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MOVIPREP

NDA

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE | N021881 | SALIX PHARMACEUTICALS INC

1 strength0 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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 Moviprep (2023)

Total Spending

$73K

Total Claims

548

Beneficiaries

517

Avg Cost/Unit

$131.13

Spending Trend

$4.6M(2019)→$991K(2020)→$459K(2021)→$131K(2022)→$73K(2023)

YoY Change:+9.9%

5yr CAGR:+5.8%

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Apr 8, 2022	SUPPL -24	View Letter (PDF)
Nov 6, 2019	SUPPL -20	View Letter (PDF)
Dec 20, 2018	SUPPL -17	View Letter (PDF)
Dec 19, 2013	SUPPL -16	View Letter (PDF)
Sep 13, 2013	SUPPL -15	View Letter (PDF)
Aug 30, 2012	SUPPL -12	View Letter (PDF)
May 3, 2011	SUPPL -8	View Letter (PDF)
Nov 4, 2010	SUPPL -10	View Letter (PDF)
Feb 7, 2008	SUPPL -3	View Letter (PDF)
Aug 7, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM

RLDAA

0 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Aug 2, 2006

No patent or exclusivity listings for this strength.