Magnesium Sulfate Patent Expiration

Magnesium Sulfate was first introduced by Fresenius Kabi Usa Llc in its drug Magnesium Sulfate on Sep 8, 1986. Other drugs containing Magnesium Sulfate are Magnesium Sulfate In Dextrose 5% In Plastic Container, Magnesium Sulfate In Plastic Container. 12 different companies have introduced drugs containing Magnesium Sulfate.


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Clinical Trials

Recent Clinical Trials on Magnesium Sulfate:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Intra-arterial Selective Hypothermic Magnesium Sulfate Infusion in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke Capital Medical University NA ENROLLING BY INVITATION
(Aug 1, 2026)
PHASE1, PHASE2
Magnesium Supplementation in Advanced Non-small Cell Lung Cancer (NSCLC) Swiss Cancer Institute NA RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3
Oral Versus Intravenous Magnesium on Emergence Delirium Tanta University NA RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3
MAGNEsium With meToprolol for Rate Control In Atrial Fibrillation Wake Forest University Health Sciences NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE3
Post-CA Neuroprotection With Magnesium NYU Langone Health NA RECRUITING
(Apr 1, 2026)
PHASE1
Antenatal Magnesium Sulphate in High-Risk Preterm Patients Cairo University NA RECRUITING
(Apr 1, 2026)
PHASE3
Intra-Arterial Neuroprotective Agents and Cold Saline in Ischemic Stroke Intervention Northwell Health NA WITHDRAWN
(Mar 1, 2026)
PHASE1


Magnesium Sulfate Generic API Manufacturers

Several generic applications have been filed for Magnesium Sulfate. The first generic version for Magnesium Sulfate was by Hospira Inc and was approved on Apr 25, 2000. And the latest generic version is by Square Pharmaceuticals Plc and was approved on Jul 9, 2026.

Given below is the list of companies who have filed for Magnesium Sulfate generic, along with the locations of their manufacturing plants worldwide.