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Last Updated: March 29, 2024

Magnesium sulfate; potassium sulfate; sodium sulfate - Generic Drug Details


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What are the generic drug sources for magnesium sulfate; potassium sulfate; sodium sulfate and what is the scope of patent protection?

Magnesium sulfate; potassium sulfate; sodium sulfate is the generic ingredient in three branded drugs marketed by Gator Pharms, Alkem Labs Ltd, Novel Labs Inc, Strides Pharma, and Braintree Labs, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound.

Recent Clinical Trials for magnesium sulfate; potassium sulfate; sodium sulfate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Litholink CorpEarly Phase 1
Joshua SternEarly Phase 1
NorginePhase 4

See all magnesium sulfate; potassium sulfate; sodium sulfate clinical trials

Paragraph IV (Patent) Challenges for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SUPREP BOWEL PREP KIT Oral Solution magnesium sulfate; potassium sulfate; sodium sulfate 17.5 g/3.13 g/1.6 g 022372 1 2010-11-08

US Patents and Regulatory Information for magnesium sulfate; potassium sulfate; sodium sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gator Pharms COLPREP KIT magnesium sulfate; potassium sulfate; sodium sulfate POWDER;ORAL 204553-001 Dec 27, 2016 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE magnesium sulfate; potassium sulfate; sodium sulfate SOLUTION;ORAL 215469-001 Nov 22, 2023 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkem Labs Ltd SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE magnesium sulfate; potassium sulfate; sodium sulfate SOLUTION;ORAL 213924-001 Dec 29, 2023 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Braintree Labs SUPREP BOWEL PREP KIT magnesium sulfate; potassium sulfate; sodium sulfate SOLUTION;ORAL 022372-001 Aug 5, 2010 AA RX Yes Yes ⤷  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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