Sodium bicarbonate - Generic Drug Details
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What are the generic drug sources for sodium bicarbonate and what is the scope of patent protection?
Sodium bicarbonate
is the generic ingredient in three branded drugs marketed by Amneal, Anthea Pharma, Aspiro, Exela Pharma, Fresenius Kabi Usa, Hospira, Intl Medication Sys, Long Grove Pharms, Omnivium Pharms, Steriscience, Abbott, and Mallinckrodt Inc, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-four drug master file entries for sodium bicarbonate. Twenty-one suppliers are listed for this compound.
Summary for sodium bicarbonate
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 12 |
| NDAs: | 17 |
| Drug Master File Entries: | 24 |
| Finished Product Suppliers / Packagers: | 21 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 300 |
| Patent Applications: | 6,588 |
| Drug Prices: | Drug price trends for sodium bicarbonate |
| What excipients (inactive ingredients) are in sodium bicarbonate? | sodium bicarbonate excipients list |
| DailyMed Link: | sodium bicarbonate at DailyMed |
Recent Clinical Trials for sodium bicarbonate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Nextrast, Inc. | PHASE1 |
| University of Copenhagen | NA |
| Copenhagen Trial Unit, Center for Clinical Intervention Research | NA |
Pharmacology for sodium bicarbonate
| Drug Class | Osmotic Laxative |
| Mechanism of Action | Alkalinizing Activity Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Anatomical Therapeutic Chemical (ATC) Classes for sodium bicarbonate
US Patents and Regulatory Information for sodium bicarbonate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Exela Pharma | SODIUM BICARBONATE | sodium bicarbonate | SOLUTION;INTRAVENOUS | 211091-003 | Jun 20, 2019 | AP | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Fresenius Kabi Usa | SODIUM BICARBONATE | sodium bicarbonate | SOLUTION;INTRAVENOUS | 206688-002 | Aug 25, 2025 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hospira | SODIUM BICARBONATE | sodium bicarbonate | SOLUTION;INTRAVENOUS | 202494-002 | Mar 6, 2017 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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