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Serving leading biopharmaceutical companies globally:

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Harvard Business School
Healthtrust
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Generated: October 16, 2017

DrugPatentWatch Database Preview

Omeprazole - Generic Drug Details

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What are the generic drug sources for omeprazole and what is the scope of omeprazole patent protection?

Omeprazole
is the generic ingredient in seven branded drugs marketed by Dexcel Pharma, Kremers Urban Pharms, Astrazeneca 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, Perrigo R And D, Covis Pharma Bv, Aurolife Pharma Llc, Ajanta Pharma Ltd, Santarus Inc, Actavis Elizabeth, Par Pharm, Sciegen Pharms Inc, and Bayer Healthcare Llc, and is included in thirty-seven NDAs. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Omeprazole has thirty-four patent family members in seventeen countries and five supplementary protection certificates in two countries.

There are one hundred and twenty-four drug master file entries for omeprazole. One hundred and twelve suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: omeprazole

US Patents:14
Tradenames:7
Applicants:24
NDAs:37
Drug Master File Entries: see list124
Suppliers / Packagers: see list112
Bulk Api Vendors: see list106
Clinical Trials: see list278
Patent Applications: see list6,110
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:omeprazole at DailyMed

Pharmacology for Ingredient: omeprazole

Tentative approvals for OMEPRAZOLE

Applicant Application No. Strength Dosage Form
u► Subscribe10MGCAPSULE, DELAYED REL PELLETS;ORAL
u► Subscribe40MGCAPSULE, DELAYED REL PELLETS;ORAL
u► Subscribe20MGCAPSULE, DELAYED REL PELLETS;ORAL
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► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004ABRXYesNo► Subscribe► SubscribeYY ► Subscribe
Ajanta Pharma Ltd
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL204228-001Jul 15, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004ABRXYesNo► Subscribe► SubscribeYY ► Subscribe
Sandoz
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL075757-001Jan 28, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL075576-001Jan 21, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-001Feb 27, 2006ABRXYesNo► Subscribe► Subscribe ► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004ABRXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-002Jan 15, 1998DISCNYesNo► Subscribe► SubscribeY► Subscribe
Zydus Pharms Usa Inc
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL091352-003Nov 19, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: omeprazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-003Oct 5, 1995► Subscribe► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-002Jan 15, 1998► Subscribe► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-003Oct 5, 1995► Subscribe► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 1989► Subscribe► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-002Jan 15, 1998► Subscribe► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-002Jan 15, 1998► Subscribe► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-003Oct 5, 1995► Subscribe► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-002Jan 15, 1998► Subscribe► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-002Jan 15, 1998► Subscribe► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 1989► Subscribe► 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
Austria360626► Subscribe
Australia5470999► Subscribe
South Africa200101140► Subscribe
Norway20010677► Subscribe
Portugal1104417► Subscribe
Austria390119► Subscribe
Germany69935915► Subscribe
Canada2393366► Subscribe
Spain2304349► Subscribe
European Patent Office1104417► 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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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Deloitte
Teva
Chubb
Baxter
Citi
Dow
Harvard Business School
Boehringer Ingelheim
Farmers Insurance

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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