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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Boehringer Ingelheim
Daiichi Sankyo
Covington
Medtronic
Cerilliant
Harvard Business School
Colorcon
Queensland Health
US Department of Justice

Generated: December 11, 2017

DrugPatentWatch Database Preview

Metoclopramide hydrochloride - Generic Drug Details

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What are the generic drug sources for metoclopramide hydrochloride and what is the scope of metoclopramide hydrochloride patent protection?

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

Metoclopramide hydrochloride has twenty patent family members in nine countries.

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

Pharmacology for metoclopramide hydrochloride

Medical Subject Heading (MeSH) Categories for metoclopramide hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
West-ward Pharms IntREGLANmetoclopramide hydrochlorideINJECTABLE;INJECTION017862-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Novel Labs IncMETOCLOPRAMIDE HYDROCHLORIDEmetoclopramide hydrochlorideTABLET, ORALLY DISINTEGRATING;ORAL202191-002Aug 15, 2014RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Usl PharmaMETOCLOPRAMIDE HYDROCHLORIDEmetoclopramide hydrochlorideTABLET;ORAL070339-001Jul 29, 1985DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
TevaMETOCLOPRAMIDE HYDROCHLORIDEmetoclopramide hydrochlorideSOLUTION;ORAL071315-001Jun 30, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Impax Labs IncMETOCLOPRAMIDE HYDROCHLORIDEmetoclopramide hydrochlorideTABLET;ORAL071250-001Feb 3, 1988ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Watson LabsMETOCLOPRAMIDE HYDROCHLORIDEmetoclopramide hydrochlorideTABLET;ORAL070511-001Jan 22, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Smith And NephewMETOCLOPRAMIDE HYDROCHLORIDEmetoclopramide hydrochlorideINJECTABLE;INJECTION070623-001Mar 2, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Pharm AssocMETOCLOPRAMIDE HYDROCHLORIDEmetoclopramide hydrochlorideSOLUTION;ORAL072744-001May 28, 1991AARXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
RoxaneMETOCLOPRAMIDE INTENSOLmetoclopramide hydrochlorideCONCENTRATE;ORAL072995-001Jan 30, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
InterpharmMETOCLOPRAMIDE HYDROCHLORIDEmetoclopramide hydrochlorideTABLET;ORAL071213-001Sep 24, 1986DISCNNoNo► Subscribe► Subscribe► 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 IntREGLANmetoclopramide hydrochlorideINJECTABLE;INJECTION017862-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Salix PharmsMETOZOLV ODTmetoclopramide hydrochlorideTABLET, ORALLY DISINTEGRATING;ORAL022246-002Sep 4, 2009► Subscribe► Subscribe
Salix PharmsMETOZOLV ODTmetoclopramide hydrochlorideTABLET, ORALLY DISINTEGRATING;ORAL022246-001Sep 4, 2009► Subscribe► Subscribe
West-ward Pharms IntREGLANmetoclopramide hydrochlorideINJECTABLE;INJECTION017862-004May 28, 1987► Subscribe► 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
Japan5072513► Subscribe
Japan2001524956► Subscribe
Australia6896998► Subscribe
Japan4943581► Subscribe
Japan2008001726► Subscribe
Spain2525720► Subscribe
Japan2012162558► Subscribe
European Patent Office0975336► Subscribe
Hong Kong1137654► Subscribe
European Patent Office2266538► 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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Serving leading biopharmaceutical companies globally:

Queensland Health
Chinese Patent Office
Fuji
Cerilliant
Chubb
Johnson and Johnson
AstraZeneca
QuintilesIMS
Boehringer Ingelheim
Deloitte

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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