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Serving leading biopharmaceutical companies globally:

US Army
Cipla
Deloitte
Teva
Johnson and Johnson
Moodys
Mallinckrodt
Colorcon
Harvard Business School
McKinsey

Generated: October 16, 2017

DrugPatentWatch Database Preview

OMEPRAZOLE Drug Profile

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Which patents cover Omeprazole, and when can generic versions of Omeprazole launch?

Omeprazole is a drug marketed by Dexcel Pharma, Kremers Urban Pharms, Sandoz, Actavis Labs Fl Inc, Apotex, Zydus Pharms Usa Inc, Teva Pharms Usa, Aurobindo Pharma Ltd, Glenmark Generics, Dr Reddys Labs Ltd, Mylan, Breckenridge Pharm, Lupin Ltd, Impax Labs, Gastroentero, Aurolife Pharma Llc, Ajanta Pharma Ltd, Actavis Elizabeth, Par Pharm, Perrigo R And D, and Sciegen Pharms Inc. and is included in thirty-one NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has nine patent family members in eight countries and five supplementary protection certificates in two countries.

The generic ingredient in OMEPRAZOLE is omeprazole magnesium. There are one hundred and twenty-four drug master file entries for this compound. Twenty-one suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the omeprazole magnesium profile page.

Summary for Tradename: OMEPRAZOLE

US Patents:1
Applicants:21
NDAs:31
Suppliers / Packagers: see list111
Bulk Api Vendors: see list106
Clinical Trials: see list278
Patent Applications: see list5,199
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:OMEPRAZOLE at DailyMed

Pharmacology for Tradename: OMEPRAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL078490-001Apr 17, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Breckenridge Pharm
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL203481-001Jul 3, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Ajanta Pharma Ltd
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL205545-001Jul 27, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Par Pharm
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL079182-002Apr 19, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurolife Pharma Llc
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL204923-001Nov 7, 2016OTCNoNo► Subscribe► Subscribe► Subscribe
Ajanta Pharma Ltd
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL205545-002Jul 27, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL204068-001Jul 15, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Perrigo R And D
OMEPRAZOLE MAGNESIUM
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL204152-001Jul 30, 2015OTCNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL075576-001Jan 21, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Breckenridge Pharm
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL203481-002Jul 3, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for OMEPRAZOLE

Drugname Dosage Strength RLD Submissiondate
omeprazoleDelayed-release Tablets20 mgOmeprazole6/3/2015

Non-Orange Book Patents for Tradename: 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 Tradename: OMEPRAZOLE

Country Document Number Estimated Expiration
Spain2304349► Subscribe
European Patent Office1187599► Subscribe
World Intellectual Property Organization (WIPO)0078284► Subscribe
Germany60038447► Subscribe
Australia5423200► Subscribe
Israel147232► Subscribe
Canada2377605► Subscribe
Israel130602► Subscribe
Austria390119► 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/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
C/GB11/015United 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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Deloitte
Moodys
Cantor Fitzgerald
Fish and Richardson
Federal Trade Commission
Fuji
Mallinckrodt
Citi
McKinsey
US Department of Justice

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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