Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride - Generic Drug Details

What are the generic sources for polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride and what is the scope of patent protection?

Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride is the generic ingredient in nineteen branded drugs marketed by L Perrigo Co, Braintree, Mylan, Nostrum Labs Inc, Novel Labs Inc, Strides Pharma, Aurobindo Pharma Usa, Paddock Llc, Hospira, Mylan Speciality Lp, Vintage Pharms, Dynapharm, E Z Em, Goldline, and Sandoz, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride

US Patents:	0
Tradenames:	19
Applicants:	15
NDAs:	22
Finished Product Suppliers / Packagers:	4
Clinical Trials:	1
DailyMed Link:	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride at DailyMed

Recent Clinical Trials for polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Temple University	Phase 4

See all polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride clinical trials

Pharmacology for polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride

Drug Class	Osmotic Laxative Potassium Salt
Mechanism of Action	Osmotic Activity Alkalinizing Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion

US Patents and Regulatory Information for polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride

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	PEG 3350 AND ELECTROLYTES	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	090231-001	Jun 1, 2009	AA	RX	No	No
Mylan Speciality Lp	COLYTE-FLAVORED	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	018983-009	Nov 14, 1991		DISCN	No	No
Mylan Speciality Lp	COLYTE	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	018983-010	Jan 31, 1989		DISCN	No	No
Nostrum Labs Inc	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride	FOR SOLUTION;ORAL	202060-001	Mar 8, 2017		DISCN	No	No
Mylan	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride	FOR SOLUTION;ORAL	090409-001	Apr 2, 2010		DISCN	No	No
E Z Em	E-Z-EM PREP LYTE	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SUSPENSION;ORAL	071278-001	Nov 21, 1988		DISCN	No	No