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Last Updated: March 29, 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, Exela Pharma Scs Llc, Hospira Inc, Braintree Labs, Baxter Hlthcare, Gator Pharms, and Novel Labs Inc, and is included in eighteen 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. 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
Kasr El Aini HospitalN/A
Beni-Suef UniversityEarly Phase 1
University of Sao Paulo General HospitalPhase 3

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
Synonyms for magnesium sulfate
(C10-C16) Alkylalcohol sulfuric acid, magnesium salt
18939-43-0
22189-08-8
68081-97-0
7487-88-9
AB1009334
ACMC-1CFPL
AI3-02029
AKOS015902894
Anhydrous magnesium sulfate
Arrosalt 2327
Bitter salt
C10-C16 Alkyl alcohol sulfuric acid magnesium salt
Caswell No. 534
CCRIS 8411
CHEBI:32599
CHEMBL2021423
CSNNHWWHGAXBCP-UHFFFAOYSA-L
CTK3J2463
DB00653
DTXSID6042105
EC 231-298-2
EINECS 231-298-2
EINECS 242-691-3
EINECS 268-365-0
EPA Pesticide Chemical Code 050503
Epitope ID:158536
FT-0628097
HSDB 664
J-014575
J-519590
K281
KS-00000UUD
KSC492I6H
LS-88605
M1890
Magnesii sulfas
Magnesium sulfate (1:1)
Magnesium sulfate anhydrous
Magnesium sulfate dried
Magnesium sulfate dried pure, coarse
Magnesium Sulfate Heptahydrate Solution, 2.25%
Magnesium sulfate in dextrose 5% in plastic container
Magnesium Sulfate In Plastic Container
Magnesium sulfate, 97%, pure, anhydrous
Magnesium sulfate, 99%, extra pure, dried, contains 3 to 4 moles of water
Magnesium sulfate, 99%, for analysis, anhydrous
Magnesium sulfate, anhydrous
Magnesium sulfate, anhydrous granular
Magnesium sulfate, anhydrous powder
Magnesium sulfate, unspecified
Magnesium sulphate
Magnesium sulphate anhydrous
Magnesium(II) sulfate
Magnesiumsulfat
Magnesiumsulfate
MFCD00011110
MFCD00149787
MgO4S
MgSO4
ML30MJ2U7I
NSC 146179
OT-S
OT-S (drying agent)
Q288266
RTR-024156
Sal Angalis
Sal De sedlitz
SDA 15-062-07
SN 00
SR-01000944338
SR-01000944338-1
Sulfato de magnesio
Sulfuric acid magnesium salt
Sulfuric acid magnesium salt (1:1)
Sulfuric acid magnesium salt (VAN)
Sulfuric acid magnesiumsalt (1:1), hydrate (8CI,9CI)
Sulfuric acid, C10-16 alkyl ester, magnesium salt
Sulfuric acid, magnesium salt (1:1)
Sulfuric acid, mono-C10-16-alkyl esters, magnesium salts
sulphate of magnesia
Tomix OT
TR-024156
TRA0075186
UNII-DE08037SAB component CSNNHWWHGAXBCP-UHFFFAOYSA-L
UNII-ML30MJ2U7I

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 PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 020309-004 Jan 18, 1995 AP RX Yes 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
Hq Spclt Pharma MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 207350-004 Dec 6, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa MAGNESIUM SULFATE magnesium sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 019316-004 Jan 29, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Hospira MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 020309-003 Jan 26, 2007 AP RX 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.