POLYETHYLENE GLYCOL 3350 - Generic Drug Details

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What are the generic drug 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, Ppi-dac, Strides Pharma, Teva Pharms, L Perrigo Co, Braintree, Nostrum Labs Inc, Rising, Aurobindo Pharma Usa, Hospira, Norvium Bioscience, 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-three 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:	28
NDAs:	41
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	63
Raw Ingredient (Bulk) Api Vendors:	218
Clinical Trials:	305
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
University Hospitals Cleveland Medical Center	Phase 4
Changchun GeneScience Pharmaceutical Co., Ltd.	Phase 1
Jinling Hospital, China	N/A

See all POLYETHYLENE GLYCOL 3350 clinical trials

Generic filers with tentative approvals for POLYETHYLENE GLYCOL 3350

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	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
Braintree	GOLYTELY	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	019011-002	Jun 2, 1992		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Braintree	GOLYTELY	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	019011-001	Jul 13, 1984	AA	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Paddock Llc	CLENZ-LYTE	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	090769-001	Jun 7, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	POLYETHYLENE GLYCOL 3350	polyethylene glycol 3350	FOR SOLUTION;ORAL	203928-001	Aug 24, 2016		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novel Labs Inc	POLYETHYLENE GLYCOL 3350	polyethylene glycol 3350	FOR SOLUTION;ORAL	091077-001	Oct 6, 2009		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lannett Co Inc	GLYCOLAX	polyethylene glycol 3350	FOR SOLUTION;ORAL	076652-001	Jul 2, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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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