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Omeprazole - Generic Drug Details

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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 Usa, 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, and Bayer Healthcare Llc, and is included in thirty-three NDAs. There are sixteen 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 eighteen drug master file entries for omeprazole. One hundred and one suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: omeprazole

Tradenames:7
Patents:16
Applicants:20
NDAs:33
Drug Master File Entries: see list118
Suppliers / Packaging: see list101
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: omeprazole

Tentative approvals for OMEPRAZOLE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE, DELAYED REL PELLETS; ORAL10MG
<disabled><disabled>CAPSULE, DELAYED REL PELLETS; ORAL20MG
<disabled><disabled>TABLET, DELAYED RELEASE;ORAL20MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms
PRILOSEC
omeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022056-001Mar 20, 2008RXNo5,900,424► subscribeY ► subscribe
Dr Reddys Labs Ltd
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL075576-003Oct 22, 2007RXNo► subscribe► subscribe
Par Pharm
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL079182-002Apr 19, 2013DISCNNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: omeprazole

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-003Oct 5, 19954,853,230*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;ORAL019810-003Oct 5, 19955,093,342*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
Germany69935915► subscribe
Japan2003516985► subscribe
Israel130602► 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
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
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
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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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