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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Argus Health
Covington
Novartis
US Army
Cipla
Farmers Insurance
UBS
Baxter
Dow
Chubb

Generated: December 12, 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 Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Breckenridge Pharm, Dr Reddys Labs Ltd, Glenmark Generics, Impax Labs, Kremers Urban Pharms, Lupin Ltd, Mylan, Sandoz, Teva Pharms Usa, Zydus Pharms Usa Inc, Dexcel Pharma, Gastroentero, Actavis Elizabeth, Ajanta Pharma Ltd, Aurolife Pharma Llc, 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-two suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the omeprazole magnesium profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Dexcel PharmaOMEPRAZOLEomeprazoleTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL209400-001Jul 5, 2017OTCYesNo► Subscribe► Subscribe► Subscribe► Subscribe
SandozOMEPRAZOLEomeprazoleCAPSULE, DELAYED REL PELLETS;ORAL075757-001Jan 28, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdOMEPRAZOLE AND SODIUM BICARBONATEomeprazole; sodium bicarbonateCAPSULE;ORAL204068-001Jul 15, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Par PharmOMEPRAZOLE AND SODIUM BICARBONATEomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL079182-002Apr 19, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Ajanta Pharma LtdOMEPRAZOLE AND SODIUM BICARBONATEomeprazole; sodium bicarbonateCAPSULE;ORAL204228-002Jul 15, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdOMEPRAZOLE AND SODIUM BICARBONATEomeprazole; sodium bicarbonateCAPSULE;ORAL204068-002Jul 15, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sciegen Pharms IncOMEPRAZOLE AND SODIUM BICARBONATEomeprazole; sodium bicarbonateCAPSULE;ORAL207476-001Dec 6, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdOMEPRAZOLE MAGNESIUMomeprazole magnesiumCAPSULE, DELAYED RELEASE;ORAL078878-001Jun 5, 2009OTCNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Lupin LtdOMEPRAZOLEomeprazoleCAPSULE, DELAYED REL PELLETS;ORAL202384-001Aug 25, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
SandozOMEPRAZOLEomeprazoleCAPSULE, DELAYED REL PELLETS;ORAL075757-002Jan 28, 2003ABRXNoYes► Subscribe► 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
Israel130602► Subscribe
Israel147232► Subscribe
Canada2377605► Subscribe
Spain2304349► Subscribe
World Intellectual Property Organization (WIPO)0078284► Subscribe
Germany60038447► Subscribe
Australia5423200► Subscribe
European Patent Office1187599► 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
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
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
C/GB11/013United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 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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Serving leading biopharmaceutical companies globally:

US Department of Justice
QuintilesIMS
Novartis
Johnson and Johnson
Healthtrust
Dow
Cerilliant
Mallinckrodt
Federal Trade Commission
Teva

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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