Viewing data from:

GOLYTELY

NDA

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | N019011 | AZURITY PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of the Efficacy and Safety of Quiklean® and Klean-Prep With Dulcolax® for the Bowel Preparation Prior to Colonoscopy NCT03992365	Phase 3	Completed	Universal Integrated Corp.	472	2019-06-10 → 2020-01-15

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs (1 brand, 1 generic)

Highest NADAC/Unit

$0.0060

per ml

Lowest NADAC/Unit

$0.0046

per ml

Brand NDCs

Generic NDCs

Avg Brand: $0.0060

Avg Generic: $0.0046

22% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
52268010001GOLYTELY SOLUTION	$0.0060	ML	Brand	$0.0046	2026-06-17
10572010001PEG-3350 AND ELECTROLYTES SOLN	$0.0046	ML	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$7.14

Highest Price

$19.66

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
52268-0100-01GOLYTELY	$19.66	FSS	Sebela Pharmaceuticals, Inc.	03/31/2029
52268-0100-01GOLYTELY	$14.18	Big4	Sebela Pharmaceuticals, Inc.	03/31/2029
10572-0100-01PEG-3350/ELECTROLYTES PWDR	$19.65	FSS	Sebela Pharmaceuticals, Inc.	03/31/2029
10572-0100-01PEG-3350/ELECTROLYTES PWDR	$7.14	Big4	Sebela Pharmaceuticals, Inc.	03/31/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Golytely (2024)

Total Spending

$205K

Total Claims

8,171

Beneficiaries

7,584

Avg Cost/Unit

$0.01

Spending Trend

$331K(2019)→$501K(2020)→$330K(2021)→$452K(2022)→$261K(2023)→$205K(2024)

YoY Change:-0.2%

5yr CAGR:-44.1%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
May 17, 2021	SUPPL -33	View Letter (PDF)
Jun 8, 2020	SUPPL -31	View Letter (PDF)
Sep 24, 2013	SUPPL -25	View Letter (PDF)
Sep 19, 2002	SUPPL -15	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT

RLDAA

0 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Jul 13, 1984

No patent or exclusivity listings for this strength.

#002 — 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET

RLD

0 patents0 exclusivities▾

FOR SOLUTION;ORAL | Approved: Jun 2, 1992