MAGNESIUM SULFATE - Generic Drug Details

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

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, Bionpharma, Novel Labs Inc, Pai Holdings, Strides Pharma, and Taro, and is included in thirty-two 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.

Summary for MAGNESIUM SULFATE

US Patents:	4
Tradenames:	11
Applicants:	19
NDAs:	32
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	324
Patent Applications:	1,386
What excipients (inactive ingredients) are in MAGNESIUM SULFATE?	MAGNESIUM SULFATE excipients list
DailyMed Link:	MAGNESIUM SULFATE at DailyMed

Recent Clinical Trials for MAGNESIUM SULFATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Oklahoma	Early Phase 1
Daewoong Pharmaceutical Co. LTD.	Phase 3
Cairo University	Phase 1/Phase 2

See all MAGNESIUM SULFATE clinical trials

Generic filers with tentative approvals for MAGNESIUM SULFATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	1.6GM/BOT; 3.13GM/BOT; 17.5GM/BOT	SOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for MAGNESIUM SULFATE

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

Medical Subject Heading (MeSH) Categories for MAGNESIUM SULFATE

Analgesics
Anesthetics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Tocolytic Agents

US Patents and Regulatory Information for MAGNESIUM SULFATE

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Glossary

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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
Amneal	MAGNESIUM SULFATE IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	216597-001	Feb 15, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Braintree Labs	SUFLAVE	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	215344-001	Jun 15, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Exela Pharma	MAGNESIUM SULFATE	magnesium sulfate	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	206039-001	Dec 18, 2014		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Baxter Hlthcare	TIS-U-SOL	magnesium sulfate; potassium chloride; potassium phosphate, monobasic; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	018508-001	Feb 19, 1982	AT	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

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