SODIUM BICARBONATE Drug Patent Profile
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When do Sodium Bicarbonate patents expire, and when can generic versions of Sodium Bicarbonate launch?
Sodium Bicarbonate is a drug marketed by Amneal, Anthea Pharma, Exela Pharma, Fresenius Kabi Usa, Hospira, Intl Medication Sys, Long Grove Pharms, Omnivium Pharms, Steriscience, and Abbott. and is included in fifteen NDAs.
The generic ingredient in SODIUM BICARBONATE is sodium bicarbonate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the sodium bicarbonate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sodium Bicarbonate
A generic version of SODIUM BICARBONATE was approved as sodium bicarbonate by HOSPIRA on March 4th, 2016.
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Questions you can ask:
- What is the 5 year forecast for SODIUM BICARBONATE?
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- What is Average Wholesale Price for SODIUM BICARBONATE?
Summary for SODIUM BICARBONATE
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 15 |
| Finished Product Suppliers / Packagers: | 20 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 300 |
| Patent Applications: | 3,472 |
| Drug Prices: | Drug price information for SODIUM BICARBONATE |
| 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 | Osmotic Activity Alkalinizing 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal | SODIUM BICARBONATE | sodium bicarbonate | SOLUTION;INTRAVENOUS | 217523-001 | Jan 13, 2026 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Long Grove Pharms | SODIUM BICARBONATE | sodium bicarbonate | SOLUTION;INTRAVENOUS | 216042-001 | Feb 27, 2024 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Fresenius Kabi Usa | SODIUM BICARBONATE | sodium bicarbonate | SOLUTION;INTRAVENOUS | 206688-001 | Aug 25, 2025 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Exela Pharma | SODIUM BICARBONATE | sodium bicarbonate | SOLUTION;INTRAVENOUS | 211091-003 | Jun 20, 2019 | AP | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hospira | SODIUM BICARBONATE | sodium bicarbonate | SOLUTION;INTRAVENOUS | 077394-001 | Nov 9, 2005 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Steriscience | SODIUM BICARBONATE | sodium bicarbonate | SOLUTION;INTRAVENOUS | 217594-001 | Jun 28, 2023 | 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 |
