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Last Updated: March 28, 2024

Ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate - Generic Drug Details


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What are the generic drug sources for ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate and what is the scope of freedom to operate?

Ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate is the generic ingredient in three branded drugs marketed by Salix Pharms, Novel Labs Inc, and Salix, and is included in three NDAs. There are twelve patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate has two hundred and twelve patent family members in forty-one countries.

Four suppliers are listed for this compound.

Paragraph IV (Patent) Challenges for ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PLENVU For Oral Solution ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate 140 g, 5.2 g, 2.2.g, 48.11 g, 9 g and 7.54 g per pouch 209381 1 2018-12-06
MOVIPREP For Oral Solution ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate 100 g, 7.5 g, 2.691 g, 1.015 g, 5.9 g and 4.7 g per pouch 021881 1 2007-11-27

US Patents and Regulatory Information for ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Salix PLENVU ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate FOR SOLUTION;ORAL 209381-001 May 4, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novel Labs Inc PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate FOR SOLUTION;ORAL 090145-001 Jan 25, 2012 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Salix Pharms MOVIPREP ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate FOR SOLUTION;ORAL 021881-001 Aug 2, 2006 AA RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Salix PLENVU ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate FOR SOLUTION;ORAL 209381-001 May 4, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Salix PLENVU ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate FOR SOLUTION;ORAL 209381-001 May 4, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Salix PLENVU ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate FOR SOLUTION;ORAL 209381-001 May 4, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

International Patents for ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate

Country Patent Number Title Estimated Expiration
Slovenia 2895163 ⤷  Try a Trial
Japan 2008001724 COLON CLEANSING COMPOSITIONS ⤷  Try a Trial
Eurasian Patent Organization 201500320 КОМПОЗИЦИЯ (ВАРИАНТЫ) И РАСТВОР ДЛЯ ОЧИЩЕНИЯ ТОЛСТОЙ КИШКИ, ЛЕКАРСТВЕННОЕ СРЕДСТВО, НАБОР И СПОСОБ ОЧИЩЕНИЯ ТОЛСТОЙ КИШКИ (ВАРИАНТЫ) ⤷  Try a Trial
New Zealand 743984 Compositions comprising polyethylene glycol, alkali metal or alkaline earth metal sulphates and electrolytes for use as colon cleansing compositions ⤷  Try a Trial
Lithuania 2314319 ⤷  Try a Trial
South Africa 201304866 COLONOSCOPY-PREPARATION ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3141251 301099 Netherlands ⤷  Try a Trial PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016
3141251 132021000000044 Italy ⤷  Try a Trial PRODUCT NAME: UN PRODOTTO MEDICINALE COSTITUITO DA UNA COMBINAZIONE DI UNA PRIMA DOSE DI COMPOSIZIONE FARMACEUTICA E UNA SECONDA DOSE DI COMPOSIZIONE FARMACEUTICA, LA PRIMA DOSE DI COMPOSIZIONE FARMACEUTICA E COSTITUITA DAGLI INGREDIENTI ATTIVI POLIETILENGLICOLE, SOLFATO DI SODIO, CLORURO DI SODIO E CLORURO DI POTASSIO E LA SECONDA DOSE DI COMPOSIZIONE FARMACEUTICA E COSTITUITA DAGLI INGREDIENTI ATTIVI POLIETILENGLICOLE, ACIDO ASCORBICO, ASCORBATO DI SODIO, CLORURO DI SODIO E CLORURO DI POTASSIO.(PLENVU); AUTHORISATION NUMBER(S) AND DATE(S): IS/1/17/083/01, 20171016;045671017, 045671029, 045671031, 045671043, 045671056, 20171213
3141251 SPC/GB20/075 United Kingdom ⤷  Try a Trial PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS: POLYETHYLENE GLYCOL 3350, SODIUM SULPH; REGISTERED: IS IS/1/17/063/01 20171016; UK PL 20011/0040 20171016
3141251 C202130017 Spain ⤷  Try a Trial PRODUCT NAME: COMBINACION DE PRINCIPIOS ACTIVOS EN DOS DOSIS, EN LA QUE LA PRIMERA DOSIS CONSISTE EN LOS PRINCIPIOS ACTIVOS POLIETILENGLICOL, SULFATO DE SODIO, CLORURO DE SODIO Y CLORURO DE POTASIO, Y LA SEGUNDA DOSIS CONSISTE EN LOS PRINCIPIOS ACTIVOS POLIETILENGLICOL, ACIDO ASCORBICO, ASCORBATO DE SODIO, CLORURO DE SODIO Y CLORURO DE POTASIO.; NATIONAL AUTHORISATION NUMBER: 82959-SE/H/1801/001/DC; DATE OF AUTHORISATION: 20180525; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): IS/1/17/083/01; DATE OF FIRST AUTHORISATION IN EEA: 20171016
3141251 122021000018 Germany ⤷  Try a Trial PRODUCT NAME: EIN ARZNEIMITTEL BESTEHEND AUS EINER KOMBINATION EINER PHARMAZEUTISCHEN ZUSAMMENSETZUNG FUER EINE ERSTE DOSIS UND EINER PHARMAZEUTISCHEN ZUSAMMENSETZUNG FUER EINE ZWEITE DOSIS, WOBEI DIE PHARMAZEUTISCHE ZUSAMMENSETZUNG FUER DIE ERSTE DOSIS AUS DEN WIRKSTOFFEN POLYETHYLENGLYCOL, NATRIUMSULFAT, NATRIUMCHLORID UND KALIUMCHLORID BESTEHT UND DIE PHARMAZEUTISCHE ZUSAMMENSETZUNG FUER DIE ZWEITE DOSIS AUS DEN; NAT. REGISTRATION NO/DATE: 98450.00.00 20180205; FIRST REGISTRATION: ISLAND IS/1/17/083/01 20171016
>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 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.