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Last Updated: March 29, 2024

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 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-five 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: 25
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

SponsorPhase
Food and Drug Administration (FDA)Phase 1
BioPharma Services, IncPhase 1
CTC Bio, Inc.Phase 1

See all omeprazole; sodium bicarbonate clinical trials

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Strides Pharma OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 078966-001 May 25, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Riley Consumer ZEGERID OTC omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 022283-001 Jun 17, 2013 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 203290-002 May 25, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ajanta Pharma Ltd OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 205545-001 Jul 27, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Perrigo R And D OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 201361-001 Jul 15, 2016 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204068-001 Jul 15, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Azurity KONVOMEP omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 213593-001 Aug 30, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

International Patents for omeprazole; sodium bicarbonate

Country Patent Number Title Estimated Expiration
Canada 3147586 COMPOSITIONS ET KITS POUR SUSPENSION D'OMEPRAZOLE (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
Mexico 2022000623 COMPOSICIONES Y KITS PARA UNA SUSPENSION DE OMEPRAZOL. (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION.) ⤷  Try a Trial
European Patent Office 3999066 COMPOSITIONS ET KITS POUR SUSPENSION D'OMÉPRAZOLE (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for omeprazole; sodium bicarbonate

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

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