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Last Updated: July 12, 2020

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SUPREP BOWEL PREP KIT Drug 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. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-seven patent family members in thirteen countries.

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. Two suppliers are listed for this compound. Additional details are available on the magnesium sulfate; potassium sulfate; sodium sulfate profile page.

US ANDA Litigation and Generic Entry Outlook for Suprep Bowel Prep Kit

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Paragraph IV (Patent) Challenges for SUPREP BOWEL PREP KIT
Tradename Dosage Ingredient NDA Submissiondate
SUPREP BOWEL PREP KIT SOLUTION;ORAL magnesium sulfate; potassium sulfate; sodium sulfate 022372 2010-11-08

US Patents and Regulatory Information for 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   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for SUPREP BOWEL PREP KIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0124495 SPC/GB01/006 United Kingdom   Start Trial PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
1499331 13C0055 France   Start Trial PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
1499331 C 2013 026 Romania   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
McKinsey
Express Scripts
McKesson
Medtronic

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