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Last Updated: April 19, 2024

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Polyethylene glycol 3350 - Generic Drug Details

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What are the generic sources for polyethylene glycol 3350 and what is the scope of patent protection?

Polyethylene glycol 3350 is the generic ingredient in twenty-two branded drugs marketed by Lannett Co Inc, Bayer Healthcare Llc, Ani Pharms, Annora Pharma, Aurobindo Pharma Ltd, Breckenridge Pharm, Elysium, Lgm Pharma, Mylan, Nexgen Pharma Inc, Novel Labs Inc, Nuvo Pharms Inc, Paddock Llc, Perrigo R And D, Strides Pharma, Teva Pharms, L Perrigo Co, Braintree, Nostrum Labs Inc, Aurobindo Pharma Usa, Hospira, Mylan Speciality Lp, Vintage Pharms, Dynapharm, E Z Em, Goldline, and Sandoz, and is included in forty-one NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for polyethylene glycol 3350. Sixty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for polyethylene glycol 3350

US Patents:	0
Tradenames:	22
Applicants:	27
NDAs:	41
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	60
Raw Ingredient (Bulk) Api Vendors:	218
Clinical Trials:	302
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in polyethylene glycol 3350?	polyethylene glycol 3350 excipients list
DailyMed Link:	polyethylene glycol 3350 at DailyMed

Drug Sales Revenue Trends for polyethylene glycol 3350

See drug sales revenues for polyethylene glycol 3350

Recent Clinical Trials for polyethylene glycol 3350

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

Sponsor	Phase
Vanderbilt University Medical Center	Phase 2/Phase 3
Chad R. Tracy	Phase 4
Hospital de Clínicas Dr. Manuel Quintela	N/A

See all polyethylene glycol 3350 clinical trials

Generic filers with tentative approvals for POLYETHYLENE GLYCOL 3350

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	2MG; 5MG	SOLUTION; ORAL AND TABLET; DELAYED RELEASE

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for polyethylene glycol 3350

Drug Class	Osmotic Laxative
Mechanism of Action	Osmotic Activity
Physiological Effect	Stimulation Large Intestine Fluid/Electrolyte Secretion

US Patents and Regulatory Information for polyethylene glycol 3350

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	POLYETHYLENE GLYCOL 3350	polyethylene glycol 3350	FOR SOLUTION;ORAL	078915-001	Oct 6, 2009		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Speciality Lp	COLYTE	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	018983-006	Oct 26, 1984		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Strides Pharma	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride	FOR SOLUTION;ORAL	204559-001	Apr 13, 2015	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva Pharms	POLYETHYLENE GLYCOL 3350	polyethylene glycol 3350	FOR SOLUTION;ORAL	077445-001	May 4, 2006		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma Usa	TRILYTE	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride	FOR SOLUTION;ORAL	076491-001	Feb 5, 2004		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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

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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.