MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE - Generic Drug Details

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What are the generic 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, Bionpharma, Novel Labs Inc, Pai Holdings, Strides Pharma, Taro, and Braintree Labs, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Seven suppliers are listed for this compound.

Sponsor	Phase
Daewoong Pharmaceutical Co. LTD.	Phase 3
Jinling Hospital, China	N/A
Joshua Stern	Early Phase 1

Sponsor

Phase

Daewoong Pharmaceutical Co. LTD.

Phase 3

Jinling Hospital, China

N/A

Joshua Stern

Early Phase 1

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

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

2010-11-08

US Patents and Regulatory Information for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bionpharma	SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	204135-001	Jun 24, 2024	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gator Pharms	COLPREP KIT	magnesium sulfate; potassium sulfate; sodium sulfate	POWDER;ORAL	204553-001	Dec 27, 2016		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	206431-001	Mar 19, 2024	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Braintree Labs	SUPREP BOWEL PREP KIT	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	022372-001	Aug 5, 2010	AA	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Braintree Labs	SUPREP BOWEL PREP KIT	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	022372-001	Aug 5, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Applicant

Tradename

Generic Name

Dosage

NDA

Approval Date

Patent No.

Patent Expiration

Braintree Labs

SUPREP BOWEL PREP KIT

magnesium sulfate; potassium sulfate; sodium sulfate

SOLUTION;ORAL

022372-001

Aug 5, 2010

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>Applicant

>Tradename

>Generic Name

>Dosage

>NDA

>Approval Date

>Patent No.

>Patent Expiration

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US Patents:	0
Tradenames:	3
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	7
Clinical Trials:	10
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE
DailyMed Link:	MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE at DailyMed

Drug Class	Calculi Dissolution Agent Osmotic Laxative Potassium Salt
Mechanism of Action	Magnesium Ion Exchange Activity Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Inhibition Small Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion

MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE - Generic Drug Details

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

Summary for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

Recent Clinical Trials for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

Pharmacology for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

Anatomical Therapeutic Chemical (ATC) Classes for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

Paragraph IV (Patent) Challenges for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

US Patents and Regulatory Information for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

Expired US Patents for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

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