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Generated: December 14, 2017

DrugPatentWatch Database Preview

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 Actavis Elizabeth, Ajanta Pharma Ltd, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Par Pharm, Perrigo R And D, Sciegen Pharms Inc, Santarus 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 omeprazole; sodium bicarbonate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Perrigo R And DOMEPRAZOLE AND SODIUM BICARBONATEomeprazole; sodium bicarbonateCAPSULE;ORAL201361-001Jul 15, 2016OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Bayer Healthcare LlcZEGERID OTComeprazole; sodium bicarbonateCAPSULE;ORAL022281-001Dec 1, 2009OTCYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL021636-002Dec 21, 2004ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Sciegen Pharms IncOMEPRAZOLE AND SODIUM BICARBONATEomeprazole; sodium bicarbonateCAPSULE;ORAL207476-001Dec 6, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL021636-002Dec 21, 2004ABRXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Bayer Healthcare LlcZEGERID OTComeprazole; sodium bicarbonateCAPSULE;ORAL022281-001Dec 1, 2009OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Bayer Healthcare LlcZEGERID OTComeprazole; sodium bicarbonateFOR SUSPENSION;ORAL022283-001Jun 17, 2013OTCYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Ajanta Pharma LtdOMEPRAZOLE AND SODIUM BICARBONATEomeprazole; sodium bicarbonateCAPSULE;ORAL204228-002Jul 15, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Aurolife Pharma LlcOMEPRAZOLE AND SODIUM BICARBONATEomeprazole; sodium bicarbonateCAPSULE;ORAL204922-001Aug 19, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL021636-001Jun 15, 2004ABRXYesNo► Subscribe► 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 LlcZEGERID OTComeprazole; sodium bicarbonateFOR SUSPENSION;ORAL022283-001Jun 17, 2013► Subscribe► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateCAPSULE;ORAL021849-002Feb 27, 2006► Subscribe► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL021636-001Jun 15, 2004► Subscribe► Subscribe
Bayer Healthcare LlcZEGERID OTComeprazole; sodium bicarbonateCAPSULE;ORAL022281-001Dec 1, 2009► Subscribe► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL021636-001Jun 15, 2004► Subscribe► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL021636-001Jun 15, 2004► Subscribe► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateCAPSULE;ORAL021849-001Feb 27, 2006► Subscribe► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL021636-002Dec 21, 2004► Subscribe► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateCAPSULE;ORAL021849-002Feb 27, 2006► Subscribe► Subscribe
Bayer Healthcare LlcZEGERID OTComeprazole; sodium bicarbonateFOR SUSPENSION;ORAL022283-001Jun 17, 2013► Subscribe► Subscribe
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International Patent Family for Ingredient: omeprazole; sodium bicarbonate

Country Document Number Estimated Expiration
Brazil0107565► Subscribe
MexicoPA04006912► Subscribe
Australia2005229686► Subscribe
Russian Federation2002121623► Subscribe
Canada2453117► Subscribe
Norway20043442► Subscribe
Poland201906► Subscribe
Australia3276701► Subscribe
European Patent Office1538908► Subscribe
World Intellectual Property Organization (WIPO)03009846► 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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Serving leading biopharmaceutical companies globally:

Deloitte
Julphar
Boehringer Ingelheim
Citi
Chubb
Cantor Fitzgerald
Mallinckrodt
Teva
Cerilliant
Novartis

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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