Polyethylene Glycol 4000 with electrolytes — Competitive Intelligence Brief

Polyethylene Glycol 4000 with electrolytes (Polyethylene Glycol 4000 with electrolytes) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Osmotic laxative. Area: Gastroenterology.

marketed Osmotic laxative Gastroenterology Small molecule

Target snapshot

Polyethylene Glycol 4000 with electrolytes (Polyethylene Glycol 4000 with electrolytes) — Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Polyethylene glycol 4000 with electrolytes acts as an osmotic laxative that draws water into the bowel lumen while the electrolytes maintain fluid and electrolyte balance.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Polyethylene Glycol 4000 with electrolytes TARGET	Polyethylene Glycol 4000 with electrolytes	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	marketed	Osmotic laxative
Pizensy	LACTITOL	Braintree Labs	marketed	Osmotic Laxative		2020-01-01
Miralax	Macrogol	Braintree	marketed	Osmotic Laxative [EPC]		1984-01-01
Cephulac	LACTULOSE	Sanwa Kagaku Kenkyusho Co., Ltd.	marketed	Osmotic Laxative [EPC]		1976-01-01
Milk of Magnesia	magnesium hydroxide	Generic (multiple manufacturers)	marketed	Osmotic laxative, Antacid	Gastric acid (direct neutralization) + osmotic effect in intestine	1880-01-01
PEG/electrolytes 2L/2L split dose	PEG/electrolytes 2L/2L split dose	McGill University Health Centre/Research Institute of the McGill University Health Centre	marketed	Osmotic laxative
Polyethelene Glycol	Polyethelene Glycol	St. Joseph's Healthcare Hamilton	marketed	Osmotic laxative

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

• 2032-03-09 — Miralax · 10780112 · US
• 2032-03-09 — Miralax · 11529368 · US
• 2032-03-09 — Miralax · 10792306 · US
• 2032-03-25 — Miralax · 10646512 · US
• 2032-08-11 — Miralax · 9592252 · US
• 2033-09-10 — Miralax · 9326969 · US
• 2033-09-10 — Miralax · 9707297 · US
• 2033-09-10 — Miralax · 8999313 · US
• 2033-09-10 — Miralax · 10918723 · US
• 2033-09-10 — Miralax · 10016504 · US

Sponsor landscape (Osmotic laxative class)

1. Brooke Army Medical Center · 2 drugs in this class
2. Cleveland Clinic Florida · 2 drugs in this class
3. Gastroenterology Services, Ltd. · 2 drugs in this class
4. Ipsen · 2 drugs in this class
5. Benaroya Research Institute · 1 drug in this class
6. Bo-In Lee · 1 drug in this class
7. Amsterdam UMC, location VUmc · 1 drug in this class
8. C.B. Fleet Company, Inc. · 1 drug in this class
9. Bayer · 1 drug in this class
10. Braintree Laboratories · 1 drug in this class