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Generated: April 30, 2017

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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 Kremers Urban Pharms, Astrazeneca Pharms, Sandoz, Dexcel Pharma, Actavis Labs Fl Inc, Apotex, Zydus Pharms Usa Inc, Aurobindo Pharma Ltd, Glenmark Generics, Dr Reddys Labs Ltd, Mylan, Lupin Ltd, Impax Labs, Perrigo R And D, Aurolife Pharma Llc, Ajanta Pharma Ltd, Santarus Inc, Actavis Elizabeth, Par Pharm, Sciegen Pharms Inc, and Bayer Healthcare Llc, and is included in thirty-four NDAs. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Omeprazole has thirty-two patent family members in seventeen countries.

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

Summary for Generic Name: omeprazole

Tradenames:7
Patents:15
Applicants:21
NDAs:34
Drug Master File Entries: see list121
Suppliers / Packagers: see list105
Bulk Api Vendors: see list106
Clinical Trials: see list100
Patent Applications: see list5,711
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. Form Dosage
► Subscribe► SubscribeCAPSULE, DELAYED REL PELLETS; ORAL10MG
► Subscribe► SubscribeCAPSULE, DELAYED REL PELLETS; ORAL20MG
► Subscribe► SubscribeTABLET, DELAYED RELEASE;ORAL20MG
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms
PRILOSEC
omeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022056-001Mar 20, 2008RXYesNo6,428,810► SubscribeY ► Subscribe
Bayer Healthcare Llc
ZEGERID OTC
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL022283-001Jun 17, 2013OTCYesYes7,399,772► Subscribe ► Subscribe
Aurolife Pharma Llc
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL204923-001Nov 7, 2016OTCNoNo► Subscribe► Subscribe
Apotex
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL076048-003Jan 21, 2009ABRXNoNo► Subscribe► Subscribe
Apotex
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL076048-002Oct 22, 2007ABRXNoNo► Subscribe► Subscribe
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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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