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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 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 eighty-seven patent family members in thirty-nine countries.

There are six drug master file entries for ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate. Four suppliers are listed for this compound.

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

International Patents:	187
US Patents:	11
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	6
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

A06AD	Osmotically acting laxatives
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

A12BA	Potassium
A12B	POTASSIUM
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

A12CA	Sodium
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

A12CA	Sodium
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

B05CB	Salt solutions
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

G01AD	Organic acids
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

S01XA	Other ophthalmologicals
S01X	OTHER OPHTHALMOLOGICALS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
PLENVU	FOR SOLUTION;ORAL	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	209381	2018-12-06
MOVIPREP	FOR SOLUTION;ORAL	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	021881	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			Y
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			Y	Y
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
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			Y
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
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			Y
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			Y

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

Country	Patent Number	Estimated Expiration
South Korea	102234803
Denmark	2014304
Eurasian Patent Organization	027526
Singapore	192882
Hong Kong	1206604
Japan	2018039855
Mexico	343950

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	122021000018	Germany		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