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SUPREP BOWEL PREP KIT Drug Patent Profile

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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.

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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
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

Drug patent expirations by year 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
Pharmbio Korea Co., Ltd.	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

FOR CLEANSING OF THE COLON AS A PREPARATION FOR COLONOSCOPY IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Sign Up

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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
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

Expired US Patents for SUPREP BOWEL PREP KIT

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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

International Patents for SUPREP BOWEL PREP KIT

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

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Country	Patent Number	Title	Estimated Expiration
Denmark	1499331		⤷ Sign Up
Portugal	2233147		⤷ Sign Up
Portugal	1499331		⤷ Sign Up
Japan	2005530743		⤷ Sign Up
European Patent Office	2233147	Solution salée pour le nettoyage du colon (Salt solution for colon cleansing)	⤷ Sign Up
Portugal	2292244		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for SUPREP BOWEL PREP KIT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	CR 2012 00035	Denmark	⤷ Sign Up	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
1499331	2013C/049	Belgium	⤷ Sign Up	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
1499331	SPC/GB13/034	United Kingdom	⤷ Sign Up	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	C20130010 00080	Estonia	⤷ Sign Up	PRODUCT NAME: NAATRIUMSULFAAT, MAGNEESIUMSULFAATHEPTAHUEDRAAT JA;REG NO/DATE: RR-4/5 04.03.2013
1499331	122014000007	Germany	⤷ Sign Up	PRODUCT NAME: NATRIUMSULFAT, MAGNESIUMSULFAT UND KALIUMSULFAT; NAT. REGISTRATION NO/DATE: 86203.00.00 20130808; FIRST REGISTRATION: BELGIEN BE434323 20130220
0984957	122012000051	Germany	⤷ Sign Up	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