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Last Updated: July 12, 2020

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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 nine branded drugs marketed by Fresenius Kabi Usa, Hospira, Hq Spclt Pharma, Mylan Labs Ltd, Baxter Hlthcare Corp, Exela Pharma Scs Llc, Hospira Inc, Braintree Labs, Baxter Hlthcare, Gator Pharms, and Novel Labs Inc, and is included in nineteen NDAs. There is one patent 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. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for magnesium sulfate

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SponsorPhase
Dow University of Health SciencesEarly Phase 1
Eric AlbrechtN/A
Wright State UniversityPhase 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
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
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
Novel Labs Inc SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE magnesium sulfate; potassium sulfate; sodium sulfate SOLUTION;ORAL 202511-001 Feb 23, 2017 AA RX No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial   Start Trial
Hq Spclt Pharma MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 207350-005 Dec 6, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Braintree Labs SUCLEAR magnesium sulfate; polyethylene glycol 3350; potassium chloride; potassium sulfate; sodium bicarbonate; sodium chloride; sodium sulfate SOLUTION;ORAL 203595-001 Jan 18, 2013 DISCN Yes 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

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.