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.

Summary for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

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

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

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

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

See all MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE clinical trials

Pharmacology for MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

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

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

A06AD	Osmotically acting laxatives
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

A06AD	Osmotically acting laxatives
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

A12CA	Sodium
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

A12CC	Magnesium
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

V04CC	Tests for bile duct patency
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

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

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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
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
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
Pai Holdings	SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	209941-001	Jul 15, 2024	AA	RX	No	No	⤷ 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

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

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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

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