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Last Updated: February 26, 2021

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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 ten branded drugs marketed by B Braun Medical Inc, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hospira, Hq Spclt Pharma, Mylan Labs Ltd, Gland Pharma Ltd, Exela Pharma, Hospira Inc, Braintree Labs, Baxter Hlthcare, Gator Pharms, and Novel Labs Inc, and is included in twenty-three NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are one hundred and forty-six drug master file entries for magnesium sulfate. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for magnesium sulfate

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

SponsorPhase
University of LouisvilleN/A
Fayoum UniversityPhase 4
Eric AlbrechtPhase 4

See all magnesium sulfate clinical trials

Generic filers with tentative approvals for MAGNESIUM SULFATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1.6GM/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.

Medical Subject Heading (MeSH) Categories for magnesium sulfate

US Patents and Regulatory Information for magnesium sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Braintree Labs SUTAB (COPACKAGED) magnesium sulfate; potassium chloride; sodium sulfate TABLET;ORAL 213135-001 Nov 10, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Braintree Labs SUPREP BOWEL PREP KIT magnesium sulfate; potassium sulfate; sodium sulfate SOLUTION;ORAL 022372-001 Aug 5, 2010 AA RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Hospira MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 020488-001 Jul 11, 1995 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Hq Spclt Pharma MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 207350-004 Dec 6, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 020309-001 Jun 24, 1994 AP RX Yes Yes   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

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Serving leading biopharmaceutical companies globally:

McKesson
McKinsey
Baxter
Moodys
Johnson and Johnson
Colorcon

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