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Serving 500+ biopharmaceutical companies globally:

Cipla
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Generated: June 24, 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 Kremers Urban Pharms, Sandoz, Dexcel Pharma, Actavis Labs Fl Inc, Apotex, Zydus Pharms Usa Inc, Teva Pharms Usa, Aurobindo Pharma Ltd, Glenmark Generics, Dr Reddys Labs Ltd, Mylan, 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 twenty-nine NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has nine patent family members in eight countries.

The generic ingredient in OMEPRAZOLE is omeprazole magnesium. There are one hundred and twenty-one drug master file entries for this compound. Twenty 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

Patents:1
Applicants:20
NDAs:29
Suppliers / Packagers: see list105
Bulk Api Vendors: see list106
Clinical Trials: see list268
Patent Applications: see list5,667
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
Aurolife Pharma Llc
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL204923-001Nov 7, 2016OTCNoNo► Subscribe► Subscribe
Impax Labs
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL075785-001Oct 22, 2007ABRXNoNo► Subscribe► Subscribe
Par Pharm
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL078966-001May 25, 2010ABRXNoNo► Subscribe► Subscribe
Ajanta Pharma Ltd
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL205545-001Jul 27, 2016ABRXNoNo► Subscribe► Subscribe
Par Pharm
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL078966-002May 25, 2010ABRXNoNo► Subscribe► Subscribe
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Paragraph IV activity 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
Israel147232► Subscribe
Austria390119► Subscribe
Israel130602► Subscribe
Canada2377605► Subscribe
Germany60038447► 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
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
C/GB01/006United Kingdom► SubscribePRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Cerilliant
Baxter
Argus Health
Merck
Express Scripts
QuintilesIMS
Citi
Moodys
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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