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 patent protection?

Omeprazole; sodium bicarbonate is the generic ingredient in four branded drugs marketed by Ajanta Pharma Ltd, Anda Repository, Aurobindo Pharma, Aurolife Pharma Llc, Chartwell Rx, Dr Reddys, Perrigo R And D, Sciegen Pharms Inc, Strides Pharma, Zydus, Zydus Pharms, Salix, Riley Consumer, and Azurity, and is included in twenty NDAs. There are six patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Omeprazole; sodium bicarbonate has five patent family members in five countries.

Twenty-eight suppliers are listed for this compound.

Summary for omeprazole; sodium bicarbonate

International Patents:	5
US Patents:	6
Tradenames:	4
Applicants:	14
NDAs:	20
Finished Product Suppliers / Packagers:	28
Clinical Trials:	12
DailyMed Link:	omeprazole; sodium bicarbonate at DailyMed

Recent Clinical Trials for omeprazole; sodium bicarbonate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Food and Drug Administration (FDA)	Phase 1
BioPharma Services, Inc	Phase 1
Ajou University School of Medicine	Phase 1

See all omeprazole; sodium bicarbonate clinical trials

Pharmacology for omeprazole; sodium bicarbonate

Drug Class	Proton Pump Inhibitor Osmotic Laxative
Mechanism of Action	Alkalinizing Activity Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Anatomical Therapeutic Chemical (ATC) Classes for omeprazole; sodium bicarbonate

Paragraph IV (Patent) Challenges for OMEPRAZOLE; SODIUM BICARBONATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZEGERID OTC	Capsules	omeprazole; sodium bicarbonate	20 mg/1100 mg	022281	1	2010-04-20
ZEGERID	Powder for Oral Suspension	omeprazole; sodium bicarbonate	20mg/1680mg per packet	021636	1	2007-11-13
ZEGERID	Powder for Oral Suspension	omeprazole; sodium bicarbonate	40 mg/1680 mg per packet	021636	1	2007-08-24
ZEGERID	Capsules	omeprazole; sodium bicarbonate	20 mg/1100 mg and 40 mg/1100 mg	021849	1	2007-04-30

US Patents and Regulatory Information for omeprazole; sodium bicarbonate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	204068-002	Jul 15, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	204068-001	Jul 15, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurolife Pharma Llc	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	204922-001	Aug 19, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	204137-001	Jul 15, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ajanta Pharma Ltd	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	204228-002	Jul 15, 2016	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	203290-002	May 25, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for omeprazole; sodium bicarbonate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-001	Jun 15, 2004	⤷ Sign Up	⤷ Sign Up
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-001	Jun 15, 2004	⤷ Sign Up	⤷ Sign Up
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009	⤷ Sign Up	⤷ Sign Up
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-001	Feb 27, 2006	⤷ Sign Up	⤷ Sign Up
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004	⤷ Sign Up	⤷ Sign Up
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for omeprazole; sodium bicarbonate

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2021011669		⤷ Sign Up
China	114761002	用于奥美拉唑混悬剂的组合物和试剂盒 (Compositions and kits for omeprazole suspensions)	⤷ Sign Up
European Patent Office	3999066	COMPOSITIONS ET KITS POUR SUSPENSION D'OMÉPRAZOLE (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION)	⤷ Sign Up
Canada	3147586	COMPOSITIONS ET KITS POUR SUSPENSION D'OMEPRAZOLE (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION)	⤷ Sign Up
Mexico	2022000623	COMPOSICIONES Y KITS PARA UNA SUSPENSION DE OMEPRAZOL. (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION.)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for omeprazole; sodium bicarbonate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	SPC/GB11/013	United Kingdom	⤷ Sign Up	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900	SPC/GB11/015	United Kingdom	⤷ Sign Up	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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