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Last Updated: November 27, 2022

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, Milla Pharms, Exela Pharma, Braintree Labs, Baxter Hlthcare, Gator Pharms, and Novel Labs Inc, and is included in twenty-five 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
Recent Clinical Trials for magnesium sulfate

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

SponsorPhase
Aalborg University HospitalPhase 4
Konya Meram State HospitalN/A
Litholink CorpEarly Phase 1

See all magnesium sulfate clinical trials

Generic filers with tentative approvals for MAGNESIUM SULFATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing1.6GM/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
Hq Spclt Pharma MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 207350-002 Dec 6, 2017 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hospira MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 020488-001 Jul 11, 1995 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Labs Ltd MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 209911-002 Sep 14, 2018 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hq Spclt Pharma MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 207349-001 Mar 2, 2016 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fresenius Kabi Usa MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 206485-001 Mar 15, 2016 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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.