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, Taro, and Salix, and is included in four NDAs. There are eleven 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 one hundred and sixty-five patent family members in thirty-seven countries.
Four suppliers are listed for this compound.
Summary for ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate
| International Patents: | 165 |
| US Patents: | 11 |
| Tradenames: | 3 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 4 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate |
| DailyMed Link: | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate at DailyMed |
Anatomical Therapeutic Chemical (ATC) Classes for ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate
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 | 10,780,112 | ⤷ Start Trial | Y | ⤷ Start 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 | 10,016,504 | ⤷ Start Trial | Y | ⤷ Start 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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 | 10,918,723 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Taro | 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 | 207498-001 | Jun 28, 2024 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 | 8,999,313 | ⤷ 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 |
Expired US Patents for ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Salix Pharms | MOVIPREP | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | FOR SOLUTION;ORAL | 021881-001 | Aug 2, 2006 | 7,169,381 | ⤷ Start 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 | 7,658,914 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 092500 | ⤷ Start Trial | |
| Australia | 2013314442 | ⤷ Start Trial | |
| Australia | 2015228962 | ⤷ Start Trial | |
| Australia | 2018204694 | ⤷ Start Trial | |
| Brazil | 112015005270 | ⤷ Start Trial | |
| Brazil | 112016019914 | ⤷ Start 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 | 132021000000044 | Italy | ⤷ Start 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 | 301099 | Netherlands | ⤷ Start 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 | 122021000018 | Germany | ⤷ Start 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 |
| 3141251 | C202130017 | Spain | ⤷ Start 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 | SPC/GB20/075 | United Kingdom | ⤷ Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
