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SUPREP BOWEL PREP KIT Drug Patent Profile

When do Suprep Bowel Prep Kit patents expire, and what generic alternatives are available?

Suprep Bowel Prep Kit is a drug marketed by Braintree Labs and is included in one NDA.

The generic ingredient in SUPREP BOWEL PREP KIT is magnesium sulfate; potassium sulfate; sodium sulfate. There are one hundred and forty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the magnesium sulfate; potassium sulfate; sodium sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Suprep Bowel Prep Kit

A generic version of SUPREP BOWEL PREP KIT was approved as magnesium sulfate; potassium sulfate; sodium sulfate by TARO on March 19^th, 2024.

Summary for SUPREP BOWEL PREP KIT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	8
Patent Applications:	15
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SUPREP BOWEL PREP KIT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUPREP BOWEL PREP KIT
DailyMed Link:	SUPREP BOWEL PREP KIT at DailyMed

See drug prices for SUPREP BOWEL PREP KIT

Recent Clinical Trials for SUPREP BOWEL PREP KIT

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

Sponsor	Phase
University of Virginia	N/A
Seoul National University Hospital	Phase 4
Bo-In Lee	Phase 4

See all SUPREP BOWEL PREP KIT clinical trials

Pharmacology for SUPREP BOWEL PREP KIT

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 SUPREP BOWEL PREP KIT

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 SUPREP BOWEL PREP KIT

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 SUPREP BOWEL PREP KIT

SUPREP BOWEL PREP KIT is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting SUPREP BOWEL PREP KIT

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

Expired US Patents for SUPREP BOWEL PREP KIT

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

International Patents for SUPREP BOWEL PREP KIT

See the table below for patents covering SUPREP BOWEL PREP KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2003231160	SALT SOLUTION FOR COLON CLEANSING
Canada	2484303	SOLUTION SALINE POUR LE NETTOYAGE DU COLON (SALT SOLUTION FOR COLON CLEANSING)
European Patent Office	2292244	Solution salée pour le nettoyage du colon (Salt Solution for Colon Cleansing)
Portugal	2292244
Austria	457172
Denmark	2233147
Germany	60331220

Supplementary Protection Certificates for SUPREP BOWEL PREP KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1499331	C300615	Netherlands		PRODUCT NAME: NATRIUMSULFAAT, MAGNESIUMSULFAAT EN KALIUMSULFAAT; NAT. REGISTRATION NO/DATE: RVG 110863 20130417; FIRST REGISTRATION: BE 434323 20130220
1499331	C20130010 00080	Estonia		PRODUCT NAME: NAATRIUMSULFAAT, MAGNEESIUMSULFAATHEPTAHUEDRAAT JA;REG NO/DATE: RR-4/5 04.03.2013
1499331	SPC/GB13/034	United Kingdom		PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
1499331	C 2013 026	Romania		PRODUCT NAME: EZICLENCONCENTRAT PENTRU SOLUTIE ORALA AMESTEC DE 3 SARURI NA2SO4 MGSO4 K2SO4 AMESTEC DE SULFAT DE SODIU, SULFAT DEMAGNEZIU SI SULFAT DE POTASIU; NATIONAL AUTHORISATION NUMBER: RO 5417/2013/01; DATE OF NATIONAL AUTHORISATION: 20130228; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BEBE434323; DATE OF FIRST AUTHORISATION IN EEA: 20130220
1020461	C300482	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20101105
0984957	122012000017	Germany		PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812