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OMEPRAZOLE Drug Profile

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Omeprazole is a drug marketed by Kremers Urban 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, Gastroentero, Aurolife Pharma Llc, Ajanta Pharma Ltd, Actavis Elizabeth, Par Pharm, and Perrigo R And D. and is included in twenty-seven NDAs. It is available from one hundred suppliers. 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 eighteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the omeprazole magnesium profile page.

Summary for Tradename: OMEPRAZOLE

Patents:1
Applicants:18
NDAs:27
Suppliers / Packagers: see list100
Drug Prices: :see details

Pharmacology for Tradename: OMEPRAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ajanta Pharma Ltd
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL204228-002Jul 15, 2016RXNo► subscribe► subscribe
Impax Labs
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL075785-003Jan 21, 2009RXNo► subscribe► subscribe
Dr Reddys Labs Ltd
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL204068-001Jul 15, 2016RXNo► 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
Spain2304349► subscribe
Israel130602► subscribe
Australia5423200► 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
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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