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Last Updated: January 28, 2020

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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, Novel Labs Inc, and Braintree Labs, and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Magnesium sulfate; potassium sulfate; sodium sulfate has twenty-seven patent family members in thirteen countries.

There are one hundred and forty-six drug master file entries for magnesium sulfate; potassium sulfate; sodium sulfate. Two 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
Haining Health-Coming Biotech Co., Ltd.Phase 2
Mercy Medical Center, Des Moines, IowaN/A
Medical College of WisconsinN/A

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

Recent Litigation for magnesium sulfate; potassium sulfate; sodium sulfate

Identify potential future generic entrants

District Court Litigation
Case NameDate
BRAINTREE LABORATORIES, INC. v. HETERO LABS LIMITED2019-07-22
Braintree Laboratories, Inc. v. Lannett Company, Inc.2017-03-20
Braintree Laboratories, Inc. v. Novel Laboratories, Inc.2015-06-04

See all magnesium sulfate; potassium sulfate; sodium sulfate litigation

Paragraph IV (Patent) Challenges for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE
Tradename Dosage Ingredient NDA Submissiondate
SUPREP BOWEL PREP KIT SOLUTION;ORAL magnesium sulfate; potassium sulfate; sodium sulfate 022372 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
Braintree Labs SUPREP BOWEL PREP KIT magnesium sulfate; potassium sulfate; sodium sulfate SOLUTION;ORAL 022372-001 Aug 5, 2010 AA RX Yes Yes   Start Trial   Start Trial Y   Start 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   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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for magnesium sulfate; potassium sulfate; sodium sulfate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1499331 13C0055 France   Start Trial PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
1499331 C300615 Netherlands   Start Trial PRODUCT NAME: NATRIUMSULFAAT, MAGNESIUMSULFAAT EN KALIUMSULFAAT; NAT. REGISTRATION NO/DATE: RVG 110863 20130417; FIRST REGISTRATION: BE 434323 20130220
0984957 122012000051 Germany   Start Trial PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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