Viewing data from:

NULYTELY

NDA

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | N019797 | 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 Nulytely (2023)

Total Spending

$2K

Total Claims

102

Beneficiaries

102

Avg Cost/Unit

$0.01

Spending Trend

$48K(2020)→$146K(2021)→$69K(2022)→$2K(2023)

YoY Change:+5.6%

5yr CAGR:+1.0%

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

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT

RLDAA

0 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Apr 22, 1991

No patent or exclusivity listings for this strength.

#002 — 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT

RLDAA

0 patents0 exclusivities▾

FOR SOLUTION;ORAL | Approved: Nov 18, 1994