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. Five suppliers are listed for this compound. Additional details are available on the magnesium sulfate; potassium sulfate; sodium sulfate profile page.
Summary 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 |
Pharmacology for SUPREP BOWEL PREP KIT
Anatomical Therapeutic Chemical (ATC) Classes for SUPREP BOWEL PREP KIT
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: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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
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 | ⤷ Try a Trial | ⤷ Try a Trial |
>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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 1499331 | ⤷ Try a Trial | |
Germany | 60331220 | ⤷ Try a Trial | |
Cyprus | 1114745 | ⤷ Try a Trial | |
Cyprus | 1112522 | ⤷ Try a Trial | |
Denmark | 1499331 | ⤷ Try a Trial | |
Hong Kong | 1148935 | SALT SOLUTION FOR COLON CLEANSING | ⤷ Try a Trial |
>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 | 300483 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYDRAAT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105 |
0984957 | 2012/048 | Ireland | ⤷ Try a Trial | 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 |
0984957 | 1290006-4 | Sweden | ⤷ Try a Trial | PRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812 |
0984957 | CR 2012 00035 | Denmark | ⤷ Try a 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 |
0124495 | SPC/GB01/006 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727 |
1499331 | C 2013 026 | Romania | ⤷ Try a 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 |