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FDA Orange Book · active-ingredient family

Magnesium sulfate; potassium chloride; sodium sulfate

Magnesium sulfate; potassium chloride; sodium sulfate: 1 brand, 1 generic; first approved Nov 10, 2020; generic available.

Generic available
Generic status & protection

Generic available — 1 ANDA application approved.

Earliest patent expiry Aug 04, 2037
Brands (NDA)
1
Generics (ANDA)
1
Listed patents
4
Next patent expiry
Aug 04, 2037
in 11 yr 3 mo
Originator applications

Brand (NDA) products

SUTABRLDRS
NDA 2131352020
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.225GM;0.188GM;1.479GMTABLETORALRxAB
Abbreviated applications

Generic (ANDA) products (1)

SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE
ANDA 2160952026
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.225GM;0.188GM;1.479GMTABLETORALRxAB
Protection horizon

Patent & exclusivity timeline

2026202820302032203420362038TodayPatent 11382864 — 2037-08-04Patent 11382864Patent 11033498 — 2037-08-04Patent 11033498Patent 11638697 — 2037-08-04Patent 11638697Patent 10143656 — 2037-08-04Patent 10143656
Patent expiryExclusivity endToday
Orange Book patent file

Listed patents

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11382864Aug 04, 2037in 11 yr 3 mo
U-3164
11033498Aug 04, 2037in 11 yr 3 mo
U-3164
11638697Aug 04, 2037in 11 yr 3 mo
Product
10143656Aug 04, 2037in 11 yr 3 mo
Product
FDA approval span

Approval history

First approval
Nov 10, 2020
5 yr 9 mo ago
Most recent approval
May 28, 2026
2 mo ago

Approvals span 2020–2026 across 2 FDA applications.

Brand (NDA) 150%
Generic (ANDA) 150%

Magnesium sulfate; potassium chloride; sodium 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.

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