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Serving 500+ biopharmaceutical companies globally:

Cipla
Accenture
Moodys
Citi
Teva
Fuji
US Department of Justice
US Army
Colorcon
McKesson

Generated: August 21, 2017

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Omeprazole; sodium bicarbonate - Generic Drug Details

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

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.

Omeprazole; sodium bicarbonate has sixty-two patent family members in twenty-four countries.

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

Summary for Generic Name: omeprazole; sodium bicarbonate

Tradenames:3
Patents:7
Applicants:9
NDAs:15
Drug Master File Entries: see list121
Suppliers / Packagers: see list20
Clinical Trials: see list2,687
Drug Prices:see low prices
DailyMed Link:omeprazole; sodium bicarbonate at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004ABRXYesNo► Subscribe► Subscribe ► Subscribe
Dr Reddys Labs Ltd
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL204068-002Jul 15, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Par Pharm
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL079182-002Apr 19, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-002Feb 27, 2006ABRXYesYes► Subscribe► Subscribe ► Subscribe
Sciegen Pharms Inc
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL207476-002Dec 6, 2016ABRXNoNo► Subscribe► 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
Bayer Healthcare Llc
ZEGERID OTC
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL022283-001Jun 17, 2013► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-001Feb 27, 2006► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004► Subscribe► Subscribe
Bayer Healthcare Llc
ZEGERID OTC
omeprazole; sodium bicarbonate
CAPSULE;ORAL022281-001Dec 1, 2009► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004► Subscribe► Subscribe
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International Patent Family for Ingredient: omeprazole; sodium bicarbonate

Country Document Number Estimated Expiration
Norway20023313► Subscribe
Japan4991432► Subscribe
Brazil0107565► Subscribe
MexicoPA04000223► Subscribe
European Patent Office1927354► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Healthtrust
Teva
Dow
McKesson
Julphar
Cerilliant
Cantor Fitzgerald
Fish and Richardson
Johnson and Johnson

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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