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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Golytely (2023)

Total Spending

$261K

Total Claims

10,791

Beneficiaries

10,172

Avg Cost/Unit

$0.01

Spending Trend

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

YoY Change:+7.2%

5yr CAGR:-80.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

4 letters from Drugs@FDA

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