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Omeprazole; sodium bicarbonate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for omeprazole; sodium bicarbonate?

Omeprazole; sodium bicarbonate is the generic ingredient in three branded drugs marketed by Aurolife Pharma Llc, Ajanta Pharma Ltd, Santarus Inc, Actavis Elizabeth, Par Pharm, Perrigo R And D, Dr Reddys Labs Ltd, Sciegen Pharms Inc, and Bayer Healthcare Llc, and is included in fifteen NDAs. There are seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty patent family members in twenty-three countries.

There are one hundred and twenty drug master file entries for omeprazole; sodium bicarbonate. Fourteen suppliers are listed for this compound.

Summary for Generic Name: omeprazole; sodium bicarbonate

Tradenames:3
Patents:8
Applicants:9
NDAs:15
Drug Master File Entries: see list120
Suppliers / Packagers: see list14
Clinical Trials: see list1,037
Drug Prices:see low prices
DailyMed Link:omeprazole; sodium bicarbonate at DailyMed

Pharmacology for Ingredient: omeprazole; sodium bicarbonate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004RXYesNo7,399,772► Subscribe ► Subscribe
Bayer Healthcare Llc
ZEGERID OTC
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL022283-001Jun 17, 2013OTCYesYes6,780,882► SubscribeY ► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004RXYesYes5,840,737► Subscribe ► Subscribe
Perrigo R And D
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL201361-001Jul 15, 2016OTCNoNo► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-001Feb 27, 2006RXYesNo7,399,772► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: omeprazole; sodium bicarbonate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004RE45198► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 20046,780,882► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-001Feb 27, 20066,489,346► Subscribe
Bayer Healthcare Llc
ZEGERID OTC
omeprazole; sodium bicarbonate
CAPSULE;ORAL022281-001Dec 1, 20097,399,772► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 20046,645,988► Subscribe
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International Patent Family for Ingredient: omeprazole; sodium bicarbonate

Country Document Number Estimated Expiration
Canada2453117► Subscribe
Poland367272► Subscribe
Taiwan200303220► Subscribe
Japan2012136531► Subscribe
Australia2005229686► 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; SODIUM BICARBONATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/015United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
C/GB11/013United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 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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