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Last Updated: May 10, 2024

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 twelve 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, Taro, Alkem Labs Ltd, Novel Labs Inc, and Strides Pharma, and is included in thirty 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
Cukurova UniversityPhase 4
Southeastern Ontario Academic Medical Organization (SEAMO)Phase 4
Brigham and Women's HospitalPhase 2

See all MAGNESIUM SULFATE clinical trials

Generic filers with tentative approvals for MAGNESIUM SULFATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a 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 SUFLAVE magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate FOR SOLUTION;ORAL 215344-001 Jun 15, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hq Spclt Pharma MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 207350-004 Dec 6, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira MAGNESIUM SULFATE magnesium sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 075151-001 Apr 25, 2000 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
B Braun Medical Inc MAGNESIUM SULFATE magnesium sulfate INJECTABLE;INJECTION 207967-003 Apr 26, 2021 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 209911-001 Sep 14, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hq Spclt Pharma MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 207350-005 Dec 6, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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