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Serving leading biopharmaceutical companies globally:

Fuji
Healthtrust
Express Scripts
Cipla
QuintilesIMS
Chinese Patent Office
Medtronic
Colorcon
Cantor Fitzgerald
US Army

Generated: October 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-four patent family members in twenty-four countries and two supplementary protection certificates in one country.

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

Summary for Generic Name: omeprazole; sodium bicarbonate

US Patents:7
Tradenames:3
Applicants:9
NDAs:15
Drug Master File Entries: see list124
Suppliers / Packagers: see list22
Clinical Trials: see list2,723
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
Aurolife Pharma Llc
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL204923-001Nov 7, 2016OTCNoNo► Subscribe► Subscribe► Subscribe
Bayer Healthcare Llc
ZEGERID OTC
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL022283-001Jun 17, 2013OTCYesYes► Subscribe► Subscribe ► Subscribe
Aurolife Pharma Llc
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL204922-002Aug 19, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Actavis Elizabeth
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL204137-001Jul 15, 2016OTCNoNo► Subscribe► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Bayer Healthcare Llc
ZEGERID OTC
omeprazole; sodium bicarbonate
CAPSULE;ORAL022281-001Dec 1, 2009OTCYesYes► Subscribe► SubscribeYY ► Subscribe
Sciegen Pharms Inc
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL207476-001Dec 6, 2016ABRXNoNo► 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;ORAL021636-001Jun 15, 2004ABRXYesNo► Subscribe► Subscribe ► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004ABRXYesYes► Subscribe► SubscribeYY ► 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;ORAL021636-002Dec 21, 2004► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-002Feb 27, 2006► Subscribe► Subscribe
Bayer Healthcare Llc
ZEGERID OTC
omeprazole; sodium bicarbonate
CAPSULE;ORAL022281-001Dec 1, 2009► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-002Feb 27, 2006► Subscribe► Subscribe
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;ORAL021636-001Jun 15, 2004► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-002Feb 27, 2006► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004► Subscribe► Subscribe
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International Patent Family for Ingredient: omeprazole; sodium bicarbonate

Country Document Number Estimated Expiration
Japan4991432► Subscribe
Australia2002330863► Subscribe
Australia2003214858► Subscribe
Japan2005519901► Subscribe
Brazil0306965► Subscribe
Australia782488► Subscribe
Australia1907100► Subscribe
Russian Federation2002121623► Subscribe
MexicoPA04000223► Subscribe
Japan2007277271► 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/GB11/013United 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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Novartis
Argus Health
US Army
US Department of Justice
QuintilesIMS
Deloitte
Dow
Farmers Insurance
Daiichi Sankyo
Queensland Health

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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