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Omeprazole - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for omeprazole?

Omeprazole is the generic ingredient in seven branded drugs marketed by Kremers Urban Pharms, Astrazeneca Pharms, Sandoz, Dexcel Pharma, Actavis Labs Fl Inc, Apotex, Zydus Pharms Usa Inc, Aurobindo Pharma Ltd, Glenmark Generics, Dr Reddys Labs Ltd, Mylan, Lupin Ltd, Impax Labs, Perrigo R And D, Aurolife Pharma Llc, Ajanta Pharma Ltd, Santarus Inc, Actavis Elizabeth, Par Pharm, Sciegen Pharms Inc, and Bayer Healthcare Llc, and is included in thirty-four NDAs. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-two patent family members in seventeen countries.

There are one hundred and twenty drug master file entries for omeprazole. One hundred and four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: omeprazole

Tradenames:7
Patents:15
Applicants:21
NDAs:34
Drug Master File Entries: see list120
Suppliers / Packagers: see list104
Bulk Api Vendors: see list106
Clinical Trials: see list100
Patent Applications: see list5,667
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:omeprazole at DailyMed

Pharmacology for Ingredient: omeprazole

Tentative approvals for OMEPRAZOLE

Applicant Application No. Form Dosage
► Subscribe► SubscribeCAPSULE, DELAYED REL PELLETS; ORAL10MG
► Subscribe► SubscribeCAPSULE, DELAYED REL PELLETS; ORAL20MG
► Subscribe► SubscribeTABLET, DELAYED RELEASE;ORAL20MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Healthcare Llc
ZEGERID OTC
omeprazole; sodium bicarbonate
CAPSULE;ORAL022281-001Dec 1, 2009OTCYesYes6,699,885► SubscribeYY ► Subscribe
Actavis Labs Fl Inc
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL075347-002May 30, 2008RXNoNo► Subscribe► Subscribe
Dr Reddys Labs Ltd
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL075576-001Jan 21, 2009RXNoNo► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004RXYesNo7,399,772► Subscribe ► Subscribe
Actavis Elizabeth
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL204137-001Jul 15, 2016OTCNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: omeprazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 19894,853,230*PED► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 19894,636,499*PED► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 19895,093,342*PED► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-002Jan 15, 19984,255,431*PED► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-003Oct 5, 19955,599,794*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: omeprazole

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
7,255,878Stable benzimidazole formulation► 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: omeprazole

Country Document Number Estimated Expiration
Australia5423200► Subscribe
Hong Kong1034510► Subscribe
Israel147232► Subscribe
Germany60038447► Subscribe
Spain2285857► 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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Supplementary Protection Certificates for Tradename: OMEPRAZOLE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/013United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
C/GB11/015United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
C/GB01/006United Kingdom► SubscribePRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
12/048Ireland► SubscribePRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
11/016Ireland► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
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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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