Calcium gluconate - Generic Drug Details

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

Calcium gluconate is the generic ingredient in two branded drugs marketed by Amneal, B Braun Medical Inc, Fresenius Kabi Usa, Nivagen Pharms Inc, Somerset, and Hq Spclt Pharma, and is included in seven NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for calcium gluconate. Eleven suppliers are listed for this compound.

Sponsor	Phase
Ascension Genesys Hospital	Phase 2
Aurora Health Care	Phase 4
First Affiliated Hospital Xi'an Jiaotong University	N/A

Sponsor

Phase

Ascension Genesys Hospital

Phase 2

Aurora Health Care

Phase 4

First Affiliated Hospital Xi'an Jiaotong University

N/A

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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
Somerset	CALCIUM GLUCONATE	calcium gluconate	SOLUTION;INTRAVENOUS	217689-001	Oct 19, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hq Spclt Pharma	CALCIUM GLUCONATE IN SODIUM CHLORIDE	calcium gluconate	SOLUTION;INTRAVENOUS	210906-001	Oct 29, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Hq Spclt Pharma	CALCIUM GLUCONATE IN SODIUM CHLORIDE	calcium gluconate	SOLUTION;INTRAVENOUS	210906-001	Oct 29, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
B Braun Medical Inc	CALCIUM GLUCONATE	calcium gluconate	SOLUTION;INTRAVENOUS	216541-001	Aug 21, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	CALCIUM GLUCONATE IN SODIUM CHLORIDE	calcium gluconate	SOLUTION;INTRAVENOUS	208418-005	Jun 17, 2021	AP	RX	Yes	Yes	⤷ 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:	2
Tradenames:	2
Applicants:	6
NDAs:	7
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	30
Patent Applications:	6,514
Drug Prices:	Drug price trends for calcium gluconate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for calcium gluconate
What excipients (inactive ingredients) are in calcium gluconate?	calcium gluconate excipients list
DailyMed Link:	calcium gluconate at DailyMed

Drug Class	Blood Coagulation Factor Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity
Physiological Effect	Increased Coagulation Factor Activity