SODIUM BICARBONATE - Generic Drug Details

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

Sodium bicarbonate is the generic ingredient in three branded drugs marketed by Exela Pharma, Hospira, Intl Medication Sys, Long Grove Pharms, Omnivium Pharms, Steriscience, Abbott, and Mallinckrodt Inc, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-four drug master file entries for sodium bicarbonate. Sixteen suppliers are listed for this compound.

Sponsor	Phase
Indiana University	Phase 4
Taipei Medical University Shuang Ho Hospital	Phase 2
University of Southern California	Phase 2

Sponsor

Phase

Indiana University

Phase 4

Taipei Medical University Shuang Ho Hospital

Phase 2

University of Southern California

Phase 2

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Long Grove Pharms	SODIUM BICARBONATE	sodium bicarbonate	INJECTABLE;INJECTION	216042-001	Feb 27, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Omnivium Pharms	SODIUM BICARBONATE	sodium bicarbonate	INJECTABLE;INJECTION	216364-001	Jun 15, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	SODIUM BICARBONATE	sodium bicarbonate	INJECTABLE;INJECTION	202494-001	Mar 6, 2017	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbott	SODIUM BICARBONATE IN PLASTIC CONTAINER	sodium bicarbonate	INJECTABLE;INJECTION	019443-002	Jun 3, 1986		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Exela Pharma	SODIUM BICARBONATE	sodium bicarbonate	INJECTABLE;INJECTION	211091-001	Jun 20, 2019	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Steriscience	SODIUM BICARBONATE	sodium bicarbonate	INJECTABLE;INJECTION	217594-001	Jun 28, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	3
Applicants:	8
NDAs:	13
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	168
Clinical Trials:	264
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

Drug Class	Osmotic Laxative
Mechanism of Action	Alkalinizing Activity Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption