FDA Orange Book · active-ingredient family
Magnesium sulfate
Magnesium sulfate: 3 brands, 18 generics; first approved Sep 08, 1986; generic available.
Generic available2 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 18 ANDA applications approved.
Latest exclusivity ends
Brands (NDA)
3
Generics (ANDA)
18
Listed patents
0
Presentations
53
Brand (NDA) products
Originator applications
- HOSPIRANDA 02030920075 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4GM/100ML (40MG/ML) INJECTABLE INJECTION Rx AP 4GM/50ML (80MG/ML) INJECTABLE INJECTION Rx AP 2GM/50ML (40MG/ML) INJECTABLE INJECTION Rx AP 20GM/500ML (40MG/ML) INJECTABLE INJECTION Rx AP 40GM/1000ML (40MG/ML) INJECTABLE INJECTION Rx AP - HOSPIRANDA 02048819952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML INJECTABLE INJECTION Rx AP 2GM/100ML INJECTABLE INJECTION Rx — - MAGNESIUM SULFATERLDRSFRESENIUS KABI USANDA 01931619864 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5GM/10ML (500MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx AP 1GM/2ML (500MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx AP 10GM/20ML (500MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx AP 25GM/50ML (500MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx AP
Generic (ANDA) products (18)
Abbreviated applications
- MAGNESIUM SULFATESQUARE PHARMS PLCANDA 21746120264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/2ML (500MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx AP 5GM/10ML (500MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx AP 10GM/20ML (500MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx AP 25GM/50ML (500MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx AP - MAGNESIUM SULFATERSBAXTER HLTHCARE CORPANDA 21196620264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2GM/50ML (40MG/ML) INJECTABLE INJECTION Rx AP 4GM/50ML (80MG/ML) INJECTABLE INJECTION Rx AP 4GM/100ML (40MG/ML) INJECTABLE INJECTION Rx AP 3GM/100ML (30MG/ML) INJECTABLE INJECTION Rx — - MAGNESIUM SULFATEASPIROANDA 21977720254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/2ML (500MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx AP 5GM/10ML (500MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx AP 10GM/20ML (500MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx AP 25GM/50ML (500MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx AP - AMNEALANDA 21659720232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2GM/50ML (40MG/ML) INJECTABLE INJECTION Rx AP 4GM/100ML (40MG/ML) INJECTABLE INJECTION Rx AP - MILLA PHARMSANDA 20964220213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2GM/50ML (40MG/ML) INJECTABLE INJECTION Rx AP 4GM/100ML (40MG/ML) INJECTABLE INJECTION Rx AP 4GM/50ML (80MG/ML) INJECTABLE INJECTION Rx AP - MAGNESIUM SULFATEB BRAUN MEDICALANDA 20796720213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2GM/50ML (40MG/ML) INJECTABLE INJECTION Rx AP 4GM/100ML (40MG/ML) INJECTABLE INJECTION Rx AP 4GM/50ML (80MG/ML) INJECTABLE INJECTION Rx AP - B BRAUN MEDICALANDA 2079662020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML INJECTABLE INJECTION Rx AP - BAXTER HLTHCARE CORPANDA 2119652020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML INJECTABLE INJECTION Rx AP - GLANDANDA 21391720202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2GM/50ML (40MG/ML) INJECTABLE INJECTION Rx AP 4GM/100ML (40MG/ML) INJECTABLE INJECTION Rx AP - PHARMOBEDIENTANDA 20991120182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2GM/50ML (40MG/ML) INJECTABLE INJECTION Discontinued — 4GM/100ML (40MG/ML) INJECTABLE INJECTION Discontinued — - PHARMOBEDIENTANDA 2099322018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML INJECTABLE INJECTION Rx AP - HQ SPCLT PHARMAANDA 20735020175 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2GM/50ML (40MG/ML) INJECTABLE INJECTION Rx AP 4GM/100ML (40MG/ML) INJECTABLE INJECTION Rx AP 4GM/50ML (80MG/ML) INJECTABLE INJECTION Rx AP 20GM/500ML (40MG/ML) INJECTABLE INJECTION Rx AP 40GM/1000ML (40MG/ML) INJECTABLE INJECTION Rx AP - FRESENIUS KABI USAANDA 20648520165 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4GM/100ML (40MG/ML) INJECTABLE INJECTION Rx AP 4GM/50ML (80MG/ML) INJECTABLE INJECTION Rx AP 2GM/50ML (40MG/ML) INJECTABLE INJECTION Rx AP 20GM/500ML (40MG/ML) INJECTABLE INJECTION Rx AP 40GM/1000ML (40MG/ML) INJECTABLE INJECTION Rx AP - FRESENIUS KABI USAANDA 2064862016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML INJECTABLE INJECTION Rx AP - HQ SPCLT PHARMAANDA 2073492016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML INJECTABLE INJECTION Rx AP - MAGNESIUM SULFATEHOSPIRAANDA 2024112015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/20ML (500MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx AP - MAGNESIUM SULFATEEXELA PHARMAANDA 2060392014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5GM/10ML (500MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Discontinued — - MAGNESIUM SULFATERSHOSPIRAANDA 0751512000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5GM/10ML (500MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- CGTFDA marketing exclusivity
8 mo ago
- CGTFDA marketing exclusivity
8 mo ago
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
40 yr 8 mo ago
Most recent approval
3 mo ago
Approvals span 1986–2026 across 21 FDA applications.
Brand (NDA) 314%
Generic (ANDA) 1886%
Magnesium sulfate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
