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Generated: June 25, 2019

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Magnesium sulfate; potassium sulfate; sodium sulfate - Generic Drug Details

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What are the generic drug sources for magnesium sulfate; potassium sulfate; sodium sulfate and what is the scope of magnesium sulfate; potassium sulfate; sodium sulfate patent protection?

Magnesium sulfate; potassium sulfate; sodium sulfate is the generic ingredient in three branded drugs marketed by Gator Pharms, Novel Labs Inc, and Braintree Labs, and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Magnesium sulfate; potassium sulfate; sodium sulfate has twenty-seven patent family members in thirteen countries.

There are one hundred and forty-six drug master file entries for magnesium sulfate; potassium sulfate; sodium sulfate. Three suppliers are listed for this compound.

US Patents and Regulatory Information for magnesium sulfate; potassium sulfate; sodium sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novel Labs Inc SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE magnesium sulfate; potassium sulfate; sodium sulfate SOLUTION;ORAL 202511-001 Feb 23, 2017 AA RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 Y ➤ Sign Up
Gator Pharms COLPREP KIT magnesium sulfate; potassium sulfate; sodium sulfate POWDER;ORAL 204553-001 Dec 27, 2016 DISCN Yes No ➤ 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

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Supplementary Protection Certificates for magnesium sulfate; potassium sulfate; sodium sulfate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1499331 2013C/049 Belgium ➤ Sign Up PRODUCT NAME: EZICLEN, CONCENTRE POUR BOISSON; AUTHORISATION NUMBER AND DATE: BE434323 20130220
1499331 C 2013 026 Romania ➤ Sign Up 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
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
0984957 2012/048 Ireland ➤ Sign Up 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 C300517 Netherlands ➤ Sign Up PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
0984957 122012000017 Germany ➤ Sign Up PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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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 verifification 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.