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Last Updated: September 25, 2022

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

DrugPatentWatch® Generic Entry Outlook for Suprep Bowel Prep Kit

There have been six 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

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

SponsorPhase
University of VirginiaN/A
Seoul National University HospitalPhase 4
Bo-In LeePhase 4

See all SUPREP BOWEL PREP KIT clinical trials

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 one US patents and one FDA Regulatory Exclusivity.

Patents protecting SUPREP BOWEL PREP KIT

Salt solution for colon cleansing
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: GASTROINTESTINAL LAVAGE INDICATED FOR CLEANSING OF THE COLON AS A PREPARATION FOR COLONOSCOPY IN ADULTS

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: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Braintree Labs SUPREP BOWEL PREP KIT magnesium sulfate; potassium sulfate; sodium sulfate SOLUTION;ORAL 022372-001 Aug 5, 2010 AA RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
Spain 2441890 See Plans and Pricing
Hong Kong 1148935 SALT SOLUTION FOR COLON CLEANSING See Plans and Pricing
Cyprus 1114745 See Plans and Pricing
Slovenia 2233147 See Plans and Pricing
Hong Kong 1154492 SALT SOLUTION FOR COLON CLEANSING See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SUPREP BOWEL PREP KIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0984957 2012/048 Ireland See Plans and Pricing PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
1499331 C20130010 00080 Estonia See Plans and Pricing PRODUCT NAME: NAATRIUMSULFAAT, MAGNEESIUMSULFAATHEPTAHUEDRAAT JA;REG NO/DATE: RR-4/5 04.03.2013
0984957 122012000017 Germany See Plans and Pricing PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
0984957 C300517 Netherlands See Plans and Pricing PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
1020461 300482 Netherlands See Plans and Pricing PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
>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

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.