Magnesium sulfate - Generic Drug Details

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What are the generic drug sources for magnesium sulfate and what is the scope of patent protection?

Magnesium sulfate is the generic ingredient in eleven branded drugs marketed by B Braun Medical Inc, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hospira, Hq Spclt Pharma, Mylan Labs Ltd, Amneal, Gland Pharma Ltd, Milla Pharms, Exela Pharma, Braintree Labs, Baxter Hlthcare, Gator Pharms, Alkem Labs Ltd, Novel Labs Inc, and Strides Pharma, and is included in twenty-nine NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for magnesium sulfate. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.

Sponsor	Phase
Cukurova University	Phase 4
Southeastern Ontario Academic Medical Organization (SEAMO)	Phase 4
National Institutes of Health (NIH)	Phase 2

Sponsor

Phase

Cukurova University

Phase 4

Southeastern Ontario Academic Medical Organization (SEAMO)

Phase 4

National Institutes of Health (NIH)

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
Hq Spclt Pharma	MAGNESIUM SULFATE IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	207350-003	Dec 6, 2017	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	MAGNESIUM SULFATE IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	206485-002	Mar 15, 2016	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Labs Ltd	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	209932-001	Sep 10, 2018	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Labs Ltd	MAGNESIUM SULFATE IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	209911-001	Sep 14, 2018	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Milla Pharms	MAGNESIUM SULFATE IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	209642-001	Nov 8, 2021	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Baxter Hlthcare Corp	MAGNESIUM SULFATE IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	211966-002	Jun 1, 2020	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	4
Tradenames:	11
Applicants:	16
NDAs:	29
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	314
Patent Applications:	1,386
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in magnesium sulfate?	magnesium sulfate excipients list
DailyMed Link:	magnesium sulfate at DailyMed

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	1.6GM/BOT; 3.13GM/BOT; 17.5GM/BOT	SOLUTION;ORAL

Drug Class	Calculi Dissolution Agent Osmotic Laxative
Mechanism of Action	Magnesium Ion Exchange Activity Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Inhibition Small Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion