa, Sun Pharm Inds, Roxane, Clonmel, Usl Pharma, Actavis Mid Atlantic, Par Pharm, Bedford, Pharm Assoc, Salix Pharms, Morton Grove, Impax Labs Inc, Vistapharm, Emcure Pharms Ltd, Mutual Pharm, West-ward Pharms Int, Paco, Northstar Hlthcare, Vintage Pharms, Silarx, Par Pharm Inc, Novel Labs Inc, Fresenius Kabi Usa, Norbrook, Lyphomed, Meda Pharms, and Schering, and is included in sixty-five NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has seventeen patent family members in nine countries.

There are twelve drug master file entries for metoclopramide hydrochloride. Fifty-three suppliers are listed for this compound.

Summary for Generic Name: metoclopramide hydrochloride

Tradenames:9
Patents:3
Applicants:41
NDAs:65
Drug Master File Entries: see list12
Suppliers / Packaging: see list53
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: metoclopramide hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Superpharm
METOCLOPRAMIDE HYDROCHLORIDE
metoclopramide hydrochloride
TABLET;ORAL070926-001Jun 26, 1987DISCNNo► subscribe► subscribe
Salix Pharms
METOZOLV ODT
metoclopramide hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL022246-002Sep 4, 2009DISCNNo6,413,549► subscribeY ► subscribe
Norbrook
METOCLOPRAMIDE HYDROCHLORIDE
metoclopramide hydrochloride
INJECTABLE;INJECTION070892-001Aug 26, 1988DISCNNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: metoclopramide hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
West-ward Pharms Int
REGLAN
metoclopramide hydrochloride
INJECTABLE;INJECTION017862-004May 28, 19874,536,386► subscribe
West-ward Pharms Int
REGLAN
metoclopramide hydrochloride
INJECTABLE;INJECTION017862-001Approved Prior to Jan 1, 19824,536,386► subscribe
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Non-Orange Book Patents for Generic Ingredient: metoclopramide hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,976,577 Process for preparing fast dispersing solid oral dosage form► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: metoclopramide hydrochloride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9846215► subscribe
Japan2012162558► subscribe
Australia6896998► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.

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