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Last Updated: April 12, 2021

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Magnesium sulfate - Generic Drug Details

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

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.

Summary for magnesium sulfate
US Patents:2
Tradenames:10
Applicants:13
NDAs:23
Drug Master File Entries: 146
Suppliers / Packagers: 14
Bulk Api Vendors: 110
Clinical Trials: 227
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
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
Mylan Labs Ltd MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 209932-001 Sep 10, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 020309-004 Jan 18, 1995 AP RX Yes No   Start Trial   Start Trial   Start Trial
Hospira Inc MAGNESIUM SULFATE magnesium sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 202411-001 May 14, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Gland Pharma Ltd MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 213917-001 Jul 10, 2020 AP RX No No   Start Trial   Start Trial   Start Trial
Gator Pharms COLPREP KIT magnesium sulfate; potassium sulfate; sodium sulfate POWDER;ORAL 204553-001 Dec 27, 2016 DISCN Yes No   Start Trial   Start Trial   Start Trial
Baxter Hlthcare Corp MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 211966-001 Jun 1, 2020 DISCN No No   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:

Medtronic
Dow
Express Scripts
Baxter
McKinsey
Boehringer Ingelheim

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