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suprep bowel prep kit Drug Patent Profile

Which patents cover Suprep Bowel Prep Kit, 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:	12
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

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
European Patent Office	1499331	SOLUTION SALINE POUR LE NETTOYAGE DU COLON (SALT SOLUTION FOR COLON CLEANSING)
Spain	2441890
Denmark	1499331
Slovenia	2233147
Spain	2375446
Austria	457172

Supplementary Protection Certificates for suprep bowel prep kit

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1020461	300482	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
1499331	C20130010 00080	Estonia		PRODUCT NAME: NAATRIUMSULFAAT, MAGNEESIUMSULFAATHEPTAHUEDRAAT JA;REG NO/DATE: RR-4/5 04.03.2013
0984957	CR 2012 00035	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
0984957	C300483	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
1499331	132013902184107	Italy		PRODUCT NAME: (SODIO SOLFATO + MAGNESIO SOLFATO + POTASSIO SOLFATO(IZINOVA); AUTHORISATION NUMBER(S) AND DATE(S): BE434323, 20130220;041807013/M, 20130610