You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 25, 2024

Omeprazole; sodium bicarbonate - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

What are the generic sources for omeprazole; sodium bicarbonate and what is the scope of freedom to operate?

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 nineteen NDAs. There are four 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-six suppliers are listed for this compound.

Summary for omeprazole; sodium bicarbonate

International Patents:	5
US Patents:	4
Tradenames:	4
Applicants:	14
NDAs:	19
Finished Product Suppliers / Packagers:	26
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

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009		OTC	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	203290-001	May 25, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sciegen Pharms Inc	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	207476-002	Dec 6, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	204923-001	Nov 7, 2016		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Anda Repository	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	212587-002	Apr 30, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004	⤷ Try a Trial	⤷ Try a Trial
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004	⤷ Try a Trial	⤷ Try a Trial
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009	⤷ Try a Trial	⤷ Try a Trial
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-002	Feb 27, 2006	⤷ Try a Trial	⤷ Try a Trial
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-001	Feb 27, 2006	⤷ Try a Trial	⤷ Try a Trial
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for omeprazole; sodium bicarbonate

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
Mexico	2022000623	COMPOSICIONES Y KITS PARA UNA SUSPENSION DE OMEPRAZOL. (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION.)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2021011669		⤷ Try a Trial
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)	⤷ Try a Trial
European Patent Office	3999066	COMPOSITIONS ET KITS POUR SUSPENSION D'OMÉPRAZOLE (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION)	⤷ Try a Trial
Canada	3147586	COMPOSITIONS ET KITS POUR SUSPENSION D'OMEPRAZOLE (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for omeprazole; sodium bicarbonate

Subscribe to access the full database, or Try a Trial
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	SPC/GB11/013	United Kingdom	⤷ Try a Trial	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900	SPC/GB11/015	United Kingdom	⤷ Try a Trial	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.