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Serving leading biopharmaceutical companies globally:

Healthtrust
Teva
Daiichi Sankyo
Queensland Health
Merck
Cipla
Farmers Insurance
Cerilliant
Covington
Fish and Richardson

Generated: October 21, 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 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-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 nineteen patent family members in nine countries.

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

Summary for Generic Name: metoclopramide hydrochloride

US Patents:3
Tradenames:9
Applicants:41
NDAs:64
Drug Master File Entries: see list12
Suppliers / Packagers: see list47
Bulk Api Vendors: see list44
Clinical Trials: see list2,425
Patent Applications: see list98
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:metoclopramide hydrochloride at DailyMed

Pharmacology for Ingredient: metoclopramide hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wockhardt
METOCLOPRAMIDE HYDROCHLORIDE
metoclopramide hydrochloride
SOLUTION;ORAL074703-001Oct 31, 1997AARXNoYes► Subscribe► Subscribe► Subscribe
Ani Pharms
REGLAN
metoclopramide hydrochloride
TABLET;ORAL017854-002May 5, 1987ABRXYesNo► Subscribe► Subscribe► Subscribe
Ani Pharms
METOCLOPRAMIDE HYDROCHLORIDE
metoclopramide hydrochloride
SOLUTION;ORAL071402-001Jun 25, 1993AARXNoNo► Subscribe► Subscribe► Subscribe
Meda Pharms
REGLAN ODT
metoclopramide hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021793-001Jun 10, 2005DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Silarx
METOCLOPRAMIDE HYDROCHLORIDE
metoclopramide hydrochloride
SOLUTION;ORAL073680-001Oct 27, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds
METOCLOPRAMIDE HYDROCHLORIDE
metoclopramide hydrochloride
TABLET;ORAL071536-001Apr 28, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe
Robins Ah
REGLAN
metoclopramide hydrochloride
SOLUTION;ORAL018821-001Mar 25, 1983DISCNYesNo► Subscribe► Subscribe► Subscribe
Morton Grove
METOCLOPRAMIDE HYDROCHLORIDE
metoclopramide hydrochloride
SOLUTION;ORAL070949-001Mar 6, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Norbrook
METOCLOPRAMIDE HYDROCHLORIDE
metoclopramide hydrochloride
INJECTABLE;INJECTION070892-001Aug 26, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
Hospira
METOCLOPRAMIDE HYDROCHLORIDE
metoclopramide hydrochloride
INJECTABLE;INJECTION070847-001Nov 7, 1988DISCNNoNo► 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
Salix Pharms
METOZOLV ODT
metoclopramide hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL022246-001Sep 4, 2009► Subscribe► Subscribe
West-ward Pharms Int
REGLAN
metoclopramide hydrochloride
INJECTABLE;INJECTION017862-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
West-ward Pharms Int
REGLAN
metoclopramide hydrochloride
INJECTABLE;INJECTION017862-004May 28, 1987► Subscribe► Subscribe
Salix Pharms
METOZOLV ODT
metoclopramide hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL022246-002Sep 4, 2009► 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
Japan2008001726► Subscribe
World Intellectual Property Organization (WIPO)9902140► Subscribe
Japan5072513► Subscribe
Australia726336► Subscribe
European Patent Office2266538► Subscribe
Portugal2147669► Subscribe
Japan4943581► Subscribe
Japan2012162558► Subscribe
World Intellectual Property Organization (WIPO)9846215► Subscribe
Japan2001524956► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
Johnson and Johnson
Medtronic
Chubb
Covington
Express Scripts
Cerilliant
Deloitte
Fuji

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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