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-seven 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: | 27 |
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 |
---|---|
BioPharma Services, Inc | Phase 1 |
Food and Drug Administration (FDA) | Phase 1 |
Ajou University School of Medicine | Phase 1 |
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
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 | 201946-001 | Jul 15, 2016 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Strides Pharma | OMEPRAZOLE AND SODIUM BICARBONATE | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 078966-001 | May 25, 2010 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Anda Repository | OMEPRAZOLE AND SODIUM BICARBONATE | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 212587-002 | Apr 30, 2020 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Salix | ZEGERID | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 021849-002 | Feb 27, 2006 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Sciegen Pharms Inc | OMEPRAZOLE AND SODIUM BICARBONATE | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 207476-002 | Dec 6, 2016 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
>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
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 | ⤷ Subscribe | ⤷ Subscribe |
Riley Consumer | ZEGERID OTC | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 022281-001 | Dec 1, 2009 | ⤷ Subscribe | ⤷ Subscribe |
Salix | ZEGERID | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 021636-001 | Jun 15, 2004 | ⤷ Subscribe | ⤷ Subscribe |
Salix | ZEGERID | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 021636-002 | Dec 21, 2004 | ⤷ Subscribe | ⤷ Subscribe |
Salix | ZEGERID | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 021636-002 | Dec 21, 2004 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OMEPRAZOLE; SODIUM BICARBONATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 2022000623 | ⤷ Subscribe | |
Canada | 3147586 | ⤷ Subscribe | |
Canada | 3147586 | COMPOSITIONS ET KITS POUR SUSPENSION D'OMEPRAZOLE (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION) | ⤷ Subscribe |
European Patent Office | 3999066 | COMPOSITIONS ET KITS POUR SUSPENSION D'OMÉPRAZOLE (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION) | ⤷ Subscribe |
European Patent Office | 3999066 | ⤷ Subscribe | |
>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 | ⤷ Subscribe | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
0984957 | SPC/GB11/013 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
OMEPRAZOLE; SODIUM BICARBONATE Market Analysis and Financial Projection Experimental
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