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Last Updated: February 27, 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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Drug patent expirations by year for SUPREP BOWEL PREP KIT
Drug Prices for SUPREP BOWEL PREP KIT

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Recent Clinical Trials for SUPREP BOWEL PREP KIT

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SponsorPhase
Bo-In LeePhase 4
Pharmbio Korea Co., Ltd.Phase 4
Mercy Medical Center, Des Moines, IowaN/A

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Recent Litigation for SUPREP BOWEL PREP KIT

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District Court Litigation
Case NameDate
BRAINTREE LABORATORIES, INC. v. HETERO LABS LIMITED2019-07-22
Braintree Laboratories, Inc. v. Lannett Company, Inc.2017-03-20
Braintree Laboratories, Inc. v. Novel Laboratories, Inc.2015-06-04

See all SUPREP BOWEL PREP KIT litigation

Synonyms for SUPREP BOWEL PREP KIT
1226807-19-7
DTXSID00153681
Magnesium sulfate anhydrous; potassium sulfate; sodium sulfate
Magnesium sulfate mixture with potassium sulfate and sodium sulfate
Suprep
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
1499331 2013C/049 Belgium   Start Trial PRODUCT NAME: EZICLEN, CONCENTRE POUR BOISSON; AUTHORISATION NUMBER AND DATE: BE434323 20130220
0984957 122012000051 Germany   Start Trial 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
0984957 CR 2012 00035 Denmark   Start Trial 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 C300517 Netherlands   Start Trial PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
1499331 122014000007 Germany   Start Trial PRODUCT NAME: NATRIUMSULFAT, MAGNESIUMSULFAT UND KALIUMSULFAT; NAT. REGISTRATION NO/DATE: 86203.00.00 20130808; FIRST REGISTRATION: BELGIEN BE434323 20130220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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